San Francisco, California
London, United Kingdom
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
Note: Use coupon code NB5SQH8N and get 10% off on registration.
When & Where
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.