Training

•    cGMP

This course provides GMP concepts and key requirements for proper implementation of a GMP program in the pharmaceutical, Medical Device, Biological or biotechnology facility. It deals with specific regulations with respect to the type of industry and compliance with regulatory agencies – Canadian, US, European, Australian and Japanese with an eye on harmonization issues.

•    Process Validation

This course provides a clear understanding of the concepts of Prospective, Concurrent and Retrospective Validation. It stresses the importance of understanding the manufacturing processes and identifying Critical Parameters for setting up of Process controls. Estimate process capabilities and establish Specifications, develop acceptance criteria for validation of the processes involved by applying relevant inferential statistics.

•    Commissioning & Qualification

This course provides an understanding of the integrated approach for User Requirement,
Design, Commissioning and Qualification of Equipment, Systems and Facilities in Pharmaceutical and
Biotechnology industry. It helps understand the relation ships between Design (DS), Functional (FS) and User requirement specifications (URS) with respect to Installation (IQ), Operational (OQ) and Performance Qualification (PQ).

•    Cleaning Validation

This course provides an understanding of Cleaning Validation Master Plans, Product Matrices, Residue Recovery and establishing Limits and Protocols for effective execution of Pharmaceutical and Bio-Pharmaceutical Cleaning Validation.

•    Pharmaceutical Statistics

Pharmaceutical Quality and Validation involves establishing documented scientific proof by way of statistical inferences and predictions. This course provides basic definitions and concepts of statistics - Sample distribution, Probability, through ANOVA, Confidence Intervals (CI), Process Capability and Process Capability Index.