|
|
| Begins |
September 22, 2008
|
|
|
|
|
|
|
|
| Email |
enquiry@ipacanada.com
|
|
| Category |
Health: Medicine
|
|
| Category 2 |
Health: Professions
|
|
| Category 3 |
Health: Pharmacy
|
|
|
|
|
|
|
|
|
|
| Description |
Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Manufacturers
A TWO DAY COMPREHENSIVE & INTERACTIVE COURSE, WITH CASE STUDIES & WORKSHOPS ON:
- Regulatory Expectations for Computer System GxP Compliance
- Preparing for an FDA Inspection and Review of Common 483’s
- Requirements for a Successful Validation Project
- Software Validation Methods, Design, Development, Verification
- Performing IQ/PQ/OQ Requirements and Documentation
- Validation for Off the Shelf (OTS) Software and Custom Programs
- Achieving Traceability in the Validation Process
- Meeting User Requirement Specifications (URS)
- Applying Risk Management and Risk Based Approach
- Change and Configuration Management Procedures
- Prioritization of Systems and System Maintenance Procedus
- Managing Spreadsheets, Production and Lab Equipment
- System-Level Validation Testing
- System Maintenance for Security
- Traceability and Archiving
- Strategies for Vendor Auditing
- Documentation Management
Interactive Sessions:
- Performing a Self Audit of GxP Computer Systems
- User Requirement Specifications (USR) Evaluation
- Validation for Laboratory Information Management Systems (LIMS)
|
|
|
|
