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All documents shown here are included in the seminar for instant download

 

 

1) George Smith: CDER Part 11 Inspection Assignments (July 2010)

2) Edwin Rivera: Data Integrity and Fraud – Another Looming Crisis?

3) Steve Wilson: FDA Regulatory Perspective on Data Integrity

The reference material includes links to FDA and international regulations and guidelines

 

Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here
To share this seminar info with your colleagues, click here

Testimonials

We have received very positive feedback from attendees of this and previous seminars related to Part 11. To learn how the seminar helped to understand and implement Part 11 and to prepare companies for Part 11 inspections, click here.

On-line Audio Seminar 256

How to Prepare Yourself for FDA's New Part 11 Inspection Program

Learn what the FDA is looking for and how to respond

Recorded, available at any time

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Within the next few weeks and months the FDA will conduct a series of Part 11 related inspections. Planned routine inspections will be extended to evaluate the companies' practices to ensure accuracy, integrity, authenticity and availability of electronic records, and the FDA plans additional 'for cause inspections'. Inspections are planned for US but also in foreign countries. The program is the long awaited next step for Part 11 and nevertheless it came as a surprise to the industry. There are many questions about the program and further steps::

Key Questions related to FDA's Part 11 Inspection Program are:

  • How are companies selected for the inspections?
  • Are companies selected based on submissions to the FDA?
  • Are 3rd party service providers part of the program, e.g., CROs?
  • Will there be a list of companies that will be inspected?
  • Will the outcome of inspections be made available to the public, e.g., through warning letters?
  • When exactly will the program start and how long will it last?
  • How many inspections will be part of the program?
  • Could preclinical (GLP) studies be part of the program?
  • Will there be a dedicated Part 11 inspection team?
  • Is the material used to train inspectors available to the the public, and if so how can we get it?
  • Are inspectors trained on what to look at specifically?
  • It seems, that record integrity is a key issue, Is there a standard how records are protected ?
  • Will inspections take longer because of Part 11?
  • Will there be a process to review the inspection reports to ensure consistency?
  • Are there certain things inspectors will always look at? 
  • Will there be a standard inspection questionnaire?
  • What are the recommendations for clinical record systems?
  • How will the program impact inspections of Medical Device manufacturers?
  • Validation is one important requirement, is there a guidance from the FDA?
  • How should we prepare our department for inspections?
  • How can we fix most critical Part 11 issues short term?
  • Is enforcement discretion still applied and if yes for which requirements?
  • What are the most likely Part 11 steps after this program?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, The speaker will give very detailed information on the FDA program and answer all questions above and more. He also will provide information on FDA's expectation how Part 11 requirements should be implemented.. After the seminar, an extensive list of reference material like case studies,  SOPs, checklists and templates will help immediate and cost effective implementation of a Part 11 program that is in line with current and future FDA's expectations. The seminar lasts one hour and will be conducted over the phone and supported by the Internet.

During the interactive presentation you learn about:

  • FDA inspections: Preparation, conducts, follow up
  • Scope of the new Part 11 program: time frame, expected outcome
  • Criteria for selection of target companies
  • What inspectors are looking for
  • How  to prepare your company for the upcoming inspections
  • Learning from previous inspections with focus on Part 11 and computer validation: most frequently cited deviations
  • How to fill gaps short term
  • Developing a program for long term
  • Creating the right documentation to satisfy the inspectors
  • Most likely next steps after the inspection program

And for easy and instant implementation:
download 10+ documents from special seminar website

  • Part 11 Compliance Master Plan
  • Part 11: Step-by-step Implementation
  • Four example SOPs:
    - 21 CFR Part 11: Scope and Controls
    - FDA Inspections: Preparation, conduct, follow up
    - Electronic Audit Trail: Specifications, Implementation, Validation
    - Retention and Archiving of Electronic Records
  • Examples
    - Requirement Specifications: Electronic Audit Trail
    - Part 11 Requirement Specifications
  • Checklists
    - Part 11 Compliance
    - Using Computers in FDA Regulated Environments
  • Case Studies
    - Implementing Part 11 (15 examples for pharma, devices and clinical studies)
    - How to avoid Part 11 related 483's and Warning Letters
    - How to respond to Part 11 related 483's and Warning Letters
  • Warning Letters and Inspectional Observations with typical deviations related to computer validation and Part 11 compliance
  • Publications
    -:Risk based validation of software and computer systems
  • FDA Presentations:
    - George Smith: CDER Part 11 Inspection Assignments (July 2010)
    - Edwin Rivera: Data Integrity and Fraud - Another Looming Crisis?
    - Steve Wilson: FDA Regulatory Perspective on Data Integrity

Who should attend?

  • Everybody using computers in FDA regulated environments
  • IT manager and staff
  • QA managers and personnel
  • Regulatory affairs
  • Training departments
  • Consultants
  • Validation specialists

Date, time and duration

Order at any time, replay at any time, download the reference material at any time.

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download

  • Multiple persons - single site
  • Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site.
  • Order includes all reference material.

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members
Recorded Seminar- CD or Web download.

  • Order includes all reference material.
  • for Usersclub information and registration, click here

US$ 299.-
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George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about computer system validation and e-records.
Ludwig Huber (right) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference.
Mr. Murray explined FDA'snext steps for Part 11


Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:
 Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,

About audio seminars

Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP® Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.

Testimonials/References

 

 

The Feedbacks on the seminar has been received by e-mails. Labcompliance has permission to use the testimonials as references. Original e-mails are stored in the Labcompliance archive.

  1. Seminar: Understanding and Preparing for FDA's New Part 11 Inspection Program
    Feedback: The seminar did exceed my expectations.  The seminar is very useful as it contains a lot of information.
    Mr. Lucian Hirtie,  QS Manager, Labstat International ULC, Canada
    (Ref T-1082).
  2. Seminar: Understanding and Preparing for FDA's New Part 11 Inspection Program
    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,  Senior Compliance Auditor,  Computer Validation Group, TEVA Pharmaceuticals, USA
    (Ref T-1081)

  3. Seminar: Recent Warning Letters and 483's Related to Computer Validation and Part 11
    Feedback: The seminar did exceed my expectations.  The presentation contains much more pertinent information than I had expected.
    Mr. Joachim Fehr, Stryker, CSV Specialist QA, Germany
    (Ref T-1076).
  4. 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).
  5. Seminar: FDA's New Enforcement of 21 CFR Part 11
    Feedback: The seminar 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.
    Ms. Mike Robertson, QA Engineer at Energizer, USA
    (Ref T-1078).