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“The Compliance Certification Board (CCB)® has approved this event for up to 13.8 live CCB CEUs. Continuing Education Units are awarded based on individual attendance records. Granting of prior approval in no way constitutes endorsement by CCB of this event content or of the event sponsor.”
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
In-Person Seminar going Virtual with increased learner satisfaction.
Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
- The real-time and live presentation as in in-person events
- Private chat for company-specific conversation – the same as you would get in an in-person seminar
- Opportunities to connect with your peers to share knowledge at a different time and have group discussions
- Live workshop activities
- Live Q&A during the event and offline Q&A assistance after the event
- As usual more content, activities and case studies and now adding homework for a comprehensive understanding
- Certification
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
Andrew Campbell
Pharmaceutical 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.
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Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).Cancellations and substitutions for In-person Seminars:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Cancellations and Substitutions for Virtual Seminars & Webinars:
Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice. Offers:Testimonials
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