Change Control - Implementation and Management

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:

• CGMP and ISO 13485 requirements
• Involvement in many 483s
• Change control and QSIT
• Major industry problems with Change Control
• SUPAC, Validation, and Technology Transfer Issues
• Preventing negative changes
• Maintain a ’state of control’; Management Review
• Risk Management (per ISO 14971) and Change Control
• When to report to agencies

Who Will Benefit:

• Senior management, project leaders
• Regulatory affairs
• Quality systems personnel
• R&D and engineering staff
• All charged with new product development, regulatory submissions, initiating/overseeing company-wide training, production, validation, and statistical analysis
• CAPA and P&PC personnel desiring to minimize post-production/life cycle and other costly problems.

Instructor Profile:

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.

Follow us :