The Center for Professional Innovation & Education, Malvern, PA
March 5 & 6, 2009
Who Should Attend This two-day course will be valuable for: - Regulatory Affairs professionals
- Quality Assurance managers
- Quality Control managers
- Engineers and Engineering managers
- Quality Engineers
- Product Developers
- Manufacturing managers
- Compliance officers
Those who are new to the industry or to their current position and do not have an in-depth knowledge of complaint handling, post market surveillance, and vigilance requirements will also benefit from this course.
Learning Objectives Upon completion of this course, attendees will have gained an understanding of how to effectively meet the requirements of post market surveillance and vigilance for medical devices and pharmaceutical products. The first day will cover the general mandates from the FDA, as well as, CE Marking, Directives 90/385/EEC and 93/42/EEC, plus Health Canada and Japan’s requirements. The second day will discuss additional regulatory topics and will review procedures to develop an effective program. General quality system topics will be covered as they relate to the post market surveillance and vigilance processes.
Course Description
With product recalls and market withdrawals on the increase, regulatory agencies are placing greater emphasis on post market surveillance as a way to improve risk management. A successful post market surveillance strategy will ensure that the risk to patients and the number of unforeseen adverse events from device and drug failure is minimized. This course will provide a thorough understanding of the regulatory expectations for post market surveillance mandates for Drugs and Devices and outline how to apply the appropriate guidances and requirements to your products. Additionally, this course covers complaint handling and post market surveillance implementation problems, requirements and future applications. The attendee will learn how to apply these requirements to effectively develop processes for compliance. The course will also detail the type of data required, as well as, how to analyze results to determine if product changes may be needed. By the end of this course, participants will have the skills and knowledge necessary ensure compliance in an efficient, cost-effective manner.
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