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.

On-line Audio Seminar 230

FDA's New Enforcement of 21 CFR Part 11

Strategies and Tools to implement FDA's New E-records&Signatures Directions

 Recorded

FDA's new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations. Just in 2007/2009, there have been about 30 Warning Letters related to Part 11 compliance, some with disastrous consequences for inspected companies. It seems that 'enforcement discretion' as stated in the 2003 guidance is not applied any more. FDA's computer expert John Murray recommended at a conference to follow 21 CFR Part 820 also for drug companies. So there are many questions: 

Key Questions related to Part 11 are:

• What are the must Part 11 requirements as of today?
• Which ones will stay, which ones will go away?
• What document should we follow: Part 11, the Part guidance or is there anything else?
• What can we lean from FDA Warning Letters?
• Which systems should comply with Part 11?
• When is electronic audit trail a 'must'?
• How to develop and implement a gap analysis and remediation plan?
• What is FDA's current thinking and enforcement strategy?
• How to document risk assessment for Part 11
• How does FDA's enforcement practice compare with the new EU Annex 11?
• Where to get reference material (gap analysis, examples, worksheets, SOPs) for easy implementation?

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 present strategies and an overview and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, test scripts, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

• FDA's current inspection and enforcement practices
• FDA's new interpretation: learning from FDA guidance, and recent FDA conference presentations and discussions
• Learning from FDA inspection reports
• Part 11 and the new EU Annex 11: similarity and differences
• Strategy for cost-effective implementation of the 'new' 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
• 15 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.
• Preparing for Part 11 Inspections

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

• Part 11 Compliance Master Plan
  - Ideal to develop or update your company's Part 11 program
• Part 11: Step-by-step implementation
• SOPs:
  - Define and Document Scope and Controls for Part 11
  - Electronic Audit Trail: Specifications, Implementation, Validation
  - Training for GxP and Part 11
  - Retention and Archiving of Electronic Records
  - Recording of GMP Raw Data
  - Risk based Validation of Computer Systems
• Gap analysis/checklist: 21 CFR Part 11
• Templates/examples
  - Requirement Specifications for Part 11
  - Most frequently asked questions and answers
• 15 Case Studies
  - All well documented with graphical workflow, step-by-step description, recommendations for Part 11 requirements and justifications for the FDA and your management
• 20+ Warning letters and Inspectional observations related to 21 CFR Part11, all from 2006-2009
• FDA Presentation with Edwin Rivera: Data Interity and Fraud - Another Looming Crisis
  This presentation and related back-up information triggered FDA's new enforcement Practices for Part 11
• FDA Presentation with Part11 Update
  George Smith, US FDA, Member of FDA's Part11 Task Force, Presented in April 2007
• FDA/EU Guidance documents related to electronic records/signatures and computer validation

Who should attend?

• Part 11 groups in Bio(pharmaceutical) and device industry
• System owners
• Software developers
• IT managers and system administrators
• QA managers and personnel
• Analysts and lab managers
• Validation professionals
• Training departments
• Documentation department
• Consultants

Date, time and duration

Order at any time, replay 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.-
Recorded seminar - CD Get the CD in your mail Order includes all reference material.	US$ 399.-
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.-

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 author of the Labcompliance Newsletter. He has been conducting over 100 web and audio or video based seminars since ten years. He is worldwide director for FDA compliance at Agilent Technologies.

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 visits FDA in Rockville, VA, and participates in panel discussions with FDA professionals. For more information, click here.