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 166

Learning from Laboratory Related Warning Letter

Learn from Mistakes Others Made and How to Avoid Them

Recorded

Analytical laboratories are considered high risk systems. Typically they perform the last control step before products are released. Therefore laboratory systems are on the radar screen of FDA and other inspections. Laboratories are most frequently inspected and the number of warning letters and 483 inspection observations rank before production and distribution systems. Laboratories are unsure on how to avoid warning letters.

Key questions related to laboratory warning letters are

• What are inspectors looking for during inspections?
• What are most frequently found deviations?
• There are so many warning letters letters on the internet, how can I find the ones related to laboratories?
• 483s are hardly published on the Internet, where can I find them?
• Establishment inspections reports (EIR) are like FDA inspection protocols and very useful, where can I find them?
• How can I avoid 483's and warning letters?
• What can we do to reduce damage after we received a 483 or warning letter?

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 typical and representative examples of 483s, EIRs and Warning Letters with deviations related to laboratory work. Each example will be followed by detailed recommendations on how to avoid them. After the seminar, an extensive list of reference material like SOPs and templates will help to develop and implement procedures to avoid FDA observations and Warning Letters. .

During the interactive presentation you learn about:

• FDA enforcement practices - 483's vs. EIR and Warning letters
• Finding the laboratory FDA warning letters, EIRs and 483s
• Typical warning letters, EIRs and 483s related to laboratories
• Warning letter examples through all laboratory activities
• How to interpret FDA deviation reports
• How to avoid warning letters and 483s
• Responding to 483s
• Responding to warning letters

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

• Laboratory compliance master plan
• With 50+ pages advice on how to build compliance into laboratories
• SOPs:
  - SOP: FDA Inspections: Preparation, conduct, follow-up
  - SOP: International Inspections: Preparation, conduct, follow up
  - SOP: Auditing Analytical Laboratories
• Templates/Examples
  - Laboratory audit checklist
• Reference paper:
  How to avoid FDA warning letters
• 20 typical original FDA 483s/EIRs/Warning letters with deviations related to all laboratory operations.
  Includes deviations related to sampling, sample transfer, equipment, computer and method validation, testing, records, OOS, facilities and stability testing
• FDA Presentations (include statistics and examples for warning letters)
  - FDA Perspective on Laboratory Inspections with, Yvonne McKnight, US FDA
  - Laboratory GMPs and Inspectional Issues: an FDA Perspective, T.Savage, US FDA
• FDA Guides
  - Foreign inspection guide
  - Inspection of pharmaceutical QC labs
  - Drug manufacturing inspections guide
• PIC/S Guide
  - Inspection of Pharmaceutical Quality Control Laboratories
• And more....

Who should attend?

• QA managers and personnel
• Analysts and lab managers
• Validation specialists
• Regulatory affairs
• Training department
• Documentation dep
• Consultants

How to order

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

Recorded seminar - Web download 'Site' offer 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$ 349.-
Recorded seminar - CD Get the CD in your mail Order includes all reference material.	US$ 349.-
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$ 249.-

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.