One of the 4 major areas for FDA-regulated companies’ product compliance is CAPA (Corrective and Preventive Action).
Both CAPA, all associated complaint handling and adverse events / MDR reporting systems require the ability to dissect a problem and get down to the root cause, in order to handle product correction, impact analysis, corrective action, and preventive action. Root cause analysis is therefore fundamental to addressing and solving problems, as well as developing methods to prevent their (and other related problems) recurrence. Root cause analysis is inherent in Hazard Analysis / Product Risk Management under ISO 14971, a component of any viable lean 6-sigma program, and makes for good business.
Areas Covered in the seminar:
- Developing and using the Investigation Template.
- 4 basic steps to problem solving.
- 7 basic and simple tools - powerful tools.
- Tools for investigation.
- Tools for problem solving.
- Validate.
- Monitor.
- After the "real" root cause(s) is identified - Now what?
- When to "jump out of the process"?
Who will benefit:
- Management at all levels.
- Project Leaders.
- Regulatory Affairs.
- Quality Systems Personnel.
- R&D and Engineering Staff.
- All charged with new product development, risk analysis / management, regulatory submissions, initiating / overseeing company-wide training, production, validation, and complaint handling.
- Identified staff, operations and line personnel who desire to assume "train-the-trainer" roles to train teams in problem / OOS reduction.
Instructor Profile:
John E. Lincoln, Consultant, has successfully developed and implemented and trained to device, pharma, medical gases, and dietary supplements CGMP-compliant systems. He has conducted compliance audits in all these areas. His systems have passed FDA audit or submission scrutiny, and have been described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development projects; with over 25 years of experience, in FDA-regulated industry - 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 and the Journal of cGMP Compliance, and Intermountain Biomedical Association); he publishes a newsletter. He is a graduate of UCLA.
