Conference Description:

In FDA-regulated industries, it is imperative that firms should be well aware of and understand the laws and regulations governing FDA-regulated medical products (e.g., food, drugs, biologics, cosmetics, and medical devices including in vitro diagnostics). In particular, it is important to recognize policy changes and risk-based, strategic regulatory and compliance approaches (best practices) under the new administration.

Areas Covered in the Session :

>. Laws and regulations
>. New administration
>. FDA policy
>. FDA enforcement
>. Risk-based approaches
>. Industry misconceptions
>. FDA inspection preparation and management

Who Should Attend:

>. CEOs
>. VPs
>. Compliance officers
>. Attorneys
>. Regulatory Affairs Departments
>. Clinical Affairs Departments
>. Quality Assurance Departments
>. R&D Departments
>. Consultants
>. Contractors/Subcontractors