| Available : All Days | Presented By : John E. Lincoln |
| Category : Pharmaceutical | Event Type : Recorded Webinar |
For group or any booking support, contact: cs@conferenceschedulers.com +1 (844) 449-0244 (US Toll Free)
This webinar will evaluate the requirements for the foundational / basic Quality Management System (QMS), ISO 9001m and how most QMS' requirements build upon that foundation. Then it will go into a detailed analysis of the basic requirements of ISO 9001 and what that means for the typical manufacturing company (and others). Subject areas considered are:
Why Should You Attend:
What are the basics of a Quality Management System and the documentation that supports and validates it? This webinar will examine these questions by means of several international standards, ISO 9001. ISO 9001 is an international standard for Quality Management Systems for all business or industrial systems, as well as the more specialized one for medical devices, ISO 13485. Standards that are used as such by companies worldwide. It examines the role the QMS plays in proving completion of defined activities by proper documentation. It also focuses on the key principles that should be emphasized and those areas that are to be avoided, based on regulatory inspection / audit findings. It will discuss the key parts of the standards and related CGMPs, such as 21 CFR 210 and 211 for pharma, and 21 CFR 820 for devices. The relationship between ISO 9001 and the US CGMPs (Good Manufacturing Practices) for pharma, 21 CFR 210 and -211, ICH Q7, GMPs for APIs (Active Pharmaceutical Ingredients), and devices 21 CFR 820.. The conduct of an external regulatory audit, the required annual internal audit, and the major areas to address will be discussed ..
Areas Covered in the Webinar:
Who Will Benefit:
John E. Lincoln is the Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years of experience in U.S. FDA-regulated industries, 18 of which as a full-time independent FDA-regulated industry consultant. Mr. Lincoln has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China, and Taiwan. He specializes in quality assurance, regulatory affairs, QMS / CGMP audits, problem remediation and FDA responses, new/changed product 510(k)s, process/product/equipment including QMS and software validations, ISO 14971 product risk management files/reports, Design Control / Design History Files, Technical Files. He’s held positions in Manufacturing Engineering, QA, QAE, and Regulatory Affairs, to the level of Director and VP (R&D).
| Title | Category | Type |
|---|---|---|
| Validation Master Plan - The Unwritten Requirements | Pharmaceutical | Recorded Webinar |