What Firms Should Do to Best Prepare for and Manage Audits by EU Notified Body and FDA

Website https://compliance2go.com/product/?pid=CP2014-430 | Edit Freely

Category Pharmaceutical

Deadline: March 31, 2015 | Date: March 31, 2015

Venue/Country: Online, U.S.A

Updated: 2015-03-03 18:04:22 (GMT+9)

Call For Papers - CFP

This webinar is intended to help you get familiar with regulatory audits by the US Food and Drug Administration and EU Notified Bodies.

This webinar is further intended to help you understand what you can do to best prepare for and manage the audits by EU Notified Bodies and FDA with increased awareness.

The FDA enforcement actions have recently increased. In EU, EU commission issued recommendation concerning unannounced audits by notified bodies in medical device industry.

As a medical device firm, you are subject to regulatory audits or inspection by the US FDA and EU notified body if you bring your medical device products into the US and EU countries allowing CE-marked products.

This webinar will cover the details of how you can proactively prepare for and manage the audits.

Why Should you Attend

To learn how to adequately prepare for and manage regulatory audits by the US FDA and EU notified bodies.

Areas Covered in the Webinar

Statutes and Regulations in US and EU

Definitions

EU Unannounced Audits

Comparative Overview of both ISO 13485 and 21 CFR Part 820

Understanding Auditing Strategy

Audit Objectives and Process

How to Audit Quality Management Systems

Various Audit Approaches

Quality Systems and Subsystems in ISO 13485

Quality Systems and Subsystems under 21 CFR Part 820

FDA and ISO 13485

Communication during Audit or Inspection: Dos and Don’ts

Good Practices: Speaker’s Suggestions and Recommendations

Conclusion

Who will Benefit

Regulatory Affairs

Quality Professionals

R&D

Complaint And Risk Management Personnel

Consultants

Contractors/Subcontractors

CEOs

VPs

Clinical Affairs

Other Interested Parties

Webinar Includes:

Q/A Session with the Expert to ask your question

Copy of PowerPoint slides (PDF print only)

60 Minutes Live Presentation

Certificate of Attendance