Dr. Ludwig Huber -
Chief Advisor - Global ISO 17025 and FDA/EU Compliance
|
Contact:
E-mail:
ludwig_huber@labcompliance.com
|
Ludwig Huber offers new in-Person Workshops
Labcompliance has extended the offerings for in-Person workshops
in several areas: "Computer System Validation and Part 11/Annex 11
Compliance", "GMP Compliance for Quality Control and Contract
Laboratories",. "Analytical Method Validation, Verification and
Transfer", "Analytical Instrument Qualification and System
Validation" and "Validation and Part 11 Compliance in Laboratories".
All workshops can be delivered as public and as in-house workshops.
Public workshops typically are organized and managed by professional
conference providers. In-house seminars are organized either by
professional conference providers or by the end-user company. For a
complete list of workshops with ordering process and links to pages
with individual contents,
click here.
Testimonials for Ludwig Huber's Seminars and Compliance Packages
Click here
Qualification for Compliance
(for a short summary,
click here)
Qualification for Compliance
(for a detailed list,
click here)
Dr. Ludwig Huber is a leading expert for FDA and equivalent international
compliance and for ISO/IEC 17025 laboratory accreditation.
While the FDA and other agencies do not provide certification of
compliance for private persons, service providers to regulated industry
should demonstrate expertise and knowledge. Dr. Ludwig Huber has
demonstrated this expertise and knowledge in many areas ranging from simple
literature publications and conference presentations to text books,
multiple-day workshops, participation in industry
and regulatory task task forces and more than 25 years of industry
experience. Below please find the list.
- Good Laboratory Practice and Good Manufacturing Practice, Agilent
Technologies
This book has been translated into 10 different languages. More than
150,000 copies have been distributed.
- Validation of Computerized Analytical Systems (1995), Interpharm
Was the publisher's Best Selling Book in 1996/7
This was the first book describing the 4Q lifecycle model for
laboratory equipment qualification and computer validation
- Validation and Qualification in Analytical Laboratories (1998,
updated in 2007)
- Validation of Computerized Analytical and Networked Systems (2002)
Literature and online Publications
published through www.labcompliance.com
- ISO/IEC 17025
- Good Laboratory Practice Regulations
- Analytical instrument qualification
- Computer System Validation
- 21 CFR Part 11
- Risk Assessment
With audio seminars, master plans, SOPs and examples
- ISO/IEC 17025
- Network Qualification
- Computer System Validation
- 21 CFR Part 11
- Macros and Spreadsheets
- Laboratory Compliance
- FDA Inspections
Ranging from 45 minutes to several days
- More than 200 presentations and/or workshops at conferences
- Selected as the IVT Speaker of the Year in 2002 out of 170
presenters
- More than 250 live audio, video and/or web seminars with up to
2000 attendees per session
Presented for Labcompliance, IVT, ComplianceOnline,
GlobalCompliancePannel, FXConferences, Agilent Technologies
- This includes events and trainings with
and for the US FDA, PIC/S, ISPE, GAMP, ECA, PDA, IVT, several national
health care agency such as China SFDA/FDA, Korean FDA (now MFDS),
Singapore HSA, Philippine FDA,
IDMA (India), Peking University, USP, Institute of Drug Control
(IDC) Vietnam, Ministry of Health and Welfare (MOHW),
Thai land and many pharmaceutical organizations.
Working with the US FDA
and PIC/S
- Workshop Leader at FDA Conferences
- Leader of panel discussions with FDA presentations
- Validation seminar at FDA CDER Rockville
- Presentation at worldwide PIC/S workshops
- Review of FDA internal documents
Industry Compliance Experience
- Responsible for the FDA compliance program at Hewlett-Packard and
Agilent for more than 20 years
- Consulting and training of pharmaceutical industry and testing laboratories on validation and compliance
for more than 20 years
Laboratory Experience
- Thesis about development of gas chromatographic methods
- Applications chemist for gas chromatographic environmental an
petrochemical analysis
- Managing the Agilent HPLC applications lab for environmental, food
and pharmaceutical analysis
Task Forces
- PDA Part 11 Task force
- IVT Network Qualification
- GAMP America Special Interest Group: Validation of Laboratory
Systems
- German federal/states GLP committee to interpret OECD consensus
documents
Member of Advisory Boards (Current and/or past)
- Pharmaceutical Technology Europe
- European Compliance Academy
- IVT Validation Journal
- Board member of 21CFRPart11 Compliance - Newsletter
- Advisory Board for Journal of Accreditation and Quality Assurance in
Laboratories
Awards
Working with the US FDA
and PIC/S
- Workshop Leader at FDA Conferences
- Leader of panel discussions with FDA presentations
- Validation seminar at FDA CDER Rockville
- Presentation at worldwide PIC/S workshops
- Review of FDA internal documents
Summary of Achievements
(past or present)
-
Presenter at conferences/meetings of: PIC/S, PDA,
ISPE, GAMP, US FDA, ECA, HSA (Singapore), SFDA (Shanghai, Peking), KFDA
(Seoul), IDMA
(India), Peking University, USP, Institute of Drug Control (IDC)
Vietnam, Ministry of Health and Welfare (MOHW) Thai land.
- More than 20 years of industry experience with validation
and compliance
- Editor and main author of
www.labcompliance.com
- Chief Advisor for Agilent Technologies
- Chairman, presenter and panel discussion member
at US-FDA Industry Training sessions and conferences
- Member of the advisory board for the European
Compliance Academy (ECA)
- Member of the US PDA task force on 21 CFR Part11
- Member of the GAMP special interest group: lab
equipment
- Member of IVT task force: IT Infrastructure &
Network Qualification
- Presenter of the Year of the Institute for
Validation and Technology
- Member of scientific advisory board of IVT's GxP
Journal
- Board member of Pharmaceutical Technology Europe
- Lifetime International GLP Award from Indian Drug
Manufacturer Association for Publications and Presentations in the Area
of GLP and GMP
- Author of three validation books and more than
100 publications
- 150+ web/audio/video seminars related to
compliance
Testimonials - Feedback on Ludwig Huber's
seminars/workshops/presentations
All the testimonials have been received through the feedback forms to
Labcompliance seminars, Compliance packages. and SOPs The authors agreed to
publish them. All information on the submitters of the testimonials can be
reviewed in the Labcompliance archive.
