GMP FastTrack

This is a fast-moving, intensive training course aimed at Managers, Supervisors and Technical Staff working in the pharmaceutical industry.

Course description

As well as establishing the key requirements of GMP, the course focuses on the application of GMP in the working environment.

With a strong regulatory focus on the use of a risk-based and information-driven approach to GMP compliance, delegates will be introduced to a number of science and risk -based management tools, techniques and methodologies.

Course content

• Introduction to GMP
• Managing Quality
• Regulatory Approach to Risk Management – current and future trends
• Documentation and Records
• Contamination Control
• Manufacturing and Packaging GMPs
• PAT & Process Control
• Internal and External Audit Programmes
• Validation

Format

The course consists of a lively mix of presentations, group exercises and discussions. The exercises will be instructor-led, in breakout groups or by self-study. Presentation sessions will be limited to about one hour, with ample time between for delegates to work on the various exercises. The presenter will be available throughout.

At the end of the course, there will be a short quiz to test understanding. Copies (pdf) of all presentation slides and handouts will be provided.

A complimentary information pack containing course details and preparatory exercises will be sent to each delegate prior to the start of the course.

Out of Class Assignment

Delegates are offered the opportunity to complete a GMP assignment following completion of the course. This will be facilitated and supported remotely by SeerPharma’s team of consultants and successful completion will be rewarded with additional certification.

#5311