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Ref : 32519
Event :Change Control Best Practices - Avoiding Unintended Consequences of Changes

Dates :Thursday January 28th, 2021 - Friday January 29th, 2021

Location :San Jose, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

Editorial

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.
 

Objectives

  • 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

Program

Day 01(6:00 AM to 12:00 PM PST)
  • 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
Day 02(6:00 AM to 12:00 PM PST)
  • 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


 

Speakers

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.


 

Organizing committee

Complianceonline
 

Location

Map and directions
Conference address :
San Jose
United States
tel : +1-888-717-2436
Map and directions

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Details

Change Control Best Practices - Avoiding Unintended Consequences of Changes Pharmacy
change control process, change execution plan, fda change control expectations, change control best practices, change control procedure fda, fda guidance change control, fda management of change, fda document control
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