Quality Oversight of Manufacturing Documentation

Description:

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:

• Systems, Personnel
• Buildings and Equipment
• Mandated Documentation and Records
• Materials Management
• Production and Laboratory
• Validation
• Material Rejections / Reuse
• Post-production Issues, Regulations and Auditing

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:

• The QMS, in accordance with ISO 9001, ISO 13485, and the key CGMPs
• A QMS overview
• Systems, Personnel, the Physical Plant
• If it isn't documented, it didn’t Happen - Documentation's Key Roles
• Control of material, product, manufacturing
• Laboratory Controls
• Validations
• Material / product rejection, release
• Complaint handling and other post-production issues
• A typical internal and/or regulatory audit of the QMS

Who Will Benefit:

• Senior management in business / industry
• QA / RA
• R&D
• Engineering
• Production
• Operations
• Marketing
• Consultants; others tasked with pharmaceutical development, manufacturing, logistics and V&V responsibilities

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 43 years experience in U.S. FDA-regulated industries, 29 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, worldwide. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product development / documentation, 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, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, chapters in books including 6 chapters in two RAPs textbooks on validation, conducted workshops and webinars worldwide. John is a graduate of UCLA.

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