-
Labcompliance Documentation,
e.g., SOPs
Feedback: Mr. Huber and Labcompliance has been catalytic in our process
reorganizing and reconstruction of SOPs. A great source of knowledge and
lifelong experience that helped us meet the standards in a professional
and credible manner. Mr. Fotis Stathopoulos, Managing
Director of Infoset, Greece, Infoset is a specialized consulting
firm focusing on the pharmaceutical industry. Infoset aims to
fundamentally transform the way clinical data is collected, analyzed and
managed. (Ref
3001)
-
ISO 17025 Accreditation Package
Feedback: The package did exceed my expectations. The ISO 17025
Labcompliance Accreditation package is very insightful, practical, easy
to understand, and there are a ton of additional resources offered to
download when you have purchased this package for your laboratory
accreditation and implementation of ISO 17025. Our Laboratory Manager,
myself (quality manager, safety chair, director of special projects),
and our Vice President of Operations are all very glad that I chose to
buy the Labcompliance package. Just after two implementation meetings,
the vice president of operations said "wow, this is actually good", and
referring to certain sections of the laboratory quality manual: "this is
good stuff!".
The manual uses a consistent structure and terminology which applies
throughout the manual and SOP's which makes it very easy to understand
and incorporate into your companies existing quality management system,
or to implement for the first time a great laboratory quality management
system. I highly recommend the complete ISO 17025 Laboratory
Accreditation Package to any company with a testing / calibration
laboratory. Trust me, I have done my research and due diligence. This is
the best one out there; don't waste your time looking for others that
could lead you down a wrong path. When you get this package and start
reviewing it, you will say to yourself "this is a LOT of work"; but then
you will say, "Boy am I glad I bought this!"
Mr. Andrew Glum, Director of
Special Products and Quality Manager, Madge Tech, Inc., USA, l, (Ref 1085)
-
Computer System Validation Package
Background: Mr. Luistro has bought the CSV package in
preparation for an FDA inspection. Here is the feedback after he
had received the package:
The package did exceed my expectations. The CSV package is very
comprehensive and complete. The CSV package is a
must for every IT Department gearing towards FDA Aligned
documents. It is simple but very effective.
And he had additional Feedback after the FDA Inspection:
Hello Sir Ludwig,, We have passed the FDA Audit just concluded
yesterday.
Thanks for your SOP and Templates. It help me a lot understand
and explain to the auditor our own CSV Procedures. All documents
are very helpful.
Thanks a lot!, Regards,
ANTHONY JONATHAN LUISTRO MCT, MCITP, CCNP, Linux+ MIS Manager
MIS Section, Administration Department, Terumo (Phils)
Corporation
(Ref 1142)
-
Computer System Validation Package
The package did exceed my expectations. It package has
helped me create a CSV system for a company. CSV is an overwhelming
concept to begin with, so the primer with step-by-step implementation
was great to help determine a starting point. Many
packages offer direction without specific SOPs, this package goes above
and beyond by offering example SOPs, templates, and plans and the primer
to help implement the system. I would *highly* recommend this
package to anyone who needs to start a CSV system or even review their
current CSV system. The checklists are very valuable tools for making
sure that your CSV system will hold up to any audit.
Ms Alecia Oswald, Manager Information Systems,
LVT inc, USA (Ref 1048)
-
ISO 17025 Accreditation Package with
Ludwig Huber
Feedback: The package did exceed my expectations. It gives us a HUGE
head start on the lab start up. The cost is minimal compared to the
return. EXCELLENT documentation. Mr. Russell Hensel, President, Hensel
Environmental Biology Laboratories, USA (Ref 1048)
-
ISO 17025 Accreditation Package,
with Ludwig Huber
Feedback: The package did exceed my expectations. The ISO Accreditation
Package, was very helpful on the start-up of our laboratory especially
on our documentation system. It is a complete package. The necessary
requirements for ISO accreditation are there. Ms Rona Canilao, Trans
World Trading Co, Chief Chemist, Chemical Department, Philippines (Ref 1086)
- Audio seminar: Ludwig Huber,
Validation and Use of Excel in Regulated Environments,
Feedback: The seminar did exceed my
expectations
The presentation provided the details needed for us to set up a
system to do spreadsheet validation. I thought the speaker had a
very effective voice for this type of Webinar format. Ludwig
kept our attention throughout the seminar. I believe this is one
of the best webinars that I have participated in. This was very
valuable to us. We appreciate the opportunity to participate.
Thanks! (Ref 1072)
Dr. Murray Rosenthal, Manager
Reagent Technology Department, Alfa Wassermann Diagnostic
Technologies, USA
- Audio seminar Ludwig
Huber:
Validation and Use of Excel in Regulated Environments,
The seminar did exceed my expectations
I knew little of this subject prior to the webinar, but now I
think I possess the knowledge and tools I need. I think it is also
significant that Dr. Huber's work is cited in FDA LIB 4317!
We GREATLY appreciate all the documents we were able to download (Ref
1073)
Brian Lane, Booz Allen Hamilton/Centers for Disease Control and
Prevention (CDC), Laboratory Quality Management Program, USA
- Audio Seminar
with Ludwig Huber:
Cost Effective Software and Computer System
Validation
Ludwig Huber
Feedback: The seminar provided valuable information on how to proceed
with validation activities in a manner that does not 'break the bank.'
The information on FDA's and other agencies' current thinking will help
narrow the scope of our validation activities. The templates and other
reference materials will help us consolidate and streamline our current
validation practices. (Ref 1001)
Steve Bonin, MEDTOX Laboratories, Inc.
-
Computer System Validation Package,
with Ludwig Huber
Feedback:
The package did exceed my expectations. It has more than enough of what
we need to meet regulatory regulations. Very well put together (Ref
1002)
Michael Brooks, AIT Laboratories, Quality Assurance, USA
-
Computer System Validation Package,
with Ludwig Huber
The package did exceed my expectations. Very detailed. Good
information. All gathered in one place. Examples and SOP documents very
valuable. (Ref 1074)
Michael Delancy, Quality Systems Engineer, Mylan Pharmaceuticals, USA
- Feedback Audio Seminar
with Ludwig Huber:
Validation and Use of
Excel in Regulated Environments
The seminar did exceed my expectations.
I found this to be extremely useful as to the requirements around this
topic. This gave me a great idea on where to begin the process of
validating spreadsheets. Excellent use of my time.
Brian Howard, MNI, IT, USA
- Audio Seminar
Ludwig Huber:
Residual Solvent Analysis
According to USP 467.
Feedback:
The seminar did exceed my expectations.
The speaker explained very clearly how to approach the drastic change
from OVI to residual solvents. Also clearly explained what FDA
expectations are of NDA and ANDA submissions. Great material and slides.
I like the fact that the speaker talks and doesn't merely read the
slides.(Ref 1003)
Donald Johnson, Pii, Analytical services, USA
- Feedback
Audio/Web seminars in general with
Ludwig Huber
I have attended many of your seminars, and I enjoy each one. You provide
more detail and finer points than other people who have longer seminars.
