Implementing a Robust Change Control Program – Key Elements for Process and Documentation Compliance

Teachers
Kelly Thomas
Category:
Manufacturing/ Med Device/ On Demand Courses/ Quality/ Regulatory & Compliance/ Research & Development/
Clear
Duration: 90-Minutes
On-Demand
Includes handouts!

Description

COURSE DESCRIPTION

OVERVIEW

Regulatory agencies require pharmaceutical and medical device companies to have a systematic approach to managing all changes made to their facilities, products, and/or quality systems.  Given the fact that changes are inevitable, it is essential that companies have a compliant and effective change control program to ensure that no unnecessary or cGMP-related changes occur.  Documentation of change control, including document authoring, updates, archiving, and related activities are not only a critical component of this exercises, but are also mandated by all global health authorities.

This course will discuss regulatory expectations from the FDA, EU and ICH perspective, review all the required components of a thorough change control program, and discuss the elements regarding successful management an effective change control system.

LEARNING OBJECTIVES

At the completion of this course, attendees will be able to:

  • Interpret the requirements of the FDA, EU and ICH guidelines regarding compliant Change control records.
  • Explain all the required components of a thorough Change control record
  • Recognize the critical aspects of documentation and document control
  • Apply all the elements of effective Change control management

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to anyone working in a manufacturing, facilities, or quality environment on global or domestic scale who are involved in change control or quality systems. This includes personnel in:

  • Production
  • IT
  • Facilities and Engineering
  • Validation
  • Quality Control
  • Quality Assurance
  • Regulatory Affairs

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 and use Option 3 (9am – 5pm EST, M-F) for assistance.

About Instructors

Kelly Thomas
Kelly Thomas | cGMP QA/QC Expert

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