Why Medical Device Companies Receive Warning Letters - Webinar by GlobalCompliancePanel 2010
September 21 - 28, 2010(Ended)
Online Webinar
The Commissioner of the US FDA has stated the agency will be more
enforcement oriented and quicker to issue Warning Letters. This
presentation will review current enforcement practices of the US FDA
with actual Warning Letters recently issued to medical device
companies. We will explore how the company failed to meet FDA
expectations in response to inspection and other violations. In the
presentation we will attempt to determine what response by the
manufacturer may have prevented the issuance of the Warning Letter. We
will look at improvements to the Quality System as well as responses to
the FDA-483 that was issued to the manufacturer following the
inspection. The presentation will show techniques that may be used with
publically available information to follow FDA`s current practices and
predict how the manufacturer may act to avoid a Warning Letter.
Why Should You Attend:In the medical device world, the US FDA has become more aggressive in enforcement of the regulations for manufacturers and others. The FDA has stated they will be quicker to issue Warning Letters to device companies, and evidence shows that is the case.
Areas Covered in the Session:
- How to Access FDA Warning Letters
- Actual Warning Letters and what they mean
- Why a manufacturer got a Warning Letter
- How the manufacturer could avoid a Warning Letter
- Interpreting FDA`s current Enforcement posture from Warning Letters
- Reviewing a manufacturer`s regulatory position
- Preparing for a visit by FDA
Who Will Benefit:
- Quality Managers
- Regulatory Managers
- Internal Auditors
- Quality Engineers
- Regulatory Associates
- Management Representatives
Prices *
245 US Dollar (Early registration date: September 20, 2010)
Exhibition
No exhibition
Organization
Categories
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Important
Please, check the conference website for possible changes, before you make any traveling
arrangements
* Prices are for evaluation only.
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