I intend to continue taking your webinars in the future. Thank you
again, very much, for your help!
Connie Curts, Notocord Inc, Contractor, Validation Department, USA (Ref 1004)
- Audio Seminar:
Analytical Instrument Qualification
according to USP 1058
Feedback:
The seminar did exceed my expectations. It was a very good presentation,
with a clear message and good material. It worked very well with
webinar.(Ref 1005)
Viveca Frising, AstraZeneca R&D, Analytical Development, Sweden
-
ISO 17025 Accreditation Package,
with Ludwig Huber
Feedback:
The ISO17025 is a comprehensive resource for all your accreditation
needs. Explanations of key points of the accreditation process are well
explained and there is extensive supporting material (SOP's etc) to
allow an organization to successfully speed along the implementation
process. SOP's and Forms are well written and satisfy the principal
components of ISO17025 guidelines. Access to the website provides a
source to access any updates to documentation. (Ref 1017)
Dr. Andrew Wotherspoon, National Research Council, Bioanalytical
Chemistry, Canada
-
ISO 17025 Accreditation Package
Feedback: The templates were very useful in starting from the ground
floor. Everything really fits together. Website is very helpful. The
package did exceed my expectations.
Kellie Sorrell, Metrology Solutions Inc., Quality Department, Country,
USA (Ref 1013)
-
ISO 17025 Accreditation Package,
with Ludwig Huber
Feedback: The package did exceed my expectations. The number of
documents especially dealing with the IT side of use in Lab environment
exceed what I was expecting for the purchase. I wish a couple years ago
I knew of this website and access. I do know that I will recommend this
to others.
Peggy Weber; Accelerated Technology Laboratories (ATL); USA,
Project Manager (Ref 1020)
- Feedback Audio Seminar:
Effective Training Practices
for FDA Compliance
The seminar did exceed my expectations. The examples were great and the
clear interpretation of the FDA requirements was very helpful. I would
definitely attend another. (Ref 1006)
Nicole St. Croix-Young, GeneNews Corporation Department, Quality
Assurance, Canada
- Audio Seminar
with Ludwig Huber:
Understanding the New USP <1058> for Analytical
Instrument Qualification.
Feedback:
Although my company has rigorous SOPs for the topic of equipment
qualification it was very beneficial to hear another view on the topic
especially with the USP 1058 in mind. As such Dr Huber gave a very good
presentation and combined with the available documentation enables me to
review our SOPs to update them with 1058 in mind. Seminar was very
enjoyable and pitched at the correct level
Dave Stevenson, Charles
River, United Kingdom (Ref 1007)
- Audio Seminar:
Validation and Use of Excel Spreadsheets in Regulated
Environments
Feedback: I used excel throughout graduate school. I needed a guide to
implement excel as a routine tool in my QA Lab. Excellent Seminar. Will
definitely recommend to my peers. (Ref 1008)
Raymond Velez, Cooper Vision, USA, Puerto Rico
- Audio Seminar:
Cost Effective Software and Computer System
Validation
Feedback: We are evaluating 2-3 different automated systems this year.
The seminar provided timely information on the current trends of CSV and
brought to light the key differences between GAMP4 and GAMP5. Reviewing
ways to reduce validation testing was a plus.
I definitely enjoyed it and look forward to reading through the
reference material.
The seminar did exceed my expectations. (Ref 1009)
Juan Turner, Pharmachem Technologies, QA, Bahamas
- Two day workshop
with Ludwig Huber:
Qualification of Instruments and Validation of
Systems in Laboratories
Feedback: The wonderful speaking on workshop and patient answers have
left deep impress upon me. The references must be useful to my
work. Thank you very much once again. Hope to attend your workshop next
time! (Ref 1010)
Xueyun Zhang, Dalian Elite Analytical Instruments Co., Ltd., China
- Audio Seminar :
Validation of Existing/Legacy Computer Systems
Feedback: Many presentations regurgitate the same common sense
approaches to validation. This seminar gave a practical step by step
approach, excellent references, and simple templates. This was my first
LC seminar, and it was well worth the cost. I look forward to more. The
seminar did exceed my expectations. (Ref 1011)
Robert Maddock, Forest Research Institute, PRD LOA, USA
- Audio Seminar:
Validation of Existing/Legacy Computer Systems
Feedback: I didn't think you'd be able to successfully cover as much
as you did in one hour. There was much I did not know but thought I
knew. The seminar did exceed my expectations. Will definitely sign up
for an other. (Ref 1012)
Ken Woychesko, Tanis Technical Inc., Validation Department, Canada
- Conference Presentation: Method Validation Requirements from the USP
and FDA Impact on Pharmaceutical Analysis
Feedback: The topics presented in the conference were up to the mark and
all speakers were experts from their fields. This conference provided us
an opportunity to personally meet world renowned Speaker Dr. Ludwig
Huber whose literature and notes as published on the website I have been
reading from the start of my career. It was
excellent (Ref 1014)
Amee Kanuga, Veeda Clinical Research, QA, India
- Audio Seminar:
Effective Training Practices for FDA
Compliance,
Feedback: We already have a good understanding of training requirements
in the regulated environment. The presentation has provided us with
clear summary, gave proper focus and perspective. It will be very
helpful in revising our existing SOP.
The seminar was informative and well timed with breaks for
interactivity. All subjects were relevant.
Agata Wodzynska .CANTEST Ltd., Human Potential Department, Canada
- Audio Seminar
with Ludwig Huber:
Planning for Computer Systems
Contingency and Disaster Recovery
Feedback Mr Huber seemed to me very well versed on the subject. I was
grateful for the detail in the presentation. I enjoyed also that he
broke down who or what departments may take responsibility for various
processes of the plan responsibilities. Looking forward to the next
seminar
Brian Howell, Teva Pharmaceuticals, Quality Technical Services
Department, USA
- Audio Seminar:
Residual Solvents
According to USP 467
Feedback: The seminar was excellent and exceeded my expectations. An
unambiguous answer was provided about the ''non obligation' to use the
specified USP method for manufacturer of excipient. The remark of
benzene in toluene was excellent. You carefully select areas where the
attendee can read or go deeper by himself at a later time in order to
cover as much as possible. Also you took the time to answer verbally to
the question I have sent 2 weeks ago. You stay on top of new stuff ! Ms.
Michel Boisvert, Anachemia, Canada Inc (Ref 1018)
- Audio Seminar:
Master Planning for
Software and Computer Validation
Feedback: The seminar was excellent and exceeded my expectations. I
expected an overview of a Master Plan for computer system validation. I
got that plus more. The included documents and references were very
helpful. The format of the seminar was good. I appreciated having the
transcript of the seminar as a companion document.
