Change Control Best Practices - Avoiding Unintended Consequences of Changes, Boston, Thursday, 11. April 2019

Course Description:
With FDA citing inadequate change control constantly in its 483s and Warning Letters, the prerequisite to ensure that changes are accurately described, justified, assessed for risk, implemented, and documented has come to the fore. Changes must also be prospectively reviewed by appropriate subject matter experts. Furthermore, certain major changes (e.g. manufacturing, specifications) may require regulatory filings and/or prior regulatory approval.
This seminar will guide all personnel involved in proposing, assessing, and implementing changes to understand and successfully apply the fundamental change control steps and best practices. The key focus will remain on:

Change proposals
Justification / risk assessment
Change execution / implementation

The seminar will focus on changes to equipment, facilities, materials/components, test methods, suppliers, specifications, etc. Document change control will be discussed as a supporting element. Additionally, this practical, how-to course will illustrate and impart:

The importance of subject matter expertise, proper planning, critical thinking skills, and co-ordination of all change activities.
Skills needed for applying change controls within an organization.
Group exercises to allow participants to practice skill sets with feedback from the instructor.
Practical training by having participant teams complete a full write-up for a mock change control.

Learning Objectives:
On completing this course on FDA compliance, participants will be able to:

Understand regulatory requirements and FDA expectations for change control
Understand the purpose of change control
Identify what types of changes are /are not subject to change control
Properly describe a change
Properly justify a change
Develop a comprehensive change execution plan
Conduct a proper change risk assessment
Accurately execute a change
Accurately implement a change
Develop a full change control package
Utilize critical thinking skills throughout the change control process
Avoid pitfalls during the change control process

Who Will Benefit:
This course is designed from a pharmaceutical manufacturing perspective; however, since the main focus is on techniques and practices, the course material may be equally applied to biologics and medical device environments. It will benefit:

Change proposal authors
Reviewers / approvers of change controls
Change control system owners
Production staff / management
Engineering staff / management
Validation staff /management
QA and QC staff / management
Regulatory affairs staff / management


Andrew CampbellPharmaceutical Consultant - Quality & Compliance

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 and 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. He 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 written responses to inspectional observations. Prior to becoming a consultant in 2007, Mr. Campbell worked for Ligand Pharmaceuticals as director of quality systems.

For Registration - 
Note: Use coupon code  REFERRAL10  and get 10% off on registration.

Change Control Best Practices - Avoiding Unintended Consequences of Changes

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