Change Control: How to Manage Changes within a GMP Environment
Expired

  • June 27, 2017
    9:00 am - 4:30 pm

Location

6257 Airport Rd, Mississauga, Ontario, Canada, L4V 1E4
QA

Certification Areas

Event Objective

This course will provide guidance on the handling of changes that can occur in the pharmaceutical industry. It will help the attendee to navigate through the changes from inception to completion while maintaining compliance with the Good Manufacturing Practices.

Event Description

The course will cover the steps of a Change Control and how to determine the needed actions. Topics will include:

 

  • Identification of a change.
  • Writing and implementation of a Change Control Standard Operating Procedure.
  • Starting the change process.
  • Proper GMP documentation.
  • Identifying implementation tasks.
  • Assigning time lines.
  • What to do to make the change happen.
  • Evaluation of the effects of the change.
  • Finalizing the change.

Who Should Attend

All staff who are involved in the Drug, Medical Device  or Natural Health Products  industry including fabricators, packagers, labelers, wholesalers, distributors and testers should attend this course. Quality Assurance and Quality Control and Regulatory personnel along with any of the staff members having job functions that involve any of these products would also benefit from this course.

Speaker



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