This webinar will examine the key elements of ISO 9001, for basic QMS elements. Followed by a dettiled analysis of ICH Q7, the API CGMP requirements, among the most complete and stringent.. Product development and manufacturing ("realization") and its compliance and documentation.Design Control, the Device History File, the Device Master Record and the Device History Record are defined. Corrective and Preventive Action (CAPA) requirements and key components. Production and Process Control (P&PC) expectations. Verification and Validation, including software - Why and How? Risk management, a major component of the ne US FDA device QMSR, will also be considered. Differing approaches to compiance inspections / audits internally by the company and externally by the FDA. A discussion of FDA's new revised 820 incorporating ISO 13485, into the new QMSR, will also be included.

Areas Covered in the Session:-

The U.S. FDA's CGMPs - Device and Pharma
The Documentation Requirements

Learning Objectives:-

Design Contol; Risk Management, and Human Factors / Use Engineering
Management Responsibility
Production and Process Controls
CAPA
DHF Required Contents
The Risk Management File (ISO 14971) and its role
The Use Engineering File (IEC 62366-1) and its role
Expected QMS Records
The DMR and DHR
FDA Inspection / Audit Focus.

Background:-

What are basic requirements of international (and US) Quality Management Systems? ISO 9001, ICH Q7 for APIs, and basie CGMP requirements will be discussed, and are applicable for Medical Devices, Pharmaceuticals, and other Regulated (and other) products world wide.

Why Should You Attend?

Global companies must meet basic QMS requirements no matter what country they sell into. They must meet US FDA 21 CFR 820 (The QMSR) requirements in order to sell such devices in the US, and 21 CFR 211 requirement for drugs, no matter where they are manufactured. Similiar requirements are true in Europe and Asia - basically worldd wide. What are the key requirements of a compliiant QMS? Least stringent to most complex? In this webinar, will be done by an examination of ISO 9001 requirements (the basic QMS requirements), and also the more stringent ICH Q7 requirements, for APIs (Active Pharma Ingredients). Most companiers in nation and/or global marketplacse are familiar with ISO 9001 and its derivitives.

Who will Benefit:-

Senior management
Regulatory Affairs
Quality Assurance
Production
R&D and Engineering

All personnel involved in the U.S. FDA-regulated medical products quality, and manufacturing environments. Especially those involved in new medical device / combination product development, line extensions, and incremental product improvements; having to evaluate those changes in light of the DHF / CGMPs, and then document these actions in harmony with the regulations.

John E. Lincoln

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).