Preparing for and Passing an FDA Inspection: A-Z
Strategies, tactics, hints and tips to guarantee
a cost-effective first-time pass through an FDA inspection
On this page...
Benefits of attending for
you and your company
At the end of the course you will... |
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understand the mechanics and extent of an FDA inspection |
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be fully aware of FDA’s risk management and
quality systems approaches to GMP compliance |
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realize how FDA’s 21st century GMP initiatives
have changed the inspection landscape |
| • |
know how to prepare yourself and your company for
an inspection |
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recognize the traps and pitfalls facing you in an
inspection |
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know why you pass or fail an inspection in the first
fifteen minutes |
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understand why you absolutely cannot afford to fail
an FDA inspection |
Who Should Attend
Senior management who will deal with FDA inspectors,
regulatory affairs professionals and quality assurance
personnel.
Production, engineering, validation, quality control
and research and development staff who will be facing
an FDA inspector will find this seminar essential
preparation and key to the company’s success
at the inspection.
Course Language
The course is presented in English
Course Overview
The world of GMP compliance has dramatically changed
with FDA stressing pre-approval inspections, risk
management, investigations and CAPA, quality systems
approaches, and process and analytical technology
(PAT) applications.
If you last passed an FDA inspection more than four
years ago, or if you have never faced an FDA inspection,
you will be unprepared for FDA’s 21st-century
inspection methods. This course provides all the background
information and key techniques needed to guarantee
a cost-effective, first-time pass through an FDA inspection
– whether for a pharmaceutical product, an active
pharmaceutical ingredient (API), a medical device
or a biological product.
All API, medical device, diagnostic product manufacturer,
biotechnology product or pharmaceutical manufacturers
– no matter in which country they operate –
must pass an on-site FDA inspection of their facilities
and operations if products are to be sold in the United
States.
This seminar is designed to provide background and
insight into the inspection process, as well as practical
strategies and tactics that a company must know and
implement in order to have the potential to pass an
inspection the first time through.
The seminar covers everything you need to know —
from the background to the inspection, including the
importance of the commitments made in the product
application (the DMF, the NDA, the BLA or the PMA).
In addition we will discuss the differences between
good science and GMP compliance issues. The inspection
process itself will be analyzed and reviewed in a
manner that will allow you to immediately begin effective
strategizing on how to pass the inspection. Nothing
has been left out. The course touches on everything,
and we do mean everything, you need to know to have
a smooth and successful inspection.
Course Outline
- FDA organization: who does what within FDA
- FDA inspection objectives
- FDA’s 21st-century initiatives and their impact on inspections:
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Quality systems approaches and inspections
- Risk management
- Changes to FDA’s ONDC review process
- Process and analytical technology (PAT)
- Electronic records/electronic signatures (21CFR11)
- The approval process and how inspections are planned and triggered
- The differences between a GMP and a pre-approval inspection (PAI)
- Strategies of companies that have been successful; Lessons from companies that have failed
- Paying for an inspection
- Preparing for an inspection: key elements that must be covered
- Training your company staff
- How to handle an inspector
- Key do’s and don'ts: things that will kill you during an inspection
- What the inspector is looking for in:
- Batch documentation
- Stability studies
- Validation documentation
- FDA's inspection techniques: system inspections explained
- FDA strategies for preparing for rapid inspections
- FDA’s expectations from:
- Your CAPA systems
(Corrective Actions and Preventive Actions)
- Your environmental trending reports
- What documents you need to show the FDA
- Effective investigation of:
- Complaints
- Out-of-specifications, out-of-trends
- Environmental monitoring requirements
- What to say (and what not to say) to an inspector
- The five validation inspections: what FDA looks for in validations
- Bribery, corruption, fraud: how to entertain FDA legitimately
- Documentation requirements: before, during and after the inspection
- Follow-up by FDA after an inspection
- FDA application integrity policy and import alert system
- Follow-up by the company after an inspection
- What to say, and how to say it
-
Rescuing yourself from a marginal inspection
Previous Participant Testimonials
The course on "Passing an FDA
Inspection" was extremely useful, both in your
presentation content and in your response to the attendees'
questions.
Michael Bartlett, GlaxoSmithKline
I just wanted to say what a wonderful course —
I was hooked from start to finish. It's been a real
eye-opener for me. Thank You.
Christine McMullins, Eli Lilly
Thank you for the very informative and enjoyable course
you presented yesterday. I really enjoyed it, and
will certainly be recommending the course to others.
Rosie O’Shea, Celltech-Chiroscience
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