Webinar Includes : All the training handouts , certificate ,Q/A and 180 mins Live Webinar

Training Overview

Post- Market Activites course will provide an overview of 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?

Webinar Takeaway

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
  • Trending

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


Faculty Kelly Thomas

Kelly Thomas

Vice President, Americas Quality Operations at Stallergenes Greer

Charlotte, North Carolina Area

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.  

Choose a Purchase Options

$389

Recorded Access Corporate Group

You'll have Group access to one log-in for an archived recording of the entire 180-minute webinar, including the Q&A period, for 1 location. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$899

Purchase Using Webinar All-Access Pass

(One user get unlimited access to all upcoming and recorded webinars (350+) for one year)


Our Participants Testimonial


The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals

About World Compliance Seminars (WCS)

World Compliance Seminars (WCS) is one stop solution for all your pharmaceuticalbiotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIHEMA, as well as numerous European based national regulatory bodies.

These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical ComplianceProcess Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.

The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.

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