Audience

Suitable for all laboratory staff working in an environment covered by the requirements of GMP and GCLP (Good Control Laboratory Practice).

Duration

1 day

Objectives

By the end of the course you will:
• Have knowledge of the expectations of the regulators in operating control laboratories
• Understand the unique role of testing laboratories in the pharmaceutical environment
• Be able to prepare for regulatory or customer audits

Content

The pharmaceutical quality control laboratory serves one of the most important functions in the manufacturing environment. Many of the GMP regulations and guidances apply to control laboratories but in particular Chapter 6 (QC and Good Control Laboratory Practice) of the EU Guide to GMP. The course also covers the role of documentation, pharmacopoeias, laboratory reference standards, calibration, calculations and results.
The final session of the course brings all this together by a session on preparing for regulatory inspection.

• Good Manufacturing Practice
• GMP, QC & GCLP
• Sampling and Testing
• Documentation - What are the GMP Requirements?
• Documentation Situations
• Calculations, Results and OOS
• Control of Standards and Reagents
• Equipment Qualification & Calibration
• Test Method Validation
• Stability Testing
• Preparing for Regulatory Inspection

Cost

Non-Member - £695 + VAT
One Nucleus Member* – £556 + VAT 

*Please email training@onenucleus.com for the ON member discount code.

Training provided by

Tel: 0118 918 4076
Email: bookings@rssl.com