|
Documenting a Risk-Based Quality System - for Compliance and Cost-Savings
Most companies are still utilizing an SOP-based Quality System
Description
How do you set-up the risk basis for subsequent action? How do you create and blend the Risk Management File findings into your Quality Management System (QMS)? How is it maintained throughout the applicable lifecycles?
Most companies are still utilizing an SOP-based Quality System. While SOPs are required, most are structured for a “one-size-fits-all” approach to compliance. However, the US FDA and the EU have repeatedly stated that the majority of quality and regulatory activities are or should be “risk based”. Changing a company’s quality system to a true risk-based system can result in a redistribution of scarce resources to activities that have a higher payoff in terms of reduced liability, both civil and regulatory. How do you set-up the risk basis for subsequent action? How do you create and blend the Risk Management File findings into your Quality Management System (QMS)? How is it maintained throughout the applicable lifecycles?
Areas Covered in the seminar:
- FDA's Q9 and ISO 14971:2001 -- Recent regulatory expectations
- The Master QMS Plan -- A recommended approach
- QSIT for a strategic, systems analysis of the QMS high risk concerns
- How to use your Risk Management Tools (per Q9 and ISO 14971)
- Risk in Design Control, the DHF, and Product Validations
- The cGMPs and Process / Equipment / Facility Validations
- The 11 "must have" elements of software validation – 2 involve risk
- CAPA – a crucial series of risk-based lifecycle deliverables
- P&PC / HACCP – risk analysis is inherent
- Management Review – tying it all together; taking it to the next level
Who Will Benefit:
- Senior management, project leaders, internal / external consultants
- Regulatory affairs
- Quality systems personnel
- R&D and engineering staff
- All charged with new product development, regulatory submissions, initiating / overseeing company-wide quality management / planning, and desiring to utilize a risk-justified approach
- CAPA and P&PC personnel desiring to minimize post-production / life cycle, root cause investigation, and other costly problems
Instructor Profile
John E. Lincoln, consultant, has successfully designed and implemented complete 21 CFR 210, 211, 820 and ISO 13485 quality management systems, which have passed FDA audits, and described in peer-reviewed technical articles and workshops, world wide. John has also managed pilot production, regulatory affairs, product development / design control projects. He has over 25 years of experience, primarily with medical devices – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine, the Journal of cGMP Compliance, Intermountain Biomed- ical Association, and publishes a newsletter. He is a graduate of UCLA.
|
