Implementation & Management of a Compliant CHANGE CONTROL Program - May 2-3, 2005 - Toronto, Canada

Implementation & Management of a Compliant CHANGE CONTROL Program
May 2-3, 2005 - Toronto, Canada
Hilton Toronto Airport
Who Should Attend?
This program is specially designed for Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biotechnology, Vitamins, Herbals, and allied industries with daily responsibilities in the following areas:
Quality Assurance
Quality Control
Analytical Laboratories
Compliance Auditing
Data Review
Regulatory Affairs
Change Control
Stability
Validation
Operations
Documentation and Technical Writing
Manufacturing
Training
Consultants
Contract Services
GXPs
A ONE & HALF A DAY COMPREHENSIVE & INTERACTIVE COURSE,
WORKSHOPS & CASE STUDIES ON:
Regulations and Requirements
Change control as critical part of the validation life cycle
How to set up Change Control, Documentation Systems
Preparing Change Control SOPS & Forms
Processes involved to efficiently control and document changes to:
- Manufacturing processes
- Facilities
- Product
Elements of Change Control Management
Change Control process for computerized systems
Change Control in Medical Device industries
How to organize change documentation to withstand regulatory queries during field inspections?
What functions a Change Control system must perform
How the organizational culture can affect the successful implementation of Change Control
Types of Change
Different levels of change (major, minor, critical) and distinguishing them
Types of reviews and approvals
Roles and Responsibilities
Signature meanings
How your Change Control system may be examined by investigators
Change Control checklists
Personnel Training
Scale Up and Post Approval Changes - SUPAC
WORKSHOPS & CASE STUDIES ON:
Preparing Change Control SOP
Preparing Change Control Form
Case Studies
Review of FDA recent 483s on Change Control - Examples of Noncompliance