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

This webinar will explain FDA regulatory records requirements for medical devices and finished pharmaceuticals. It will cover statutory requirement, required content, format, purpose, retention, and structure for regulatory records for both medical devices and pharmaceuticals.

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

Pharmaceuticals

• 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.