Change Control for Pharmaceutical, Biotech & Medical Device Industries

Venue: Hilton Montreal Dorval Airport

Location: Dorval, Quebec, Canada

Event Date/Time: May 08, 2006 End Date/Time: May 09, 2006
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Description

AN IMPORTANT TWO-DAY COMPREHENSIVE & INTERACTIVE COURSE & WORKSHOPS ON:

The Change Control Program and Change Process
Change Control Regulations and Requirements
Proposed Amendments
ICH Q7A
EU GMP
Standards ISO, Baldrige, IPEC, PIC
Change Control and Quality Systems
Change Control and Change Management
Implementing a Change Control System
Managing Bottlenecks in your Change Control Process
Change Control SOP’s and Forms
Records Archiving
Scale Up and Post Approval Changes - SUPAC
Principles of Record Management
Change Control in the Laboratory
Changes and Regulatory Submissions
Changes and Materials Management
Changes in Production and Packaging
Changes to Facilities and Equipment
Changes to Configuration Management
Change Control for Software and Computer Systems
Changes by Suppliers and Contractors

Distinguished Course Leaders:

Dr. John G. Lanese - The Lanese Group
Dr. Alan J Smith - Pharmaceutical quality & technology Consulting
Dr. Charlie Sodano - Berlex Biosciences

Who Should Attend?

This 2-day seminar and workshops is directed toward Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biotechnology, Vitamin, Herbal, and allied industries with daily responsibilities in the following areas:

- Change Control
- Change Management
- Quality Assurance
- Quality Control
- Quality Systems
- Quality Management
- Quality Improvement
- CMC
- Engineering
- Validation
- Compliance
- Documentation
- Regulatory Affairs
- Technical Services
- Operations
- Manufacturing
- Production
- Process Management
- Project Management
- Auditing
- Facilities
- Utilities

Venue

12505 Cote de Liesse
Dorval
Quebec
Canada
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