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.
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
One of the top 10 FDA 483 and Warning Letter citations is for inadequate change control. Change control receives detailed scrutiny during FDA inspections, and FDA reviews change control documentation to determine that changes do not adversely impact products, processes, equipment, facilities, etc. Any individually inadequate change may lead to significant negative events, including release of sub-standard product or product recall. A pattern of inadequate changes may require costly and time-consuming system remediation efforts.