Change Control Best Practices: Avoiding Unintended Consequences of Changes

Instructor: Andrew Campbell
Product ID: 703540
  • Duration: 90 Min

recorded version

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Read Frequently Asked Questions

This webinar will provide an overview of regulatory requirements for change control. It will focus on changes to equipment, facilities, materials/components, test methods, suppliers, specifications, etc.

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:

  • Overview of Change Control Regulatory Requirements
  • What is Change Control?/Why Change Control?
  • Types of Changes Subject to Change Control
  • Change Proposal
  • Change Assessment (Risk, Impact)
  • Approval to Execute Change
  • Executing the Change
  • Final Implementation of Change
  • Change Control Documentation

Who Will Benefit:

  • Regulatory Affairs
  • Qc/QA Personnel
  • R&D and Engineering Staff
  • Change Control Reviewers/Approvers (e.g. Validation, Regulatory Affairs, Quality Assurance)
  • Quality Assurance Management responsible for Change Control Systems
  • Supply Chain Managers

Instructor Profile:

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.

Topic Background:

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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