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).
