The Center for Professional Innovation & Education, Costa Mesa, CA
Who Should Attend
Because of its comprehensive overview, this two-day course will be valuable to both Medical Device and Pharmaceutical regulatory affairs professionals, quality assurance managers, quality control managers, engineers, engineering managers, and quality engineers, product developers, manufacturing managers, compliance officers, 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.
Upon completion of this course, you will have gained an understanding of how to effectively meet the requirements of Post Market surveillance and Vigilance for Medical Devices and Pharmaceutical products. An emphasis will be placed on effective Complaint Handling, Post Market surveillance and Vigilance processes.
The first day will cover the general requirements from FDA's, CE Marking, Directives 90/385/EEC, 93/42/EEC, 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.
Product recalls and market withdrawals on the increase and 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 drugs failure are minimized.
This course will provide a thorough understanding of the regulatory expectations for Post Market surveillance requirements for Drugs and Devices; this comprehensive training course outlines how to apply the appropriate guidances and requirements to your products.
Comprehensive review of expectations regarding Post Market surveillance documentation and the FDA's, CE Marking requirements under the Directives 90/385/EEC, 93/42/EEC, as well as Health Canada's requirements will be discussed. 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 Complaint Handling, Post Market surveillance and Vigilance for Medical Devices and Pharmaceutical products. Additionally, the course will detail the type of data required, as well as, how to analyze data 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.