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
2 Dec 2019
& 25 Jun 2020 , 3 Dec 2020
GBP 699 599 *
EUR 979 839 *
USD 1,090 934 *
* When you book before 24 Oct
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 SOPs which can easily be understood by the end users.
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 firstname.lastname@example.org
How to write concise and user friendly SOPs
Review the fundamentals of SOPs
Write concise and user-friendly SOPs
SOP implementation and management
Ensuring your SOPs meet regulatory requirements
Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), 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 and regulatory requirements in clinical trials in the pharmaceutical industry. She has worked in senior positions for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality systems including data protection and data integrity in clinical trials. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on pharmaceutical regulatory issues in clinical trials
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.
|2 Dec 2019|
|2 Dec 2019||Rembrandt Hotel, London||GBP 699.00
+ VAT @ 20.00%
Until 24 Oct*
|25 Jun 2020|
|25 Jun 2020||Rembrandt Hotel, London||
+ VAT @ 20.00%
|Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.|
|3 Dec 2020|
|3 Dec 2020||Venue not yet confirmed||
+ VAT @ 20.00%
* Note the early booking discount cannot be combined with any other offers or promotional code