3-Hour Virtual Seminar on Quality Management Bootcamp

Whar are the basics of a Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001.

ISO 9001 is an internatioinal standard for Quality Management Systems for all business or industrial systems, and is used as such by companies worldwide. It emphasizes the key principles that should be emphasized and those areas to be avoided, based on regulatory inspection / audit findings. It will discuss the key parts of ISO 9001, especially how it applies to manufacturing, but with application suitable for many different business activitie. ISO 9001's principles are incorporated in the US CGMPs (Good Manufacturing Practices) for pharma, 21 CFR 210 and -211 (actually the other way around), and in ICH Q7, GMPs for APIs (Active Pharmaceutical Ingredients). Further emphasis on QMS principles will be discussed by evaluating the conduct of a regulatory audit, and the major areas to address.

Why You Should Attend: "This seminar 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
• Documentation and Records
• Materials Management
• Production and Laboratory
• Validation
• Material Rejections / Reuse
• Post-production Issues and Auditing

• A QMS ovverview
• Systems, Personell, the Physical Plant
• If it isn't documented, it didn’t Happen
• Control of material, product, manufacturing
• Laboratory Controls
• Validations
• Material /product rejection, release
• Complaint handling and other post-production issues
• A typical regulatory Audit of the QMS

• Senior management in business / industry
• QA / RA
• R&D
• Engineering
• Production
• Operations
• Marketing