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FDA BEST AUDIT PRACTICES DOS AND DONTS

Charles H. Paul

Friday,
May 03,2024
Time:
1:00 PM EDT
Duration:
90 Minutes
Event Type :
Live Webinar
Category:
Pharmaceutical
Days Left :
Today
Overview :

This webinar will begin by discussing and emphasizing the importance of
truthfulness to the process – truthfulness in performing the job on a daily
basis, truthfulness in completing the regulatory documentation that is so much a
part of our regulatory lives, and finally in the context of this webinar,
truthfulness when interacting with FDA inspectors.

A key component of this webinar is the discussion of the tricks and techniques
that inspectors use to elicit information. How you react and respond when they
occur could impact your results.
Other key communication skills will be presented in the context of the
inspection and interpersonal exchanges between inspectors and company associates
being questioned.

We will complete the webinar by discussing how to handle, at the moment, adverse
findings as they are identified by the inspector so as to not compound the
issues and severity of the findings.

Areas Covered:-

 * Importance of truthfulness
 * Importance of knowledgeability and confidence
 * FDA Tricks to Elicit Information
 * Arguing and challenging
 * Behavior during the inspection
 * Importance and role of documentation
 * Effective communication skills
 * Being deceptive
 * Opinion versus fact
 * Phrases never to say
 * Handling adverse findings during the inspection

Background:-

The FDA has been increasing its surveillance of regulated industries. While it
is a given that companies must meet their regulatory requirements, how company
staff handle an audit and interact with FDA inspectors, can mean the difference
between a successful and an unsuccessful FDA audit. The cost of an ineffective
interaction can be staggering.

Why Should You Attend:-

If you are in any regulated business - pharmaceuticals, or medical devices, you
will experience an inspection by the U.S. Food and Drug Administration (FDA).
According to the Food, Drug, and Cosmetic Act, “Registered domestic drug
establishments shall be inspected by the FDA at least once every two years.”
Depending upon the inspection type and the circumstance, inspections may occur
more frequently.

The outcome of those inspections can have a grave significant impact on your
business even if you and your colleagues have done everything “right.” How you
and others behave and interact with FDA inspectors can have an impact on the
results reported. Interacting with inspectors is not a natural behavior,
effective techniques must be learned and mastered if those inspections are to
have positive outcomes.

Who Will Benefit:-

This is an all-inclusive webinar benefiting all individuals within the
organization particularly those in positions of management and supervision.

 * Vice Presidents
 * Directors
 * Associate Directors
 * Managers and Supervisors in ALL functions will benefit from this
   organization.

Significantly, compliance and regulatory who spearhead the inspections and are
responsible for compliance readiness, as well as training that should be
building on-going training around this subject should also be included.


LIVE VERSION

$199 Live




$499 Corporate Live 1-3-Attendees




$899 Corporate Live 1-6-Attendees


RECORDED VERSION

$199 Recording




$199 Transcript




$209 DVD


COMBO VERSION

$379 Live & Recording




$379 Recording & Transcript

Refund Policy

* Download the Order Form

* For 6+ attendees call us at + 1 (866) 755-8624 or mail us at
cs@onlineaudioeducator.com

FIND MORE PHARMACEUTICAL WEBINARS

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Instructor:





Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory,
training, and technical documentation consulting firm. Charles has been a
regulatory consultant to the life sciences industry for over 20 years and has
published numerous white papers on the subject. The firm works with both
domestic and international clients designing solutions for complex human
performance and compliance-related problems.



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