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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.

On-line Audio Seminar 107

Successful FDA Inspections

Preparation - Conduct - Follow Up

Recorded

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An FDA inspection can be a nightmare that costs your company money, time and reputation, or it can be an opportunity to make a long lasting good impression at the FDA and to improve your quality systems.

Single and multiple 483 Inspectional Observations and Warning Letters can be a disaster for a company. Bad reputation for the company and employees, delay of new product approvals, import alters, products recalls, multi-million $ fees, seizures and consent degrees can be the consequence if not followed up correctly in time. However, 483's and warning letters can be avoided.

Knowing FDA regulations and guidelines help but are not enough. Knowing what FDA inspectors are looking at and knowing enforcement practices and trends are equally important. And when it happened, damage can be minimized by effective and timely response.

Key Questions related to FDA Inspections are:

  • What is FDA's new system inspection process?
  • Which systems are always inspected?
  • What are inspectors looking at within the systems?
  • What are most frequent deviations?
  • How to prepare our staff for an inspection?
  • How to treat an inspector?
  • What to do if I don't agree with the inspector's observations?
  • What documents should be available and what can/should we give or not give to the inspector?
  • How can I avoid 483's and Warning Letters: during the inspection, in the exit meeting, afterwards?

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 strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • Understand the inspection process
  • Understand system inspections versus product inspections
  • How to write an SOP for inspections
  • How to prepare your staff for an FDA inspection
  • How to conduct internal audits in preparation for external inspections
  • What documents should be available and in which form
  • How to treat the inspector
  • Understand what the inspector is looking at
  • Learn how what to do and what not to do and say during inspections
  • Learn what you can do in the exit meeting and when the inspector has left

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

  • SOPs:
    - FDA inspections - preparation, conduct, follow up
    - Change control of software and computer systems
  • Gap analysis/check lists
    - Good laboratory practices
    - Good Manufacturing practices
  • Examples
    - Laboratory audit checklists
    - 483 Form inspection observations
    - Warning letters
    - Establishment inspection reports
  • FDA Guides
    - Foreign inspection guide
    - Inspection of pharmaceutical QC labs
    - Drug manufacturing inspections guide
  • Presentation "Ready for a Computerized System Validation Audit", presentation from David Bergeson, former FDA expert for computer validation.
  • And more....

Who should attend?

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

How to order

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

Replaced by the more recent seminar

Six Steps to Successful FDA GMP Inspections

With Tool Kits for Preparation, Conduct and Follow-up

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.