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
On-line Audio Seminar 107
Successful FDA Inspections
Preparation - Conduct - Follow Up
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
- 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
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
- 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
- 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
- FDA inspections - preparation, conduct, follow up
- Change control of software and computer systems
- Gap analysis/check lists
- Good laboratory practices
- Good Manufacturing practices
- 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
- And more....
Who should attend?
- QA managers and personnel
- Analysts and lab managers
- Validation specialists
- Regulatory affairs
- Training department
- Documentation department
How to order
Pick one of the options in the table that fits your needs.
Replaced by the more recent seminar
to Successful FDA GMP Inspections
With Tool Kits
for Preparation, Conduct and Follow-up
About audio seminars
Online audio seminars are presented over the
phone. During the live presentation attendees can:
- Study the printed slide material
- Watch the slides on a computer
- Watch the slides on a video screen in a seminar room
- 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
||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,