An essential course for ensuring compliance with Regulatory Requirements which will be of particular relevance for Pharmacovigilance, Regulatory Affairs, Clinical Research/Operations, GMP, QA and Document Management Functions
25 Jun 2020
& 3 Dec 2020
SOPs play a crucial compliance role with regulations. It is therefore essential that they are well written and easy to use by the end users. If SOPs are not followed correctly, the validity of data generated is compromised, leading to inspection findings and non-compliance issues which could lead to delays in bringing a drug/device to market.
This SOP course has been specifically designed to help you develop the skills to write and produce the content of SOPs using a best practice process, review and implement SOPs and
ensure you comply in a regulated environment.
You will come away with the confidence to use a process to write, update and implement effective SOPs.
Please note we are also running:
This meeting runs back-to-back with Improving Processes and CAPA (Corrective and Preventative Action) and there is a further £100/€140 discount off when booked together.
To find out more call Customer Services on +44 (0)20 7749 4730 or e-mail email@example.com
Fundamentals of effective SOPs
Write concise and user-friendly SOPs
SOP implementation and management
Ensuring your SOPs meet regulatory requirements
Dr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including “The Planning of International Drug Development”, in the Clinical Research Manual, Euromed and the “Impact of Brexit”, RQA Journal 2017.