This seminar and the Labcompliance web site have been very helpful. I
was overwhelmed, knowing that I needed to generate many documents but
not knowing where or how to start. Now I can get started. Your current
list is so extensive!.
Mr. Andy Young, Celerus Diagnostics. Engineering Department, USA (Ref 1019)
- Audio Seminar
with Ludwig Huber:
Effective Gap Analysis
for 17025
Feedback: Excellent materials and expertise from speaker, but too
limited time to present all the material Very valuable for my
professional growth.
Mr. Samuel Barrera, BMS, QC/QA; PR, USA (Ref 2021)
- Audio Seminar
with Ludwig Huber:
Auditing Computer Systems
Feedback: I needed more QA perspective to complement my IT and
Scientific audit perspectives, and I received more perspectives than I
had imagined..This excellent seminar is provides many insights to avoid
pitfalls and to enhance quality assurance The seminar did exceed my
expectations.
Connie Curts, Notocord Inc, Contractor, Validation Department, USA (Ref 1023)
- Audio Seminar
with Ludwig Huber:
Validation of Existing/Legacy Computer Systems
Feedback: You present the information in a very clear and concise way.
To the point with little fluff. The seminar did exceed my
expectations.
Mark Buechler, Paracor Medical, Inc., Operations Department, USA (Ref
1024)
- Audio Seminar
with Ludwig Huber:
Validation and Use of Excel Spreadsheets in Regulated Environments
Feedback: The information provided was eye opening. I was unaware that
validating was such an easy process or that there was a reliable way to
do it. Very Informative. Thank you so much!
Ms.Jenny Lesinski, Advion BioSciences, Inc., IT, USA (Ref 1025)
- Audio Seminar
with Ludwig Huber:
Management and
Validation of Computers for ISO 17025
Feedback: All questions/concerns that I had before attending the seminar
were addressed during the presentation. The seminar was very informative.
Ms.Eleanor Britten, Quality Manager, Director's Office, NVSL, USA
(T-1026)
-
Computer System Validation Package
with Ludwig Huber
Feedback: The package clearly stated how to do the CSV..
The package did exceed my expectations.
Mr. Suwardi Bambang Irawan Syah, Technical Services, Idaman Pharma Mfg
Sdn Bhd,, Malaysia (Ref T-1027)
-
Computer System Validation Package,Ludwig
Huber
Feedback: Comprehensive coverage of topics, excellent examples.
Mr. Jim Dougherty, Sr. Mgr. Software Iron Mountain, IT Software
Engineering, Engineering, USA,Ref: T-1028
-
ISO 17025 Accreditation Package.
Ludwig Huber
Feedback: The procedure for each clause specified in the ISO 17025 has
been clearly identified and documented through SOPs.
The package did exceed my expectations
Ms.Kathryn Wadle, Technician, Texas Engineering Exp. Station, Energy
Systems Lab (ESL), USA (Ref T-1029)
-
ISO 17025 Accreditation Package,
Ludwig Huber
Feedback: The package was a good starting point for our ISO17025
compliance program. It ensured that we did not overlook key
requirements, and saved a lot of time in providing a framework to build
on. The ISO 17025 Accreditation Package download from Labcompliance gave
us a head start in our ISO17025 compliance program and significantly
decreased the resources required.
Ms. Brad Whisson, Managing Director, West Minerals Analysis Pty Ltd,
Australia
(Ref T-1030)
-
ISO 17025 Accreditation Package,
Ludwig Huber
Feedback: Documents were thorough and self explanatory. Great
Resource!! I would definately recommend
The package did exceed my expectations
Ms.Tiffany Weldin, Quality Systems Director, Primex Farms, LLC, Quality
Department
USA (Ref T-1031)
-
Computer System Validation Package,Ludwig
Huber
Feedback: Comprehensive coverage with examples. Well structured and
broken down into manageable pieces. Aligns and supports the most
rigorous examples we have encountered and also demonstrates the
inadequacies of less rigorous examples we have seen, helping us to guide
our customers. This package is a must have starting point for anyone
tasked with insuring a credible software validation effort. Worth many
times the price.
The package did exceed my expectations.
Mr. Lawrence DeHeer, President, Blaze Systems Corporation, USA (Ref
1032)
-
Two day seminar: Equipment Calibration and Qualification in
Laboratories
with Ludwig Huber
Feedback: I am in charge of QA and QC, your lecture is very helpful for
QA and QC to carry out the validation and calibration. Perfect lecture
and your good personality gave us a lot of help, thank you for your
help. Hope we can meet again.
The seminar did exceed my expectations.
Ms.Sixin Bi, Vice General Manager for Quality Department, CSPC Zhongnuo
Pharmaceutical Pharmaceutical Co., Ltd., Shijiazhuang, China (Ref
T-1033)
-
Two day seminar: Equipment Calibration and Qualification in
Laboratories
with Ludwig Huber
Feedback: The classification of instrument can help
user to decide what qualification document needed for the instrument.
Very interesting and active to stimulate the students to participate in
discussion and through doing exercises to grasp what you presented in
class. Well-done, very good and I like the class pattern very much.
Every one in class is involved in class content and nobody is bored.
The seminar did exceed my expectations.
Lijun Ji, China CSPC Hebei Huarong Pharmaceutical Co., Ltd., QA&
Regulatory Affairs
China (Ref T-1034)
-
Two day seminar: Practical Computer System Validation and Part 11
Compliance in Laboratories; with Ludwig
Huber
Feedback: The presentation is very practical. It is a guidance for my
work. The presentation cleared many confusions about validation of the
HPLCs.And Dr.Huber has answered my questions clearly after returning
back from Peking by email. I am preparing the inspection. so It is very
useful for me.
The seminar did exceed my expectations.
Mr. Li Jinhong, General Manager Assistant, CSPC NBP Pharmaceutical Co.
Ltd., International Regulatory Affairs, China (Ref T-1035)
-
Two day seminar: Practical Computer System Validation and Part 11
Compliance in Laboratories, with Ludwig
Huber
Feedback: The seminar provided specific and practical methods to perform
computer system validation and equipment qualification. It is helpful to
make the laboratories in my company comply with FDA's requirements. It
was excellent and helpful
The seminar did exceed my expectations.
Ms. Zhou Yaxin, Quality Manager, CSPC Zhongrun Pharmaceutical , China
(Ref T-1036)
- Audio Seminar
with Ludwig Huber:
FDA Compliant Qualification and Performance Testing of HPLC Systems
Feedback: The presented slides outlined all aspects of the current
requirements to the HPLC qualification. The presenter demonstrated great
knowledge in the topic during the presentation and Q&A session.
