Computer Systems Validation (CSV), Data Integrity, 21 CFR Part 11 Compliance and GAMP 5

Description:

This new 2-day Seminar on Computer Systems Validation provides participants with knowledge and tools to effectively use, monitor, control, and assure the integrity of electronic data and computerized systems. The presenter - Mr. KR Vaghela will help you explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.

The course not only ensures a full understanding of the regulations and guidelines for raw data and other records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations.

Areas Covered:

• Role of FDA
• Computer Systems Validation Points
• Why Validation?
• Benefits of Validation
• GAMP 5
• 21 CFR Part 11 Compliance
• Annex 11
• Data Integrity
• Related Warning Letter Points
• Computer Systems Validation Deliverables
• Risk Assessment ….and More

A must attend seminar for professionals in:

• Pharmaceutical Development Companies
• Quality Control Laboratories Companies
• Quality Departments of API Manufacturers
• Quality Departments of Finished Product Manufacturers
• Medical Device Companies
• Biotech Companies
• Contract Laboratories
• Clinical Research Organisations
• Suppliers and Service Providers of Instruments and Computer Systems
• Every Company that needs to comply with FDA Regulations

For full details and complete AGENDA:

http://compliancetrainings.in/product/computer-systems-validation-csv-data-integrity-21-cfr-part-11-compliance-gamp-5