Pharmaceutical Risk Management Training

The Pharmaceutical Risk Management Training Course can be delivered in a hotel, one of our offices, your premises or online via a virtual classroom. The course content can be tailored to meet your requirements. Request a quote for an onsite or online virtual course for an agreed number of delegates from your site.

The Pharmaceutical Risk Management Training Course provides individuals with the chance to investigate how important risk management has now become to the healthcare industry.

Learners will gain an understanding of the regulatory viewpoint, associated guidance and they will have the chance to apply different tools and techniques through a series of case study activities.

• Identify why Risk Management has become important in the regulatory world of healthcare manufacturing
  • Flexible regulatory approach: companies can now determine the most appropriate decisions and actions to take
• Interpret the International Conference for Harmonisation Q9/Annex 20 guidance document
  • Clarification of the EU and FDA perspective including regulatory expectations of a pharmaceutical risk management site process
• 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
  • Understanding the subject of human error
• Consider different methods and documentation for applying Risk Management to daily operations, including HACCP, FMEA and the GAMP®  approach
  • A summary of different approaches to Risk Assessment methods and focus of use, giving examples of HACCP, FMEA and GAMP®’s approach
• Apply Risk Assessment methods to three different case study scenarios:
  • Determine critical control points in a production process using the HACCP tool
  • Determine the corrective actions needed to eliminate, mitigate or control identified hazards in a pharmaceutical manufacturing process using the FMEA tool
  • Determine the level of qualification testing required in a pharmaceutical packaging validation project using the GAMP® 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 or as an online virtual classroom course for an agreed number of delegates from your site. Request a quote.

"Course material and examples very relevant to pharmaceutical filling and packaging - just what I needed."
Napp Pharmaceuticals Ltd

“A new area for me so I have learned when to apply QRM techniques within my department.”
Controlled Therapeutics

“Case studies were especially helpful.”
Controlled Therapeutics

“Well presented, trainer provided information when asked questions.”
Open course delegate

“Good course well presented and good size of group.”
Open course delegate

“Well designed course.”
Sanofi

ITS’ Regulatory Compliance Services’ Manager, Elizabeth Vaughan, has developed extensive knowledge of this specialist area from over 30 years’ industry experience working with Sanofi, Bristol Myers Squibb, Diomed Developments and Vifor Pharma UK. Elizabeth has worked in quality roles within the laboratory and pharmaceutical industry, and gained extensive experience in global quality systems and regulatory affairs, as well as ISO 13485, ISO 9001 and cGMP compliance. Throughout her career, she has been responsible for sharing her knowledge through the design and delivery of a range of training courses for production personnel including Good Manufacturing Practice, Change Control, Deviation Management, Electronic Record Compliance, Validation and Management of API Suppliers/Manufacturers. Elizabeth also has extensive experience in providing quality and GMP training to improve the performance of site quality managers.

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