Implementing a Robust and Compliant Change Control Program
Instructor:
Kelly Thomas
Product ID: 705909
Training Level: Intermediate to Advanced
- Duration: 90 Min
Why Should You Attend:
Regulatory agencies require pharmaceutical and medical device companies to have a systematic approach to managing all changes made to a facility, their product or a quality system. 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 non-compliant changes occur.
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.
- Understand all the required components of a thorough Change Control record.
- Understand all the elements of effective Change Control management:
- How to develop a cross-functional team to ensure proper evaluation, approval and implementation of proposed changes.
- Ensure changes do not negatively impact the business or established marketing authorization.
- How to incorporate a Quality risk based approach to evaluating proposed changes
- Ensure changes are implemented in a timely manner by effective use of the Change Control Review Board (CCRB) and Quality Metrics
Areas Covered in the Webinar:
Topic 1: Regulatory Guidance Review
- FDA (CFR)
- EU (EurdraLex)
- ICH Q10
Topic 2: Review all Elements of a Change Control Record
- Discuss the importance of utilizing Subject Matter Experts from multiple functional areas to ensure proper evaluation, approval and implementation of proposed changes.
- Ensure changes do not negatively impact the business or established marketing authorization.
- How to incorporate a Quality risk-based approach to evaluating proposed changes
- Ensure changes are implemented in a timely manner by effective use of the Change Control Review Board (CCRB) and Quality Metrics
- Understand what steps should be taken post implementation to confirm the objectives were achieved
Who Will Benefit:
- Operations
- Quality Assurance
- Regulatory Affairs
- Validation
Kelly Thomas
Vice President, Americas Quality Operations
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
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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).
