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GMP, GAMP® & Validation Training > Pharmaceutical Risk Management Training > Pharmaceutical Risk Management Training


Pharmaceutical Risk Management Training

Course Title:Pharmaceutical Risk Management Training
Course Delivery:

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.

Course Duration:1 day
Course Overview:

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.

Course Content:
  • 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/



Open Course Dates:
Pharmaceutical Risk Management Training
15 July 2021, Newcastle, £577+VAT per learner.
Pharmaceutical Risk Management Training
14 October 2021, Near Manchester Airport, £577+VAT per learner.
 
 

GROUP BOOKING DISCOUNT - Book more than one place on an open course and receive the following discounts:

  • 10% discount on second place
  • 20% discount on third place
  • 25% discount on fourth place

Group booking discounts cannot be used in conjunction with any other offer.

Cost includes tuition, lunch and training materials. Download a printable version of the Booking Form and Terms and Conditions.

Onsite Courses:

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.

Testimonials:

"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 Tutor's Experience:

ITS’ Regulatory Compliance Trainer, Dr Jennifer Thompson, has over 20 years of experience in the pharmaceutical sector in computer systems validation and IT infrastructure controls and compliance and has delivered projects for a wide range of companies in the UK, EU and USA including GlaxoSmithKline, Novartis Healthcare, Lonza Biologics, Elan Pharmaceuticals, Hoffman LaRoche and others. Her experience covers computerised systems used in manufacturing, laboratories, enterprise systems and clinical trials management. She has written articles and given presentations on a wide range of topics and contributed to the GAMP® Good Practice Guide “A Risk-based Approach to GxP Process Control Systems” and “The Risk Based Compliance Handbook” by Siegfried Schmitt (Paraxel).

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Further Information:
Request more information on this training course.



Course Calendar:


 


Contact our team today

For further information, please contact
our team on +44 (0)1642 222232 or
email enquiries@its-ltd.co.uk