Regulatory Records Primer: Decoding the Requirements for Medical Device and Pharmaceutical Manufacturers

Why Should You Attend:

In the eyes of the FDA, manufacturing safe and effective products is not an option, nor are the records required to document those activities. Aside from the need to satisfy those regulatory requirements, having useful, clear, and complete chronicles of the processes followed could be of significant benefit to the organization in the event of a product liability action against it. Those records, if properly constructed, completed, maintained, and filed could eliminate additional regulatory actions, adverse publicity, and actual and punitive damages.

This webinar will provide attendees with detailed information on the required regulatory records for their industry and provide examples of both proven record design and best practices that will satisfy the FDA’s requirements for regulatory records. Dos and don’ts with respect to records will also be discussed during the session.

Learning Objectives:

• Understand the FDA’s regulatory records requirements for medical devices and finished pharmaceuticals.
• What are the format requirements for regulatory records?
• What are the potential penalties for not maintaining regulatory records?

Areas Covered in the Webinar:

For each of the required regulatory records identified below, the session will address the statutory requirement, required content, format, purpose, retention, and structure. Examples will be provided that can be tailored for individual company use. Misnomers will be clarified and Good Documentation Practices will be explained.

Medical Devices

• Design History File
• Device Master Record
• Device History Record
• Complaint Files
• Quality System Record

• Master Production and Control Record
• Batch Record
• Equipment Cleaning and Use Log
• Component, Drug Product Container, Closure, and Labeling Records
• Distribution Records
• Laboratory Records
• Complaint Files
• Production Record Review

Who Will Benefit:

This webinar will provide valuable assistance to the following departments of medical device and pharmaceutical manufacturers:

• Quality Assurance/Quality Control Directors, Managers, and Specialists
• Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists
• Document Control Managers and Coordinators
• Information Technology/Information Systems Directors and Managers

Instructor Profile:

Les Schnoll, has extensive experience in quality assurance, quality control, auditing, regulatory compliance, management, and microbiology in the medical device, pharmaceutical, and clinical/pre-clinical industries. Schnoll is recognized for achievements in developing value-added quality management and regulatory compliance systems. He is recognized by the Medicines and Healthcare Products Regulatory Agency (MHRA) (formerly the Medical Devices Authority) in the United Kingdom to perform assessments to the European Union Medical Device Directive and the European sterilization standards.

Mr. Schnoll is the Principal of Quality Docs, LLC, providing quality and regulatory services to the FDA-regulated and Arizona Department of Health-regulated industries. He is also currently an Instructor in the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Device program in the College of Professional Studies at Northeastern University and a Faculty Associate at Arizona State University, College of Nursing and Health Innovation, in the MS Regulatory Science and Health Safety Program. He was most recently the Vice President, Quality Assurance and Regulatory Affairs with the J.T. Posey Company and has held executive positions at ThermoGenesis, Theravance, Solectron, Hill-Rom, Gliatech, Cyberonics, Southern Research Institute, KPMG Quality Registrar, and Dow Corning Corporation. Les has conducted various training programs, audits, and systems development in the United States, Canada, Europe, South America, Russia, Australia, and the Pacific Rim.

Schnoll has written articles for such publications as Medical Design and Material, ISO 9000 Handbook of Quality Standards and Compliance, Pharmaceutical and Medical Packaging News, Food Quality, and Quality Progress. He is also the author of The CE Mark: Understanding the Medical Device Directives and The Regulatory Compliance Almanac, published by Paton Press.

Schnoll’s professional affiliations include the American Society for Quality as a Certified Quality Engineer, Certified Quality Auditor, and Certified Quality Manager; the Regulatory Affairs Professionals Society as Regulatory Affairs Certified; the Institute of Certified Quality Consultants as a Certified Quality Consultant; the American Society for Microbiology as a Registered Microbiologist (clinical microbiology) and Specialist Microbiologist (consumer and industrial microbiology); and the International Register of Certified Auditors as a certified lead assessor. He is a Fellow of the Chartered Quality Institute (formerly the Institute of Quality Assurance) and is accredited as a Chartered Quality Professional. Schnoll is also a former member of the United States Technical Advisory Group to Technical Committee 176, International Organization for Standardization and the United States Technical Advisory Group to Technical Committee 210, International Organization for Standardization.

Schnoll has a Bachelor of Science degree in biology from Ursinus College, a Master of Science degree in microbiology from Villanova University, a Master of Business Administration in human resources from Central Michigan University, and a Juris Doctor in health law from Concord University School of Law.

Topic Background:

Manufacturers of both medical devices and finished pharmaceuticals are required to document their activities, including those of manufacturing and distribution. Those records enable the company to provide objective evidence of their adherence to their own policies and procedures, as well as to a myriad of regulatory requirements. In the United States, the FDA is not acquiescent on the types of records required, but they are flexible in how those records are structured and maintained. Knowing and understanding the various regulatory records, and constructing them in a value-added manner, will enable the organization to meet its obligations for documenting their activities.

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