Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Join us for a webinar on July 08  for a discussion of the webinar

If you’re involved in any aspect of quality management systems (QMS) for your medical device, outsource parts of your supply chain, and/or rely on the cloud for some of your CGMP compliance, you need a strong change management process in place to avoid change interaction, where one change type triggers another change type.

Being familiar with common methods for specific change types that affect everything from post-market design to corrective and preventive action is also key for a smooth medical device production process.

Join WCS and John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC for a comprehensive overview on July 8th. Mr. Lincoln will review best practices, processes and methods to support medical device change management. The presentation will cover change activities in FDA QSR, ISO 13485:2016, EU-MDR Article 10, and EU-IVDR Article 10

Webinar Takeaways

  • Familiarize yourself with the overarching change management process and methods
  • Assess how to apply the process to specific change types
  • Determine the change interactions in the change types
  • Master how to apply the process to specific QMS requirements
  • Identify the similarities and differences across QMS requirements
  • Identify the similarities and differences across QMS requirements
  • Key elements of the change management process and its applications.

Ensure a consistent approach to your change management process and avoid problems associated with ad hoc methods. Join us by registering today

Can't Make this LIVE Webinar?

Simply select the On Demand option when registering and we will send you the link to view the recorded version.

Who will Benefit

  • Medical device manufacturers
  • Design engineering managers and supervisors
  • Regulatory affairs managers and supervisors
  • Quality management managers and supervisors
  • Risk management managers and supervisors
  • Production managers and supervisors
  • Quality managers

Industries who can attend

This 60-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 John E Lincoln

John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS / CGMP audits and problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).

Faculty John E Lincoln

Choose a Purchase Options

$229

Live Webinar - Single Participant 60-mins

You get one log-in for the live 60-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email

$287

Recorded Access Single - 6 month Access

You'll have access to one log-in for an archived recording of the entire 60-minute webinar, including the Q&A period, for 1 participant. 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

$349

MP3 Download (DVD)

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

$349

Live Webinar + Recording

You get one log-in for the live 60-minute webinar for one participant and Access to archived recording of the entire 60-minute webinar, including the Q&A period, for 1 participant. You can log in any time of day or night.