Why Should You Attend:
Change Control is a critical element of the Quality Management System. Changes to processes, equipment, facilities, materials/components, suppliers, test methods, specifications, etc; must be properly managed to prevent unintended consequences, and to comply with regulatory requirements. Improper change control can result in significant compliance and product quality problems.
This webinar will help attendees understand the fundamental change control steps and skill sets. It will focus on change proposals, assessments, execution and final implementation. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed.
Areas Covered in the Webinar:
Who Will Benefit:
Andrew Campbell, has 25 years of pharmaceutical quality assurance and quality systems experience in both industry and consulting roles. Mr. Campbell has worked in clinical supply and commercial manufacturing environments, and has experience with integrated manufacturing and contract manufacturing business models. He has extensive expertise in the areas of Deviation-CAPA, Change Control, GMP Auditing, GMP Training, and Regulatory Inspection Preparation & Management.
Working with large and small companies, Mr. Campbell has successfully developed, remediated and implemented key Quality Systems. He is a skilled GMP Auditor, and has audited multiple API, Drug Product, Packaging, Testing and Distribution facilities. Mr. Campbell is an experienced GMP Trainer, and has developed customized and interactive training presentations for many companies. He has also provided FDA inspection support for several clients, including readiness training, on-site assistance during inspections, and authoring of written responses to inspectional observations.
Prior to becoming a consultant in 2007, Mr. Campbell worked for Ligand Pharmaceuticals as Director of Quality Systems.
FDA has issued a number of recent 483 citations and Warning Letters for inadequate change control. FDA expects proposed changes to be thoroughly reviewed by appropriate subject matter experts, in order to assure that the changes do not result in negative outcomes. Changes must also be properly justified, assessed for risk, implemented, and documented. Furthermore, certain major changes (e.g. manufacturing, specifications) may require regulatory filings and/or prior regulatory approval. Ultimately, improper change control can lead to negative 483 findings, Warning Letters, sub-standard product, or product recall.
An effective change control system relies upon the combination of sound procedures and personnel who understand how to properly describe, assess, and implement changes. Just completing a change control form is not enough. All involved personnel must have subject matter expertise, critical thinking skills, and the ability to clearly document their actions within the change control system, or related systems. At the end of the day, it should be clearly understood what changed, why the change was made, what risks were identified and/or mitigated, how the change was implemented, and whether the change was effective.
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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).
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