Usa 2016 Conference on 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. Now a new commissioner vows no more "business as usual". Data in submissions and decisions rendered will be more science-based and subjected to greater scrutiny. 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

Speaker Profile:

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.

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: support@compliance4All.com

http://www.compliance4all.com/

Event Link : http://bit.ly/2aa1m9B

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