The seminar did exceed my expectations.
Dr. Beatrisa Aronchik, QA Manager Affymax, QC department, USA (Ref T-1037)
- Audio Seminar:
Stability Testing in Pharmaceutical and API
Industry
Feedback: This is what I expected. I needed to have a clear overview in
a short time.it was very comprehensive.
The seminar did exceed my expectations.
Kevin Breesch, QA Manager Toxicon Europe, QAU, Belgium (Ref T-1054)
- Audio Seminar
with Ludwig Huber:
Learning from Recent FDA Warning Letters Related to Computer
Systems and Part 11
Feedback:
The seminar did exceed my expectations. Lots of
examples given which helped me understand where the focus of the
inspectors lies. Excellent seminar. Mark Elsley, Novo
Nordisk, Head of Data Management Department , Sweden
, Belgium (Ref T-1053)
- Audio Seminar
with Ludwig Huber:
Computer System Validation: Step-by-Step
Feedback:
The seminar did exceed my expectations. We are
preparing for our first FDA audit as our Clinical Research Department
has just finished doing clinical trials for a customer who is now going
to market with a new drug. Part of this will require an FDA audit of our
LAB.
About 60 persons in our lab representing all
departments attended and all were impressed on the great amount of
information that was conveyed in such a short period. The perfect
overview of FDA requirements for our company, Ms. Brian Flaherty,
Spectra Laboratories, Sr Technical Writer,
IT, USA (Ref T-1052).
-
Audio Seminar:
Computer System Validation: Step-by-Step
Feedback:
The seminar did exceed my expectations. The
seminar provided a comprehensive discussion of Computer System
Validation principles, Thanks Ludwig..I've never been disappointed
with one of your seminars. Mr. Larry Gayleard, LG Consulting Services,
QA Consultant, USA (Ref T-1051)
- 2-Day seminar:
Validation and Part 11 Compliance
of
Computer Systems and Data
Feedback:
The seminar was excellent.
The seminar did exceed my expectations.
Information is as per current regulatory guidance
and included data integrity and Part 11 very well. . Dr..
Bhavil Kumar Norola, Sun Pharma, Senior Manager Technical
Training Academy, India (Ref T-2137).
- 2-Day seminar:
Validation and Part 11 Compliance
of
Computer Systems and Data
Feedback:
The seminar was excellent.
Current regulatory requirements have been expliained
in a way that they ere easy to understand. .
.Ms. Neeta Sant, Sai Life Sciences, Asst.General
Manager, QA, India, India (Ref T-2136).
- 2-Day seminar:
Validation and Part 11 Compliance
of
Computer Systems and Data
Feedback:
The seminar was very informative.
It
contained many real life scenarios and challenges that I used to face
. . Mr. Shashank Pandey, Zydus Cadilla, IT
Validation and Compliance, Corporate Quality Control, India
(Ref T-2135).
- 2-Day seminar:
Validation and Part 11 Compliance
of
Computer Systems and Data
Feedback:
The seminar was a great learning for me in 2 days and it has cleared
many questions I had about overall validation and about about
21CFRPART11 and data integrity. The step by step approach helped to
understand the validation process.
Mr. Santosh Pawaskar, Emerson, Manager, PSS Department, India
(Ref T-2134).
- 2-Day seminar:
Validation and Part 11 Compliance
of
Computer Systems and Data
Feedback:
The seminar did exceed my expectation.
All areas were covered although briefly but
nicely. The presentation was excellent and also the
presenter's good interaction with all participants.
Mr.
Koushik Rajaram, Aris Pharma,
Head Quality, Quality Department, India (Ref T-2133).
- 2-Day seminar:
Validation and Part 11 Compliance
of
Computer Systems and Data
Feedback:
I
got good knowledge about working profile of mine and future prospects.
and also got clarifications of general mistakes which should be avoided
in future. Mr.
Umesh Rajani, Sun Pharma, Computer System Validation, IT-CSV
department, India (Ref T-2132).
- 2-Day seminar:
Validation and Part 11 Compliance
of
Computer Systems and Data
Feedback:
The seminar was excellent and it did exceed my expectations,
It was very useful and I got all my quires clarified,
Mr.Himanshu Shekhar, Pathak,
Astrazeneca Pharma, Validation Lead, Technical
services Department India (Ref T-2131).
- 2-Day seminar:
Validation and Part 11 Compliance
of
Computer Systems and Data
Feedback:
The seminar did exceed my expectations, It was a great one to
start with definitive examples. It was was worth the time spent and the
knowledge gained.
The seminar had practical examples on how to manage a computer system in
a regulated environment with definitive answers to critical systems
management. Mr.Sridhar Kulkarni,
Dr. Reddy's Laboratories, Manager, QA Department, India (Ref T-2130).
- 2-Day seminar:
Validation and Part 11 Compliance
of
Computer Systems and Data
Feedback:
The seminar did exceed my expectations.
It was helpful as I got to know what are regulatory requirement for
Validation. Dr. Ludwig Huber was extremely knowledgeable and supportive.
He replied to all questions even during breaks and after the seminar.
.Mr. Ulhas Nadekar, Sciformix Technologies Pvt.Ltd,
Quality manager, Pharmacovigilance department, India (Ref T-2129)
- 2-Day seminar:
Validation and Part 11 Compliance
of
Computer Systems and Data
Feedback: Seminar was very informative and
it did meet the expectations.
The seminar came with good, informative study material .
All queries were sorted out. Thank you Dr. Ludwig Huber.
.Mr. Ashwini Kulkarni, Emcure Pharmaceuticals Ltd, Senior
Executive, Quality Assurance Department, India (Ref T-2128)
- 2-Day seminar:
Validation and Part 11 Compliance
of
Computer Systems and Data
Feedback: Seminar was very informative and
it did exceed
my expectations.
It was was extremely helpful and it gave me the knowledge about
what Regulatory Authorities expectations are. Dr. Ludwig Huber was
extremely knowledgeable and responded to all queries which I had
.Mr. Midhun RaJ K Nadekar, Sciformix Technologies Pvt.Ltd,
Senior quality specialist, Pharmacovigilance department,,
India (Ref T-2127)
- 2-Day seminar:
Validation and Part 11 Compliance
of
Computer Systems and Data
Feedback:
The seminar did exceed my expectations.The
seminar gave me insight right from the basic concepts to the advance
level which will help in correcting / directing initiatives to achieve
compliance . Dr.Huber is definitly a Super Subject matter expert and he
communicates the topics very effectively . Mr.
