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 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 Twitter Follow us ? https://twitter.com/compliance4all Facebook Like us ? https://www.facebook.com/Compliance4all Pinterest - https://in.pinterest.com/compliance4all/
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