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 243

Understanding FDA's 21 CFR Part 11

Introduction and Strategies and Tools for Implementation

Recorded

In 1997 the US FDA issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). Even the rule is more than 10 years old there still many questions related to the scope and real requirements of Part 11.

Questions are:

• For which computer systems does Part 11 apply?
• What are the key Part 11 requirements?
• Which requirements are enforced and which ones not?
• What are the main inspection issues?
• FDA requires to base Part 11 implementation on risk assessment: What does this mean? What are the minimal documentation requirements?
• What does limited and authorized access really mean?
• Which types of procedures are required?
• When is electronic audit trail a 'must'?
• How to archive raw data: paper vs. electronic records
• How to deal with existing systems? What are minimum requirements?
• How to develop and implement a gap analysis and remediation plan?
• What if Part 11 functionality is not available for my system?
• Where to get reference material (gap analysis, examples, worksheets, SOPs) for easy implementation?
• Our supplier offers a Part 11 compliant computer system, why should I care?

How does the on-line 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 give practical recommendations. After the seminar, an extensive list of reference material like SOPs, gap analysis, implementation plan templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn:

• Overview on Part 11 history and requirements
• Current and future FDA inspections with focus on computers and electronic records
• Part 11 requirements that are NOT enforced any more
• Going through individual requirements: validation, limited authorized access to system and data, archiving and retrieval of e-records, executing electronic signatures  binding signatures with records, training
• Recommendations for implementation and documentation
• Bringing existing systems into compliance with minimal effort
• Responsibilities of vendors and users
• Going through most common pitfalls
• Going through frequently asked questions and answers

Get 10+ Documents To Do it Right The First Time:
download 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
• Gap analysis/checklist: 21 CFR Part 11
• Templates/examples
  - Requirement Specifications for Part 11
  - Most frequently asked questions and answers
• 15 Case Studies for Part 11 Implementation
  - All well documented with graphical workflow, step-by-step description, recommendations for Part 11 requirements and justifications for the FDA and your management
• Case studies on how to avoid and respond to Part 11 related 483s and Warning Letters
• Example: Letter to the FDA about Electronic Signature Certification
• Example: Statement on Accountability for Electronic Signatures
• 20+ Warning letters and Inspectional observations related to 21 CFR Part11, all from 2006-2010
• FDA/EU Guidance documents related to electronic records/signatures and computer validation

Who should attend?

• Everybody using computers in FDA regulated environment?
• 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, 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.-
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.