Shibin
Chulliparambil,
Cipla Limited,
Head IT, India (Ref T-2126).
- 2-Day seminar:
Validation and Part 11 Compliance
of
Computer Systems and Data
Feedback:
The seminar
did exceed
my expectations.
I
got better clarity and understanding of validation and part 11
compliance of computer system and data .Mr, Avadhut
Patil, Polypeptide, Executive Quality Control, India (Ref T-2125)
- 2-Day seminar:
Validation and Part 11 Compliance
of
Computer Systems and Data
Feedback:
The seminar was thoroughly
informative and it was explained beautifully such that despite being
from a non-IT background, I could understand the topic well enough. The
seminar covered important topics and I especially liked the way in which
the compliance topics were explained using examples of FDA warning
letters .The seminar was very well conducted and was
on-time. There were no unnecessary delays. Ms. Divya
Krishnakumar, ACG Associated Capsules Pvt. Ltd, Sr. Executive, Central
Quality Assurance Department,. India
(Ref T-2124)
- 2-Day seminar:
Validation and Part 11 Compliance
of
Computer Systems and Data
Feedback:
The seminar was very
helpful. It helped me to be updated with the regulatory requirements for
the industry. I was especially interested in the data integrity topic.
Topics covered on e-signatures and audit trails was most of interest..
Ms. Neva Sahant, ACG Associated Capsules Pvt. Ltd, Sr. Executive,
Regulatory Affairs Department, india (Ref T-2123)
- 2-Day seminar:
Validation and Part 11 Compliance
of
Computer Systems and Data
Feedback:
The seminar did exceed my
expectations.
It was very informative and
discussion with Dr. Huber were very much interactive.
, Mr Sanjiv Sharma, Panacea Biotec, AGM, QA Department,
india (Ref T-2122)
- 2-Day seminar:
Validation and Part 11 Compliance
of
Computer Systems and Data
Feedback:
The seminar was excellent and it
did exceed my expectations.
It included nice and excellent presentations on Computer
System Validation. It did clarify all queries related to CSV and also
provided important tips for another points like Network qualification,
Cloud qualification etc. Mr. Rahul Jain,
Lambda Therapeutic, Assistant General Manage, BioAnalytical
department, India (Ref T-2121)
-
Audio Seminar:
Effective Training Practices for FDA Compliance
Feedback:
The seminar did exceed my expectations. The
seminar gives on a platter about the requirement, what happens if you do
not follow (warning letters) and a clearly laid procedure how to develop
an effective training program. The excellent material did exceed
my expectations. Ms. Nilanjana Basu, Lupin Limited, DMG-Technical
Training, CQA, India (Ref T-1050).
-
Audio Seminar:
Validation and Use of Excel® Spreadsheets in Regulated
Environments
Feedback:
The seminar provided great information specific to the topic and nice
Q&A session at the end.
There were lots of good downloads of
examples and procedures available as supporting material,
Dr. Amanda Stennett, Fresenius Medical Care NA,
Research Chemical Engineer, Corporate Research, USA
(Ref T-1049).
-
Audio Seminar:
Validation and Use of Excel® Spreadsheets in Regulated
Environments
Feedback:
The seminar did exceed my expectations. Dr.
Huber clearly knew his subject and communicated precisely what is needed
to meet regualations. Great seminar. Ms. Janet Kingsley, WL Gore and
Associates, Clinical Reseach, USA (Ref T-1047).
- Audio Seminar
with Ludwig Huber:
FDA's New Enforcement of 21 CFR Part 11
Feedback:
The seminar did exceed my expectations. The
presentation was clear concise and to the point. The program presented a
common sense and accurate approach to Part 11 compliance. A good level
of detail and examples was presented.
Information will be used soon.
Thank You. Mr. Michael Piacenza,
Linde, Medical & FDA Compliance Mgr, USA (Ref T-1046).
- Audio Seminar with Ludwig
Huber:
FDA's New Enforcement of 21 CFR Part 11
Feedback:
The seminar did exceed my expectations.
OUTSTANDING CONTENT. Each slide
has important and significant details. M. Huber's comments added and
excellent examples, had excellent explanations to ensure the information
was clearly understood, and had extra information to enhance and deepen
the understand. Much value added
to the slides. The usage of colors Red vs. Black on slides 29 and 30 is
VERY helpful. Colors give me confidence I can review slides one year
from now and correctly understand what the slide is comparing and which
items belong to which category of information compared. Inclusion of EU
information increasingly important to me, because most of my clientele
are now in European and Asian countries. All my EU questions were
answered. The seminar showed me at least 2 more ways to further
enhance Part 11 compliance.
Although GMP was the focus, GLP was included, and put into good
perspective.
Connie Curts, Regulatory Affairs and Validation Consultant,
Associated with Notocord, USA ( (Ref T-1045).
- Audio Seminar
with Ludwig Huber:
FDA's New Enforcement of 21 CFR Part 11
Feedback:
The seminar did exceed my expectations.
Good and clear presentation, links, references, examples. Excellent, I
will recommend my co-workers to participate
Dr. Vladimir Veselov, Cordis - Johnson and Johnson, Principal Scientist,
USA (Ref T-1044).
-
Audio Seminar:
Validation and Use of Excel® Spreadsheets in Regulated
Environments
Feedback:
The seminar did exceed my expectations.
Because it achieved the purpose described. It provided very good
references and it was very clearly presented. I liked this seminar
because it did not have hidden information, or implied information. The
information was very objective and useful.
It was noticeable that Dr. Huber was knowledgeable, thank you for having
experts presenting. Ms. Aurelia Estela Rascon, CareFusion, Supervisor of
Scientific Research Department, USA (Ref T-1043.
-
Audio Seminar:
Validation and Use of Excel® Spreadsheets in Regulated
Environments
Feedback:
The seminar did exceed my expectations. Dr.
Ludwig Huber gave very practical, real world advice and suggestions.
Having access to download the S.O.P.'s and documents on the spot was a
huge plus. I really enjoyed the sharing of materials. This is something
that can help right now.
Ms. Andrea Hands, WL Gore & Associates,Inc, , Testing and Validation
Analyst, USA (Ref T-1042).
-
Audio Seminar:
Validation and Use of Excel® Spreadsheets in Regulated
Environments
Feedback:
The seminar did exceed my expectations. Dr.
Ludwig Huber gave very practical, real world advice and suggestions.
Having access to download the S.O.P.'s and documents on the spot was a
huge plus. I really enjoyed the sharing of materials. This is something
that can help right now. I have no further recommendations as I felt
this was one of the best web seminars I have attended
Ms. Andrea Hands, WL Gore & Associates, Inc, , Testing and Validation
Analyst, USA (Ref T-1041).
