This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area.
14 Oct 2022
Risk management is becoming increasingly important to drug and medical device development and ensuring compliance with regulatory expectations and during challenging times such as a pandemic. There are now numerous pharmaceutical guidelines covering risk management including ICH Q9, ICH GCP R2, drug and device risk based guidance during a pandemic, regulatory risk based approaches and the ISO standards.
This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area. It will show you how risk management can improve the quality of your development projects and demonstrate the importance of using risk analysis and risk management techniques in the pharma, biopharma and medical device industries. You will learn how to identify, evaluate and implement specific risk-based techniques for risk management, including a quality management framework.
The course will enable you to develop quality risk management principles applicable to pharma, biopharma and device development, as well as to identify and share best practices for risk management tools and approaches.
Anyone who is needs to understand risk management working in the pharmaceutical and medical device industry. Particularly those needing to understand the regulatory expectations, associated guidance and be able to apply different tools and techniques in their role.
Laura Brown (More...)
Dr Laura Brown is an independent pharmaceutical QA, management and training consultant and Senior Lecturer for the MSc in Clinical Research, School of Pharmacy, University of Cardiff. Laura has more than 20 years’ experience of quality assurance and managing international clinical trials including risk identification and management. She has worked for several leading companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International and is an international expert on GCP and clinical trial requirements. Laura was chair of the Institute of Clinical Research GCP Forum for six years and writes regularly on clinical research regulatory requirements.
NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
14 Oct 2022 Live webinar 09:30-17:00 UK (London) |
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14 Oct 2022 Live webinar 09:30-17:00 UK (London) |
GBP 599 499 EUR 859 719 USD 970 814 Until 9 Sep* |
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* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.