The QSR (21 CFR 820): What each subpart really requires

Website https://compliance2go.com/product/?pid=CP2014-397 | Edit Freely

Category Medical Device

Deadline: November 19, 2014 | Date: November 19, 2014

Venue/Country: Houston, U.S.A

Updated: 2014-10-29 15:56:11 (GMT+9)

Call For Papers - CFP

The QSR regulations - with the exception of 820.30 Design Controls - have not changed significantly over the last several decades. However, the interpretation of each subpart has been shaped and updated with new FDA insight into critical quality processes. Learn about key FDA focus areas in each subpart, how to prevent the most common 483 and warning letter observations and how to establish a lean compliance system within your company. Get tips from an expert in remediation who has helped Fortune 500 medical device companies through risk management, design control, DHF and process validation remediation activities.

Why should you attend :

The QSR is examined and practical advice is discussed using case studies, 483 and warning letter text and a practical approach to implementing quality improvements and alignment to FDA quality system requirements.

Areas Covered in the Session:

21 CFR 820 (Subpart A - Subpart O)

Who will benefit: (Titles)

Engineers

Vice Presidents

Directors

Quality Professionals

Compliance Staff and Officers

Consultants

CEOs

Anyone Interested in the Topic

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

60 Minutes Live Presentation

Certificate