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.

On-line Audio Seminar 260

Learning from Recent Warning Letters Related to Good Laboratory Practices

For Preparation of FDA and International GLP Inspections

Recorded, available with the reference material at any time

The number of FDA warning letters issued by the FDA has been increasing over the last couple of  years, especially in the area of Good Laboratory Practice regulations. Warning letters and 483's are ideal tools to prepare an organization for FDA inspections. They are useful to learn what inspectors are asking and what mistakes other companies make so you can avoid them. While FDA regulations and even guidance documents don't change for long time, FDA inspection practices do. And since they have to be approved by FDA management they do not express the opinion of single inspectors but FDA's current thinking. They are much more up-to-date than regulations and FDA guidelines. And even though most FDA warning letters are publicly available on the FDA website, it is difficult to find the ones relevant to GLP regulation and to assess the impact on your GLP study.

Key Questions related to GLP and Warning Letters are:

• What is FDA's most current thinking related to GLP?
• What are the current inspection trends?
• What are most frequent recent citations related to FDA's GLP regulation?
• How to avoid FDA 483 Inspectional observations?
• How to best respond to 483's to avoid warning letters?
• Are there proven tools that help to implement GLP strategies?

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 examples and recommendations on how to avoid FDA warning letters and 483's. 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 GLP 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
• The meaning of GLP warning letters and 483 inspectional observations
• Examples of recent GLP related 483’s and Warning Letters
• Most obvious reasons for deviations
• Proven practices to avoid FDA 483's
• Responding to 483's to avoid warning letters: going through case studies
• Writing corrective and preventive action plans as follow up to 483's
• Strategies and tools for compliant GLP implementation
• The future of GLP inspections

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

• Six example SOPs:
  - FDA Inspections: Preparation, Conduct, Follow-up
  - Retention and Archiving of Electronic Records
  - Recording of GLP Raw Data
  - Historical SOP File for GLP Regulations
  - Archiving GLP Data and Other Documents
  - Handling and Reporting of GLP Study Deviations
• Checklists:
  - Good Laboratory Practice Regulations
  - Laboratory Audits
• Case Studies
  - How to avoid GLP related 483's and Warning Letters
  - How to respond to GLP related 483's and Warning Letters
• 10 warning letters and Inspectional observations with typical deviations related to Good Laboratory Practice regulations
• FDA Compliance Manual for Inspectors: Good Laboratory Practice (Nonclinical Studies)
• SOP for EMA GLP Inspection
• Good Laboratory Practices and Current Good Manufacturing Practices: 120 pages primer (2.3 Mbytes)

Who should attend?

The seminar is a must for everybody involved in GLP studies and related FDA and international inspections

• GLP Lab Personnel, Supervisors and Managers
• QA managers and personnel
• GLP auditors
• Archivists
• IT managers and personnel
• Consultants
• Teachers

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.-

Please forward to your colleagues, just click here

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.