Usa 2016 webinar on Change Control - The Achilles Heel of cGMP Compliance

Overview:

The last few years have seen an increase in product recalls. For this and other reasons, the U.S. FDA come under increasing negative public scrutiny.

High profile drug recalls, food chain problems and contamination, import problems, resignations. Â Now a new commissioner vows no more "business as usual". Â Data in submissions and decisions rendered will be more science-based and subjected to greater scrutiny. Â Failure to comply will result in more and faster Warning Letter filings.

Areas Covered in the Session:

Change Control - what it is; what it is not
Areas impacted by Change Control
Regulatory / FDA 483 "Hot Buttons"
Design control
Document Control
Identifying changes
Preventing negative changes
Maintain a 'state of control'
Business needs and obtaining 'bur-in'

Who Will Benefit:

Senior management, project leaders, internal / external consultants
Mid-level management and supervisory personnel
Corporate and site coordinators
Regulatory affairs
Quality systems personnel / QAE
Document Control
R&D and engineering staff
Purchasing personnel
New product development personnel

Contact Detail:

Compliance4All DBA NetZealous
Phone: +1-800-447-9407
Email: [email protected]
http://www.compliance4all.com/
Event Link : http://bit.ly/2aa1m9B
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Speaker and Presenter Information

John E Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.