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.
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.
Terry Pilkey has been in the Pharmaceutical and Medical Device industry for 37 years.
She was employed by Health Canada as a Drug Analyst, Medical Device Inspector and Drug Inspector for 15 years before moving to the private industry.
Terry started the Regulatory and Quality Consulting Division at Eurofins Experchem Laboratories Inc. in 1994.
She is currently the Director of Regulatory Affairs and as such provides regulatory and quality guidance and Quality Control support to firms on Good Manufacturing Practices compliance and maintenance of Drug Establishment Licenses, Site Licenses and Medical Device Establishment Licenses.
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