Post Market Activities are a GMP regulatory requirement for the medical device industry in both the US and European Union. These activities provide a valuable system for obtaining data and continuous feedback about a medical device that is on the market. The objective of Post Market Activities is to utilize real-world data in order to maintain a high standard of product quality and ensure patient safety.
Recently, the European Union has revised the regulatory requirements governing medical devices; including the establishment of new expectations and approaches to post-market surveillance. Mandatory compliance to the new European Medical Device Regulation (MDR) is set for 26 May 2020. Due to the regulation changes, medical device manufactures are focused on implementing quality systems to maintain GMP compliance. In order to achieve that goal, it is essential that medical device manufacturers understand and correctly implement the requirements for post-market surveillance.
This course will review the new EU-MDR requirements governing Post Market Activities and discuss quality system approaches to ensuring compliance.
Why Should You Attend
At the completion of this course, attendees will be able to:
- What are the key elements of a PMS system?
- How should a PMS system function?
- What is the role of risk management in PMS?
- How do I implement data collection and review procedures
- How does a PMS system benefit my company?
Topic 1: Benefits of Post-Market Surveillance
Topic 2:Review the new EU-MDR 2017/745
- Key compliance dates
- Transition from Re-active to Pro-active
- Data Inputs and Collection Methods
Topic 3:Risk Management
- Benefit – Risk Determination
- Post-Market Clinical Follow-up (PMCF)
Who will Benefit
Employees who are required to submit regulatory information to the EU Regulatory authorities as part of their job function – includes some or all of the employees in the following departments:
- Quality Assurance
- Regulatory Affairs
Industries who can attend
This 180-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel
Faculty Kelly Thomas
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.