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:
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.
Seminar Fee Includes:
- AM-PM Tea/Coffee
- Seminar Material
- USB with seminar presentation
- Hard copy of presentation
- Attendance Certificate
- $100 Gift Cert for next seminar
- Download Brochure
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
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.
Day One (8:30 AM - 4:30 PM)
Registration Process: 8:30 AM - 9:00 AM
Session Start Time: 9:00 AM
A. Regulatory Requirements
B. FDA Change Control Expectations / Warning Letter Examples
C. Purpose of Change Controls
- What is Change Control?
- Why Change Control?
- A Different Way of Thinking
D. Change Control Process Model
- 5 Part Process Model
- Key Terms and Definitions
E. Types of Changes Subject to Change Control
- Products, Materials, Suppliers, Processes, Facilities, Equipment, etc.
- Like-for-Like Changes
F. Change Proposal
- Current State / Proposed State
- Group Exercise - Change Proposal
G. Change Justification
- Science and Compliance Rationale
- Group Exercise - Change Justification
H. Change Execution Plan
- Key Elements
- Group Exercise - Change Execution Plan
I. Change Proposal Assessment
- Risk Assessment
- Validation, Technical, Regulatory, Quality Assessment
- Group Exercise - Change Risk Assessment
Day Two (8:30 AM - 4:30 PM)
A. Executing the Change
- Key Elements
B. Implementing the Change
- Key Elements
C. Change Control Documentation
- Key Elements
D. Putting It All Together: A System Viewpoint
E. Change Control Workshop
- Participant Teams to Write-Up Mock Change Control, Based on Case Studies Provided by Trainer
Mr 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 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.
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