Audio Seminars

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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) George Smith: CDER Update on Part 11 Inspection Assignments (June 2011)

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

4) 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
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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 364

FDA's New Enforcement of Part 11

Learn what the FDA is looking for and how to respond

Recorded, available with all reference material at any time

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FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. And while Part 11 has not been changed since 1997 and requirements are well known, the interpretation of individual inspectors with new types of warning letter citations makes preparation for inspections so difficult. So the industry has many questions.   :

Key Questions related to FDA's New Part 11 Inspections

  • Is 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 ?
  • How to demonstrate data integrity and security?
  • Do 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 do always look at? 
  • Is there a standard inspection questionnaire?
  • What are the recommendations for clinical record systems?
  • How do the new inspections impact Medical Device manufacturers?
  • How should we prepare our department for inspections?
  • Do we need new SOPs?
  • How can we fix most critical Part 11 issues short term?
  • Is enforcement discretion still applied and if yes for which requirements?
  • Do other countries have a similar program?
  • Are there additional requirements from the new EU/PICS Annex 11?

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 Part 11 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 Part 11 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
  • FDA's current inspection and enforcement practices
  • FDA's new interpretation: learning from FDA inspection reports
  • Strategy for cost-effective implementation of Part 11: A six step plan
  • Recommended changes to existing Part 11 programs to reduce costs
  • Justification and documentation for the FDA and your management
  • Going through case studies from laboratories, offices and manufacturing with graphical workflow of records, step-by-step description, recommendations for individual Part 11 requirements with justifications and documentation for the FDA and your management.
  • Case studies how to avoid or respond to Part 11 related observations with corrective actions to fix current issues and preventive actions to prevent reoccurrence of the same or similar issues.
  • How to prepare your company for Part 11 Inspections

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

  • PowerPoint Presentation
  • Script
  • Part 11 Compliance Master Plan
  • Part 11: Step-by-step Implementation
  • Six example SOPs:
    - 21 CFR Part 11: Scope and Controls
    - FDA Inspections: Preparation, conduct, follow up
    - Electronic Audit Trail: Specifications, Implementation, Validation
    - Review of electronic audit trail
    - Retention and Archiving of Electronic Records
    - Manual reintegration of chromatographic peaks
  • 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
    - 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

Recorded seminar, available at any time with all reference material

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.  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)

  2. 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).
  3. 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).
  4. 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).
  5. 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)