Conference Description:

In FDA-regulated industry, it is imperative that firms should be well aware of recent policy changes and understand what laws and regulations apply for FDA-regulated products on the US market (e.g., food, drugs, biologics, cosmetics and medical devices including in vitro diagnostics).

Areas Covered in the Session :

>. Laws and Regulations
>. Recent FDA Policy Changes
>. FDA Inspection Manuals
>. FDA Inspection Types and Depth of Inspection
>. How to Avoid Common Deficiencies
>. Actionable Inspection Preparation and Management
>. Communication with EQ Skills
>. Employee Training
>. Actual Case Studies
>. Speaker’s PASS-IT Suggestions/Recommendations-Dos and Don’ts
>. Conclusion


Who Should Attend:

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