Starting with Design Control, and progressing into production, testing and release. Change control of each Device Master Record is mandatory to allow meaningful hazard analysis/risk management, product validations, CAPA/P&PC, product/system continuous improvement. It prevents waste of limited company resources (personnel, budget, time). Change control ensures that documentation reviewed years later correctly reflects how product was designed, produced, tested, and released years earlier. Essential to prove a company’s due diligence, and minimize liability. Without change control, there is no quality system!
Areas Covered in the seminar:
Who Will Benefit:
John E. Lincoln, consultant, has successfully designed, written and run all types of qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control projects; with over 24 years of experience, primarily in the medical device industry.
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