This course is a Toronto based, hands on interactive training concerned with principles and recent advances in Good Manufacturing Practice (GMP) and its implementation in Pharmaceutical industry. The pharmaceutical industry operates in a multibillion market place and its operations are highly complicated and so too its governance and regulations. Keeping eye on GMP is a key step in being able to get authorized to export or even market the pharmaceutical products. Based on that, this course aims to qualify the participants to understand and properly implement the regulations and the guidelines of GMP designed by different regulatory authorities.

Course Content (Brief)

Basic Components of GMP

• General requirements
• Organizational units
• Key roles
• Building management
• Facilities management
• Quality risk management

GMP guidelines

• WHO GMP guidelines
• International conference on harmonization ICH-GMP guidelines
• EU-GMP guidelines
• FDA-GMP guidelines
• Pharmaceutical Inspection Corporation Scheme (PICS)
• GMP standards in some other countries ( Australia, Canada, Singapore etc)
• International organization Standards (ISO)

The trend towards harmonization of pharmaceutical regulations

Validation and qualification

• Validation master plan
• Validating processes
• Qualifying equipment
• Design Qualification
• Installation Qualification
• Operational Qualification
• Performance Qualification

Documentation

• Essential Documents Specifications
• Specifications for starting and packaging materials
• Specifications for intermediate and bulk products
• Specifications for Finished Products
• Formula and Processing Instruction
• Batch Processing Records
• Batch Packaging Record
• Procedures and Records

Audits

• The audit process: Planning, documentation and corrective actions
• Internal audits: Audit schedule
• Supplier audits

Date of the workshop: 17^th-19^th  Oct  2018             Avenue: Toronto, Canada