Overview
Whar are the basics of an enterprise maintenance-focused Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001, the internatioinal standard for Quality Management Systems for all business or industrial systems worldwide.
This webinar will discuss basic requirements of a QMS. It will then develope those areas of QM that specifically guide CAPA (Corrective and Preventative Action), preventive / predictive (proactive rather than reactive) maintenance, routine and urngent maintenance / repairs, inspections, and continuous improvemnt, and some of the basic tools under SPC and 6 SIgma to achieve those goals. The emphasis of this webinar will be maintenance activities that work under the QMS "umbrella".
Why should you Attend
"This webinar will evaluate the requirements for the foundational / basic Quality Management System (QMS), ISO 9001m and how a company's preventative and predictive maintenance programs can be enhances by the QMA requirements, as outlined in ISO 9001. Subject areas considered are:
- Systems, Personnel
- Buildings and Equipment, Preventive and Predictive Maintenance
- Documentation and Records
- Materials Management
- Production and Laboratory
- Validation
- Material Rejections / Reuse
- Post-production Issues; Analytics (descriptive, diagnostic, predictive, prescriptive)"
Areas Covered in the Session
- A QMS ovverview
- Systems, Personel, the Physical Plant
- If it isn't documented, it didn’t Happen
- Control of material, product, manufacturing
- Preventive and Predictive Maintenance
- Validations
- Material /product rejection, fall-off, scrap issues
- Complaint handling and other post-production issues
Who Will Benefit
- Senior management in business / industry
- QA / RA
- R&D
- Engineering
- Facilities and Maintenance
- Production
- Operations
- Marketing
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.
John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
Instructor
John E Lincoln
