This course provides individuals with the chance to investigate how important risk management has now become to the healthcare industry, particularly in terms of validation of systems and equipment.

The Risk Management & Validation (1 Day) Training course investigates why risk management has become such a hot topic, and considers the corresponding guidance from the FDA, EU and GAMP®. Learners will have the opportunity to sample different risk assessment models and practice on validation case study scenarios.

• Identify why Risk Management has become important in the regulatory world of healthcare manufacturing
• Interpret the International Conference for Harmonisation Q9/Annex 20 guidance document
  • Clarification of the EU and FDA perspective
• Learn how Risk Management could work for your organisation
  • Determine the success criteria for utilising Risk Management
  • Risk Management teams, roles, strong leadership, documentation and likely pitfalls
• Investigate GAMP® 5’s interpretation of Risk Management and its application through the life cycle for computerised systems, including the potential approach for equipment
• Consider different methods and documentation for applying Risk Management to daily operations, including FMEA and the GAMP® approach
  • A summary of different approaches to Risk Assessment methods and focus of use giving examples of FMEA and the GAMP® approach
• Apply Risk Assessment methods to different case study scenarios such as:-
  • At URS development stage
  • Supplier assessment capability
  • Determining GAMP® categories of software for process control and other systems
  • Scaling qualification activities based upon FAT activities/results
  • Using as part of change control activity for scaling verification activities
  • Utilising risk assessment when following the ASTM E2500 approach

ISPE owns the GAMP® trademark http://www.ispe.org/

This course can be delivered to a group of up to 12 delegates at your premises. Request a quote for an onsite course.

ITS offers onsite training courses delivered by an English-only speaking trainer for companies in Europe and Worldwide. ITS has delivered courses to delegates from a number of countries including Belgium, France, Germany, Ireland, Jordan, Russia, Sweden and Switzerland.

ITS’ Regulatory Training Manager, Alan Benbow, has developed extensive knowledge of this specialist area from 22 years’ industry experience working with Johnson & Johnson, and Wyeth Pharmaceuticals.

During his 14 years at Wyeth, Alan was involved in a wide range of activities including, at operational levels, developing operators, craftsmen, and technicians; he was also responsible for training and assessing operational employees to NVQ standards. From a mid-management perspective, training and development initiatives included facilitating continuous improvement projects and best practices, and receiving internal recognition awards. more ›