Complying with Quality System (QS) Regulation Requirements and Exceeding Expectations: One-Day Primer for Medical Device Manufactures

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Course Description

The process of assuring FDA compliance to quality system requirements is different for every company, depending on company size, operations, and priorities. Current good manufacturing practice (cGMP) requirements are set forth in FDA’s Quality System (QS) regulation. The requirements in the QS regulation and in 21 CFR 820 govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements are intended to ensure that finished medical devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act. The QS regulation establishes basic requirements applicable to manufacturers of finished medical devices.

In the QS regulation, FDA has identified the essential elements that a quality system shall embody, without prescribing specific ways to establish these elements. Because the QS regulation covers a broad spectrum of devices and production processes, it allows some leeway in the details of quality system elements. It is left to manufacturers to determine the necessity for, or extent of, some quality elements, and to develop and implement specific procedures tailored to their particular processes and devices.

This interactive course will provide guidance and direction that will allow you to develop strategies, add business value, and minimize delays by providing strategic/tactical solutions that facilitate the achievement of regulatory and quality milestones.

Learning Objectives

  • Describe the importance of written, executable, and enforceable policies and procedures
  • Determine and relate to the benefits of compliance vs. risk of noncompliance
  • Implement FDA’s Quality System Inspection Technique (QSIT) and strategy for inspecting device manufacturers and latest trends
  • Describe the importance of good housekeeping for both the facility and documentation management system
  • Describe the importance of change control
  • Implement strategies for proper auditing and other surveillance tools and techniques
  • Establish and maintain a quality system that is appropriate for your device
  • Review recent and various enforcement actions taken 
Who Should Attend

  • This course is both a primer for personnel new to the FDA regulated industry or an excellent refresher course for those who need to revisit the basics and fundamentals for a defendable, justifiable, and sustainable compliance program. Those who will benefit include professionals in R&D, development, QA/QC, production, operations, engineering, compliance, regulatory affairs, and all levels of management, including technical and laboratory personnel.

The course will be led by one of the following instructors:

David R. Dills 

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Course Outline

Day 1: 8:30 a.m. – 5:00 p.m.

  • I. Regulatory Background and Snapshot: History, Definitions and terminology
    Guidelines and other informational sources, 21 CFR 820 (Quality System Regulation)
  • II. Critical and Key Sections: Quality System Requirements
    Management, design, production, process, and document controls, Validation, maintenance, and calibration; Corrective and Preventive Action (CAPA)
    Acceptance activities; Purchasing and supplier management and controls;
    Product identification and traceability;
    Purpose and role of written procedures/SOPs and other quality procedures;
    Handling deviations and nonconforming product; Handling, storage, distribution, and installation of your devices; Complaints and failure investigations;  Records: device master records, DHR, and other quality records; Servicing and statistical techniques; Training and surveillance
    Change control and Good Documentation Practices (GDP)
  • III. Execution: Who is involved and what “pay now or pay later” implies with FDA Inspections; FDA trigger points and red-flags; The cost of non-compliance and how much is enough in terms of risk mitigation; Techniques and strategies on how to survive the inspection – do’s and don’ts; Recent enforcement actions taken against device firms and common issues; Why QSIT (Quality System Inspection Technique) is a critical inspectional strategy, but preparation is the key to success; RBPs (Recommended Best Practices)
  • IV. Interactive Q&A, Wrap-Up and Adjourn: Q&A with all participants and attendees, including their real-world challenges.

Interactive Activities

Group discussion regarding the regulatory framework that all manufacturers must follow. Emphasis will be on attendees using good judgment when developing their quality system, and applying those sections of the QS regulation that are applicable to their specific products and operations. Recap, including updates, of CFRs, ICH, GCP and relevant guidance documents.

Registration Fees

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

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Special rates are available for multiple attendees from the same organization.  Contact Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.

Accreditation Information

ACPE LogoBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 7 hours (0.7 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE# 0778-0000-11-006-L01-P. Released: 3/11.

Hold this course at your company!

For more information, contact Naila Ganatra at (215) 413-2471.