Implementing a Change Control Quality System Successfully
This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution, and final implementation. The importance of proper planning, critical thinking skills, and coordination of all change activities will also be discussed.Learning ObjectiveIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrate how to write/execute a Change control proposal, assessment, and closeoutDiscuss the Establishment of a change control boardAreas CoveredOverview of change control regulatory requirements What is change control? and why change control? Types of changes subject to change controlLike for like Specification changesFacility changesEquipment changesEmergency changesChange control proposalProper documentationElements to be includedChange assessment (Risk, Impact) and approval to executeImpact on productsImpact to facilityImpact on regulatory filingsChange control board development Areas of responsibilities for board membersEstablishing action itemsEstablishing deadlinesFinal implementation of change - How to close out a changeEffectiveness of the changeChange control documentation - Hard copy systems - Electronic systemsWho Should AttendPharmaceutical professionals involved in the manufacture of productsAll levels of managementQuality professionals
This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution, and final implementation. The importance of proper planning, critical thinking skills, and coordination of all change activities will also be discussed.
Learning Objective
- Identify what constitutes a change
- Learn how to properly categorize a change
- Demonstrate how to write/execute a Change control proposal, assessment, and closeout
- Discuss the Establishment of a change control board
Areas Covered
- Overview of change control regulatory requirements
- What is change control? and why change control?
- Types of changes subject to change control
- Like for like
- Specification changes
- Facility changes
- Equipment changes
- Emergency changes
- Change control proposal
- Proper documentation
- Elements to be included
- Change assessment (Risk, Impact) and approval to execute
- Impact on products
- Impact to facility
- Impact on regulatory filings
- Change control board development
- Areas of responsibilities for board members
- Establishing action items
- Establishing deadlines
- Final implementation of change
- How to close out a change - Effectiveness of the change
- Change control documentation
- Hard copy systems
- Electronic systems
Who Should Attend
- Pharmaceutical professionals involved in the manufacture of products
- All levels of management
- Quality professionals