-
Audio Seminar:
Validation and Use of Excel® Spreadsheets in Regulated
Environments
Feedback:
The seminar did exceed my expectations.
Excellent knowledge and a lot covered in the hour. Very good seminar.
Dr. Ron Kneisler, Albermarle Corporation, QA Advisor, Quality
Department, USA (Ref T-1040).
-
Audio Seminar:
Validation and Use of Excel® Spreadsheets in Regulated
Environments
Feedback:
This was exactly the kind of start off
information we were looking for. We are just beginning to consider
validation of Excel spreadsheets. Very good information. Really liked
the references so we can see where to pursue additional guidance.
Mr. Damon Talley, SAFC, QA Supervisor, QA, USA (Ref T-1039).
-
Audio Seminar:
Validation and Use of Excel® Spreadsheets in Regulated
Environments
Feedback:
The seminar did exceed my expectations. Dr.
Huber did not just provide high level information but practical real
world advice on methods to use to meet spirit of regulations
Ms. Dionne Boyce, WL Gore & Associates, Inc, , Validation Analyst, USA (Ref T-1038).
-
Macro and Spreadsheet Quality
Package
Feedback: The package did exceed my expectations..The set of
documentation covers the entire scope of Excel spreadsheet utilization
in a regulated environment (either in the binder or the CDROM). Well
done ! Totally professional !!. (Ref 1060)
Mr. Michael Capel, IT Director of Stryker, France.
-
Audio Seminar:
Recent Warning Letters and 483's Related to Computer Validation
and Part 11
Feedback:
The seminar did exceed my expectations. Dr.
Huber knows exactly what the FDA is expecting. Very concrete
recommendations and good examples. Very good seminar and well organized.
Mr. Joachim Fehr, Stryker, CSV Specialist QA, Germany (Ref T-1076).
-
Audio Seminar:
FDA's New Enforcement of 21 CFR Part 11
Feedback:
The seminar did meet my expectations. I always
expect a wonderful seminar from Dr. Huber, and my expectations were once
again met. A great time saver for me as I do not have time to look up
recent 483s relating to Part 11 -- worth the time and cost.
Ms. Diana Mayes, Manager of ABC Laboratories, USA (Ref T-1077).
-
Audio Seminar:
FDA's New Enforcement of 21 CFR Part 11
Feedback:
The seminar did
exceed my expectations. Webinar was
very informative to our current practice and will help us focus and
stream line our process. I would recommend this seminar to everyone
having the same responsibilities.
Mr. Mike Robertson, QA Engineer at Energizer, USA (Ref T-1078).
-
Computer System Validation Package,
with Ludwig Huber
Feedback:
Material provided was able to reinforce my knowledge of computer system
validation and add practical examples. Material provided was a great
introduction and hands on tool for me
Mr. Steve Krueger, Owner, MAK and Associates,, USA (Ref T-1079).
-
Laboratory Compliance
Package,Ludwig Huber
Feedback:
span>
The package helped us pursue
our target. The documents were jumpstart
procedures for us to implement. More and more corporates must
start utilising Mr.Hubers resources as a training methods for clear
understanding of his concepts
Mr. VenkideshRamadoss, VP Quality Control, Caplin Point Labs.Ltd., Chennai, India (Ref T-1080).).
- Audio Seminar
with Ludwig Huber:
Understanding and Preparing for FDA's New Part 11 Inspection
Programstrong>
Feedback:
The seminar did
exceed my expectations.
Very informative presentation, and clearly presented .
Dr Huber does an excellent presentation, well developed, and very
informative, as usual.
Mr. John Egoville, Teva
Pharmaceuticals, Senior Compliance Auditor, Computer
Validation Group Country USA (Ref T-1081).
- Audio Seminar:
Understanding and Preparing for FDA's New Part 11 Inspection Program
Feedback:
The seminar did
exceed my expectations.
The presentation contains much more pertinent information than I had
expected. As mentioned above, the seminar is very useful
as it contains a lot of information.
Mr. Lucian Hirtiee,
Labstat International ULC QS Manager, Canada
(Ref T-1082).
-
Audio Seminar:
Learning
from Recent FDA Warning Letters Related to Computer Validation and Part
11
Feedback:
I basically wanted a overview of
what the FDA is looking for and this webinar fit my needs exactly. I
thought the presentation of the material was done very well, DR Huber is
obviously knowledgeable and he presented the subject matter very
clearly.
Mr. Gene Rideout, Instrumentation
laboratory, Software Quality assurance, R&D, USA (Ref T-1083).
- Audio Seminar:
Understanding and Preparing for FDA's New Part 11 Inspection Program
Feedback:
The seminar did
exceed my expectations.
Dr. Huber did a very good job going in detail of this topic.
Great Seminar.
Ms.
Kimberly Stark,
Nspirehealth,
Director QA/RA, USA
(Ref T-1084).
- Audio
Seminar with Ludwig Huber:
How to Efficiently Build a GLP Laboratory
Feedback:
The seminar was very well done, provided a lot of
useful information, and made me think about a lot of things I hadn't
already thought of. My todo list definitely grew as a result of the
seminar (which is a good thing). Overall, the seminar
was very helpful to me, and actually I have referred back to it on two
different occasions, and I reviewed the slides even more. Thank you
Ms. Sandra Boehm, Wisconsin National Primate Research
Center, Compliance Coordinator, QA Department(Ref T-1087).
- Full Day Web Seminar:
Design and Validation of Excel
Spreadsheets: Step-by-Step
Feedback:
The seminar did exceed my expectations. The
instructor was clear with his presentation and gave detailed
information. I found this webinar very useful and
interesting.
Ms. Lisa Quinones, Kyowa Hakko Kirin Pharma, Inc.,
Sr.Admin Assistant, QA Department, USA
(Ref T-1088).
- Audio Seminar:
Latest Compliance Updates for Computer Systems
Feedback:
We used the information in the
audio Seminar and the attached documents to create 7 Computer Validation
SOPS. The audio Seminar provided good value for our money.
Thank You, we will order again in the future.
Mr. Carlos Pereira, Cangene
Corporation Computer Validation Coordinator, Canada
(Ref T-1089).
- Audio Seminar:
Understanding FDA's 21 CFR Part 11
Feedback:
The seminar did exceed my expectations. It very
clearly explained what to think about and how to go about meeting your
company's compliance to this guidance. Ludwig Huber is clearly very
qualified to led this discussion. I received the
information I was hoping to get from this seminar. I really appreciated
all of the reference
material available until Feb 28,
Ms. Laura Roberts,
Sunrise Medical ,
Sr Manager Regulatory Affairs
USA
(Ref T-1090).
