Change Control - Implementation and Management


Instructor: John E Lincoln
Product ID: 700160
Training Level: Intermediate to Advanced

  • Duration: 60 Min
This Change Control training will helps in change control implementation and management to ensure that documentation reviewed years later correctly reflects how product was designed, produced, tested, and released years earlier.
Last Recorded Date: Nov-2006


1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)



Customer Care

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Read Frequently Asked Questions

Starting with Design Control, and progressing into production, testing and release. Change control of each Device Master Record is mandatory to allow meaningful hazard analysis/risk management, product validations, CAPA/P&PC, product/system continuous improvement. It prevents waste of limited company resources (personnel, budget, time). Change control ensures that documentation reviewed years later correctly reflects how product was designed, produced, tested, and released years earlier. Essential to prove a company’s due diligence, and minimize liability. Without change control, there is no quality system!

Areas Covered in the seminar:

  • CGMP and ISO 13485 requirements
  • Involvement in many 483s
  • Change control and QSIT
  • Major industry problems with Change Control
  • SUPAC, Validation, and Technology Transfer Issues
  • Preventing negative changes
  • Maintain a ’state of control’; Management Review
  • Risk Management (per ISO 14971) and Change Control
  • When to report to agencies

Who Will Benefit:

  • Senior management, project leaders
  • Regulatory affairs
  • Quality systems personnel
  • R&D and engineering staff
  • All charged with new product development, regulatory submissions, initiating/overseeing company-wide training, production, validation, and statistical analysis
  • CAPA and P&PC personnel desiring to minimize post-production/life cycle and other costly problems.

Instructor Profile:

John E. Lincoln, consultant, has successfully designed, written and run all types of qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control projects; with over 24 years of experience, primarily in the medical device industry.

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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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