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Introduction To Medical Device Regulation
Overview
Introduction to Medical Device GMPs focuses the participant on understanding the key components of 21 CFR 820. This introductory course provides baseline knowledge of these regulations through engaging interactions and exercises.
Course Outline
- What are the Medical Device cGMPs?
- What is the Quality System Regulation?
- Introduction to General Provisions (Subpart A) of 21 CFR 820
- Subparts B,C, D and its application at your organization
- Subparts E,F and its application at your organization
- Subparts G, H, I, J and K as it relates to the quality system and application at your organization
- Subpart L and its importance in outsourcing application at your organization
- Subpart M and how it relates to the quality system
- Subpart N and O review and application at your organization
- How GMPs are enforced and FDA Regulatory Action
**Class Length 4 - 6 Hours depending on customization
The Problem
- Are you a Medical Device facility that needs interactive and fun GMP training?
- Do you need a fresh and energetic way to train new and current employees on medical device GMPs?
- Do you need a GMP program that really teaches your employees the fundamentals of this important regulation?
- When asked what GMP or QSR is, do your employees say, “huh?”
Our Solution
To Learn...
- The basic components of medical device GMPs/QSR and how the regulation is organized and documented
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