Labcompliance On-line Audio Seminar

On-line Audio Seminar 104

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)

FDA's 21 CFR Part 11

Requirements, New Scope and Recommendations for Implementation

Recorded

In 1997 the United States Food and Drug Administration (FDA) issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. This was done in response to requests from the industry. With this regulation, entitled Rule 21 CFR Part 11, electronic records can be equivalent to paper records 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).

Questions are:

• What are the key requirements?
• What are the issues?
• What is FDA's new scope and current thinking?
• When is electronic audit trail a 'must'?
• How to archive records: paper vs. electronic records?
• How to deal with legacy systems?
• How to develop and implement a gap analysis and remediation plan?
• What is FDA's current thinking and enforcement strategy?
• How to document business practices
• How to document risk assessment for Part 11
• Where to get reference material (gap analysis, examples, worksheets, SOPs) for easy implementation?

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:

• What are the key requirements?
• What are the issues?
• What is FDA's new scope and current thinking?
• When is electronic audit trail a 'must'?
• How to archive records: paper vs. electronic records?
• How to deal with legacy systems?
• How to develop and implement a gap analysis and remediation plan?
• What is FDA's current thinking and enforcement strategy?
• How to document business practices
• How to document risk assessment for the FDA?
• Where to get reference material (gap analysis, examples, worksheets, SOPs) for easy implementation?

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

• SOP: Define and document scope and controls for part 11
• Gap analysis for part 11
• SOPs: GxP and part11 training,
• Remediation plan and schedule
• Paper: 21 CFR Part 11 - Introduction
• Paper: New scope of part 11
• FDA 483 form inspectional observations and several warning letters with deviations related to Part 11
• All old and new FDA guidance documents for Part 11
• And more.

Who should attend?

• IT personnel
• QA managers and personnel
• All developers and users of spreadsheet applications
• Production and lab managers
• Regulatory affairs
• Validation specialists
• Training department
• Documentation department
• Consultants

About Dr. Ludwig Huber

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

He 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.

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.

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 over the phone
5. Ask questions through web forms

Attendees can discuss and ask questions over the phone, fax or e-mail.

The transcript and questions and answers have been be posted at the seminar website. This includes questions that came through e-mail and life during the seminar.

How to order

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

Recorded seminar - Standard (Instant download)
Single person, includes all reference material From the convenience of your desk	US$ 249.-
Recorded seminar - Site offer (instant download)
Multiple persons - single site Meet in a seminar or conference room or share the audio file and reference material at your site	US$ 349.-
CD - Recorded audio seminar
Get the CD in your mail Useful if you can/could not attend the on-line seminar. Order includes all reference material.	US$ 349.-
Recorded Seminar plus reference material - Special offer for Labcompliance User Club Members)
(for user club information and registration, click here)	US$ 149.-

Best Practices

all included in the seminar handout - and more!!!