Compliance Key INC - Medical Device training
Charles H. Paul is Keynote Speaker at Compliance key Inc. He is President of C. H. Paul Consulting, Inc. - a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc.
Overview
Design Controls are the processes used to design, develop, and manage medical devices that you manufacture. They are mandated by federal regulation however the regulations concerning design controls are vague in terms of the specific process steps required and the approaches that should be taken to achieve compliance should be developed.
Knowing how the FDA both views and examines design controls is crucial to achieving compliance throughout the life of the medical devices you manufacture and is one of the most valuable compliance subject areas to explore. Noncompliance in design controls, which are consistently uncovered by the FDA during inspections and examinations, are concerned with the design control process that has been designed and applied and the documentation required to support each design control step. The specific sections of the regulations that apply to design controls include CFR 21 Part 820 Quality System regulation found in Sec. 820.30 and Sec. 820.40. These sections of the regulation are extremely complex and difficult to apply particularly for companies that are new to the medical device field. This webinar will explore how design controls should be designed to meet both the spirit and intent of the regulation and the needs of both the medical device itself and the organization.
Knowing how the FDA both views and examines design controls is crucial to achieving compliance throughout the life of the medical devices you manufacture and is one of the most valuable compliance subject areas to explore. Noncompliance in design controls, which are consistently uncovered by the FDA during inspections and examinations, are concerned with the design control process that has been designed and applied and the documentation required to support each design control step. The specific sections of the regulations that apply to design controls include CFR 21 Part 820 Quality System regulation found in Sec. 820.30 and Sec. 820.40. These sections of the regulation are extremely complex and difficult to apply particularly for companies that are new to the medical device field. This webinar will explore how design controls should be designed to meet both the spirit and intent of the regulation and the needs of both the medical device itself and the organization.
Why should you attend this webinar?
The number of medical device recalls over the past several years has almost doubled each year indicating that the FDA is increasingly looking at the medical device industry in general and how products are designed and managed in particular. Manufacturers are at significant compliance risk when their design control processes are flawed and are not carefully designed. Compliance risk has significant health and safety implications that medical device companies today can simply not ignore.
Areas Covered in the Session:
- CFR 21 Part 820 Quality System regulation found in Sec. 820.30 and Sec. 820.40
- Design control process steps
- Designing your design control process - the design control planning process
- Mapping your design control process to the FDA's interpretation of design controls
- Design inputs and outputs
- Verification process
- Validation process
- Importance of process step documentation
- Review processes
- Life cycle management
- Compound products
- Medical device applications
Who can Benefit:
Anyone involved in the design, development, and manufacturer of medical devices that has had some exposure to the subject area and regulated environments.
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