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 did not adversely impact products, processes, equipment, facilities, etc. A single 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.
It is therefore critically important to assure that changes are properly described, justified, assessed for risk, implemented, and documented. 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 help all personnel involved in proposing, assessing, and implementing changes to understand and successfully apply Change Control best practices. Key focus will be placed on change proposals, justification / risk assessment and change execution / implementation. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed. Techniques for assuring robust Change Control programs in light of COVID-19 restrictions will also be discussed.
This is a practical how-to course, designed to provide participants with skills they can immediately apply to change controls within their own organizations. Case studies will allow participants to practice skill sets in cooperation with the instructor.
Learning Objectives:
Upon completing this course, participants should be able to:
- Understand the purpose of change control
- Understand regulatory requirements and FDA expectations for change control
- Identify what types of changes are /are not subject to change control
- Properly describe changes
- Properly justify changes
- Develop a comprehensive Change Execution Plan
- Conduct a proper change Risk Assessment
- Ensure proper execution of changes
- Ensure proper implementation of changes
- Develop a complete Change Control documentation package
- Utilize critical thinking skills throughout the change control process
- Avoid pitfalls during the change control process
Who will Benefit:
This course is designed for people tasked with:
- Authoring change proposals
- Assessing / approving change proposals
- Executing / implementing changes
The following personnel will benefit from the course:
- Change proposal authors
- Reviewers / approvers of change controls
- Change control system owners
- Production staff / management
- Engineering staff / management
- Validation staff /management
- QC staff / management
- Regulatory Affairs staff / management
- QA staff / management
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. Please note that this seminar focuses on changes to equipment, facilities, materials/components, test methods, suppliers, specifications, etc. Document Change Control is discussed as a supporting element; however, it is not the main focus.
- Regulatory Requirements
- FDA Change Control Expectations / Warning Letter Examples
- Purpose of Change Controls
- What is Change Control?
- Why / When Change Control?
- Physical Changes vs. Document Changes
- Change Control Process
- Change Control Process Model- Integrated Manufacturers
- Change Control Process Model- Sponsor Oversight of CMO Changes
- Types of Changes Subject to Change Control
- Products, Materials, Suppliers, Processes, Facilities, Equipment, etc.
- Like-for-Like Changes
- Emergency Changes
- Case Study # 1- Change Control: Yes or No?
- Change Proposal
- Change Proposal Elements
- Describing the Change
- Case Study # 2- Change Proposal
- Change Justification
- Change Justification Elements
- Change Risk Assessment
- Case Study # 3- Change Justification
- Change Execution Plan
- Change Execution Plan Elements
- Case Study # 4- Change Execution Plan
- Change Proposal Assessment
- SME Assessments (by functional area)
- Case Study # 5- Change Proposal Assessment
- Change Execution
- Key Considerations for Executing Changes
- Evidence of Change Completion
- Change Amendment / Cancellation
- Change Implementation
- Key Considerations for Implementing Changes
- Assessing Change Effectiveness
- Change Control Documentation
- Change Documentation Package Elements
- Putting It All Together: A System Viewpoint
Michael Ferrante
President, Quality and Compliance Associates LLC
Mr. Ferrante is President of Quality and Compliance Associates LLC and has over 40 years experience in the pharmaceutical and biotechnology fields. This experience encompasses quality systems, laboratories, R&D, clinical QA, validation, manufacturing/operations, regulatory affairs, and facilities covering all dosage forms.
During his career, Mr. Ferrante has successfully dealt with over 100 inspections by regulatory agencies, resolved warning letters, prepared and controlled compliance plans at both a site and corporate level. These interactions have occurred both domestically (US) and internationally, since he has dealt in global operations in countries such as Australia, Canada, the Netherlands, Sweden, Brazil, UK, Ireland, Germany, France, Switzerland, Italy, the Czech Republic, India, China, Malaysia, and Thailand.
He has held middle to senior management positions in startup to Fortune 100 companies up to the level of VP of Quality Systems and Compliance. Mr. Ferrante has been asked to give presentations on a number of regulatory and quality topics by the American Society for Quality, the Parenteral Drug Association, International Society of Pharmaceutical Engineers, and the Institute for Validation Technology. He has published articles in the Journal of Validation and Journal of Compliance.
