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

Join us for a webinar on October 26 for a discussion of the webinar .

Medical device regulations in the EU are changing and changing fast. If your business is global, you can’t avoid these crucial adjustments.

With one extension already granted, any organization selling devices in the region now need to be ready for the shift by May 2021. There’s little time to spare to get your processes up to par — but WCS can help get you there.

Who Will Benefit

 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:

  • Regulatory compliance personnel
  • Quality managers and directors
  • Quality engineers
  • Risk management specialists
  • Regulatory managers
  • Design engineering managers
  • Supply chain managers focused on procurement and distribution
  • Production managers and engineers
  • Document control specialists
  • Marketing managers
  • Clinical managers
  • Clinical evaluation specialists
  • Export compliance managers

Agenda

Module 1 

Benefits of Post-Market Surveillance

Module 2 

Review the new EU-MDR 2017/745

  • Key compliance dates
  • Transition from Re-active to Pro-active
  • Data Inputs and Collection Methods
  • Trending

Module 3

  • Risk Management
  • Benefit – Risk Determination
  • Post-Market Clinical Follow-up (PMCF)

Overview

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?


Kelly Thomas

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.  

Choose a Purchase Options



$399

Live Webinar - Single Partcipant

You get one log-in for the live 180-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email

$499

Live Corporate Group Up to 5 Participants ( Recorded Access Included )

Virtual Seminar Up to 5 Participants

Up to 5 Dial In is allowed from home or office .

$399

On Demand Access 6 month

You'll have access to one log-in for an archived recording of the entire 180-minute webinar, including the Q&A period for a group. 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

$499

Training DVD

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.