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
