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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 356

Lessons from Recent Quality Control Lab related FDA Warning Letters

Learn how to use warning letters and 483s to other firms to design compliance into your lab

Recorded, available with all reference material at any time

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Recent FDA statistics  show that laboratory controls are the #2 GMP deviations after procedures. QC laboratories are considered high risk because they perform the last control step before products are released; that's why FDA pays so much attention. 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 interpret and get real useful insight information from Warning Letters and 483 inspectional observations.

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 citations related to QC and Contract Laboratories
  • Why do most warning letters start with deviations related to the quality system?
  • What is the meaning behind some frequently used phrases?
  • How can we use warning letter citations to build our compliance program?
  • How to avoid FDA 483 Inspectional observations?
  • How to best respond to 483's to avoid warning letters?
  • We got a warning letter: how to best respond to avoid further enforcement?
  • Are there proven tools that help implementing 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 inspection process: Preparation, conduct, follow up
  • The meaning of GMP warning letters and 483 inspectional observations
  • Most frequent observations along the sample and data flow
  • Examples of recent top GMP laboratory related 483’s and Warning Letters
  • How to get meaningful compliance advice from Warning Letters
  • Most obvious reasons for inspectional observations
  • Most obvious reasons for warning letters
  • Proven practices to avoid FDA 483's
  • How to avoid warning letters through 483 responses as expected by FDA
  • Writing corrective and preventive action plans as follow-up to 483's
  • Strategies and tools for implementation of compliant laboratory controls
  • Preparing the laboratory through 'FDA inspection like internal audits'
  • Going through case studies

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

  • 32-page Primer, just published in Jan 2015, authored by Ludwig Huber
    Compliance by Design for Pharmaceutical Quality Control Laboratories
    Insight from FDA Warning Letters
  • Five example SOPs:
    - FDA Inspections: Preparation,
    Conduct, Follow-up
    - International Inspections: Preparation, Conduct, Follow-up
    - Responding to FDA 483 Inspectional Observations
    - Responding to FDA Warning Letters
    - Auditing Quality Control Laboratories
  • Checklists:
    -
    Auditing Quality Control Laboratories
    - Pharmaceutical Analytical Laboratory QA Audit
    - Pharmaceutical quality System in Testing Laboratories
  • 10 Case Studies
    - How to avoid and respond to GMP laboratory related 483's and
       Warning Letters
    -
    Examples of root-cause analysis, corrective and preventive actions
  • 20+ warning letters and Inspectional observations with typical deviations related to QC lab inspections
  • FDA Compliance Manual for Inspectors: Drug Manufacturing Inspections
  • FDA Inspections Presentations
    - FDA Perspective on Laboratory Inspections
      Yvonne McKnight, US FDA
    - Laboratory GMPs and Inspectional Issues: an FDA Perspective,
      T.Savage, US FDA

FDA inspection items along the entire sample and data flow

FDA issued citations for all activities in the lab. Attend the seminar to learn what are the most important ones

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

Recorded seminar, available at any time with all reference material

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.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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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 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.

Dr. Ludwig Huber in Panel Discussions with FDA Officials

George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about computer system validation and e-records.
Ludwig Huber (right) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference.
Mr. Murray explined FDA'snext steps for Part 11


Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:
 Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,