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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On-line Audio Seminar 263

Learning from Recent Warning Letters Related to GMP Laboratory Controls

For Preparation of FDA and International GMP Laboratory Inspections

Recorded, available with the reference material at any time

Recent FDA statistics  show that laboratory controls are ranked as the top GMP deviations. For example, in 2010 about 20% of GMP deviations were related to laboratory controls. Typically they are considered high risk because they perform the last control step before products are released. 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 warning letters have to be approved by FDA management they do not only express the opinion of single inspectors but FDA's current thinking. They are much more up-to-date than regulations and FDA guidelines. But companies are unsure on how to avoid inspectional deviations.

Key Questions related to Laboratory Controls and Warning Letters are:

• What is FDA's most current thinking related to laboratory controls?
• What are FDA's current inspection trends?
• What are most frequent recent citations related to FDA's GMP laboratory 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 compliant laboratory control strategies?
• How to best prepare our lab for FDA and other GMP inspections?

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 GMP lab 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 GMP warning letters and 483 inspectional observations
• Most frequent observations
• Examples of recent GMP laboratory 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 implementation of compliant laboratory control
• Preparing the laboratory for FDA  and equivalent international GMP inspections

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

• Seven example SOPs:
  - FDA Inspections: Preparation, Conduct, Follow-up
  - International Inspections: Preparation, Conduct, Follow-up
  - Training for Laboratory Personnel
  - Quality Assessment of Laboratory Suppliers
  - Laboratory Failure Investigations
  - Reserve Samples in Laboratories
  - Maintenance of Laboratory Equipment
• Checklists:
  - Laboratory Audits
• 12 Case Studies
  - How to avoid and respond to GMP laboratory related 483's and
     Warning Letters
  - Corrective and preventive actions
• 20+ warning letters and Inspectional observations with typical deviations related to Lab Control Good Manufacturing Practice regulations
• FDA Compliance Manual for Inspectors: Drug Manufacturing Inspections
• FDA statistics on foreign GMP Inspections in  fiscal year 2010 with a comparison to 2009
• FDA Inspections
  - FDA Perspective on Laboratory Inspections
    Yvonne McKnight, US FDA
  - Laboratory GMPs and Inspectional Issues: an FDA Perspective,
    T.Savage, US FDA

Who should attend?

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

• QC Lab Personnel, Supervisors and Managers
• QA managers and personnel
• GMP auditors
• 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.-

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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.