- Audio Seminar:
Understanding and Implementing the New EU Annex 11
Feedback:
The seminar did exceed my expectations. Very
clear description of the requirements.
Good examples from practice.
Good references. Very good seminar. Recommendation to visit.
Mr.
Joachim Fehr, Stryker Leibinger GmbH&Co, CSV
Specialist / DPO CSV, QA / CSV Department,
Germany
(Ref T-1091).
- Audio Seminar:
Understanding FDA's 21 CFR Part 11
Feedback:
The seminar did exceed my expectations. I found
the reference material to be extremely helpful. I feel this
seminar was accurate, concise, and very well organized..
Ms.
Jennifer Eagan, Cyanta Analytical Services,
Associate Director of QA Department, USA
(Ref T-1092).
- Two day seminar:
Validation and Part 11 Compliance of Computer Systems
Feedback:
The seminar did exceed my expectations.
Fundamentals of computer validation nicely explained.
Also how to use common sense in Validation became more clearer.
Dr. Ludwig has a good
control on the subject.
Mr.
Kalpeshkumar Vaghela, CEO,
Infra Control Systems,
India (Ref T-2110)
- Two day seminar:
Validation and Part 11 Compliance of Computer Systems
Feedback:
The seminar did exceed my expectations. Contents
of the seminar were very good and based on these we have listed out 35
procedures to be prepared to cope up with 21CFR guidelines. And our
existing SOP & master plan needs to be revised to include
more points. It was excellent and myself learned lot of
new things related to my filed. Thanks to Dr. Huber and Global
compliance Panel.
Mr.
Tejpal Amonkar, Sr. Executive,
IT Department,
Ratiopharm
India Pvt. Lt., A
Teva Group,
Company, Verna-Goa,
India
(Ref T-2109)
- Two day seminar:
Validation and Part 11 Compliance of Computer Systems
Feedback:
The seminar did exceed my expectations.
Very useful tool, to implement the concept as per
current regulatory norms .
Mr.
R. Shaik Mohamed Noor, Sr.
Manager,
Quality Control, Shasun,
India
(Ref T-2108.
- Two day seminar:
Validation and Part 11 Compliance of Computer Systems
Feedback:
Great value addition
to the information on the IT compliance in GxP
environment . Excellent coaching on
IT compliance.
Mr.
Nandan
Thakur,
CSV. Manager,
IT Compliance, TCS,
India
(Ref T-2107).
Audio Seminar:
IT Infrastructure and Network Qualification: Step-by-Step
Feedback:
I'm new to the GxP IT world. The seminar was
useful. I quickly gained an overview of network qualification.
I would recommend the seminar to other IT professsionals.
Mr. Carmelo Rodriges, Amicus Therapeutics,
Director Information TechnologyDepartment, USA, USA
(Ref T-1105).
- Audio Seminar:
Transfer of Analytical Procedures According to the New USP Chapter
<1224>
Feedback:
The seminar did exceed my expectations. We were
looking for some information to evaluate transfer requirements when an
analytical method is transferred between our QC - Analytical Development
and QC - Operations groups. This seminar gave a wealth of information
about the subject and provided many options and examples that will help
in our evaluation. The subject matter was provided in an
easy to follow format and was well presented. Overall, the speaker was
very knowledgeable of the subject and a lot of good information was
conveyed.
Mr. Ben Crosby Rodriges,
Kremers Urban Pharmaceuticals, Supervisor Analytical Development, USA,
(Ref T-1146).
Audio Seminar:
Infrastructure and Network Qualification: Step-by-Step
Feedback:
The seminar did exceed my expectations. It was a
very good seminar and I learn more from it than from the published
guides on the topic
Mr. Francois
Njieha,
, Kwelong, Inc.,
CSV Engineer, USA
(Ref T-1111)..
Audio Seminar:
IT Infrastructure and Network Qualification: Step-by-Step
Feedback:
The seminar did exceed my expectations. All parts
of networks and infrastructure that I remember were clearly addressed.
Thank you and congratulations!
Mr.
Paulo Marques, Bial,
IT/IS
Quality Assurance,
Portugal
(T-1112).
Audio Seminar:
Validation and Use of Cloud Computing in FDA Regulated Environments
Feedback:
The seminar did exceed my expectations. Content
was solid and associated materials are very helpful. The presentation
covered a broad range of relevent topics.
Dr. Huber certainly knows his subject.
Dr. Teri Stokes,
GXP International, Director, USA (Ref T-1168).
Audio Seminar:
Validation and Use of Cloud Computing in FDA Regulated Environments
Feedback:
The seminar did meet my
expectations. Excellent overview and touched on the many esoteric issues
that need to be considered. Generally well done
(excellent organization, pacing).
Mr. Mr. Don Hurd, The
Realtime Group, VP Quality, USA
(Ref T-1161).
Audio Seminar:
Validation and Use of Cloud Computing in FDA Regulated Environments
Feedback:
The seminar did exceed my expectations. It was a
very good seminar and I learn more from it than from the published
guides on the topic
Mr. Jeff Wiser, Independant consultant,
USA
(Ref T-1159).
Audio Seminar:
Validation and Use of Cloud Computing in FDA Regulated Environments
Feedback:
The seminar did exceed my expectations. The NIST
definitions were new to me and were helpful in providing technical
understanding. Seminar contained the information that I
was looking for and more.
Ms. Monika Roschlaub, Invensys
Regulatory Compliance, Principal Consultant,USA (Ref T-1145).
Audio Seminar:
Validation and Use of Cloud Computing in FDA Regulated Environments
Feedback:
The seminar did exceed my expectations. The
presenter knew the topic very well, didn't just repeat what was on the
slides. The flow of the presentation was excellent. Nice technical
overview with smooth transition to regulatory requirements.
Great seminar. I look forward to attending another one in the near
future.
Mr. David Fraser, 3M, QA Department,
USA
(Ref T-1141).
Audio Seminar:
Validation and Use of Cloud Computing in FDA Regulated Environments
Feedback:
The seminar did exceed my expectations. Very
straight forward responses with Yes or No answers to qestions.
This may have been the best use of a training hour that I had in several
years..
Jerome Sauve, GE Healthcare, IT Compliance,
USA
(Ref T-1140).
- A
udio Seminar:
Comparing GLP with GMP
Feedback:
The presentation was very informative. I enjoyed
the table layout. The visual made it easy to follow and use later for
reference. This was very insightful
Erica Schnars,
BioAgilytix Labs,
QA,
Corporate Compliance Manager ,
USA
(Ref T-1171).