Evaluating Risk Using HACCP

£535 + VAT

10th July 2008

Hazard Analysis and Critical Control Point (HACCP) principles have been used as the key tool for achieving product safety through hazard identification and control in the food industry for over 40 years.  Its use in the Pharmaceutical Industry has been somewhat limited, but its value and importance has been gaining increased momentum in the past few years.  The Food and Drug Administration (FDA), for example, are moving towards risk management and the use of HACCP as a key tool for focusing and improving GMP compliance.  In addition, the concept of risk assessment and analysis are pivotal parts of the new EU GMP Annexes 15 and 17, covering "Qualification and Validation" and "Parametric Release" respectively.  HACCP has also been used for many years in the Medical Device Industry for assurance that their Critical Control Points are in control.

HACCP has a risk based preventative approach, which makes it a powerful tool for managing product safety.  It can, amongst other things, highlight areas where effort must be focused during, for example, process validation studies, In-Process Control testing, product packaging, contamination control, staff training and environmental monitoring.

Course Content:

• What is HACCP and what benefits does it have?
• The origins of HACCP and its use in the Pharmaceutical Industry
• Identification of hazards and risk assessment
• Establishing and validating critical limits
• Establishing control & monitoring procedures
• Putting the HACCP plan into practice
• HACCP validation & verification
• HACCP documentation
• Making HACCP work

To book a training course, please download the booking form, complete and email to bookings@rssl.com