Training & Events

BAM Members please contact Sheri Huetter at sheri@biomb.ca to register for subsidized pricing.

Important: The webinar is in Eastern Standard Time.

This webinar is designed to provide guidance to assist with the writing of effective SOPs. It covers each individual section of the SOP. Common errors when writing SOPs, the team approach to SOP writing and how to write in simple language and avoid ambiguity is also discussed.

Standard Operating Procedures (SOPs) provide the main forum for the documentation of a Company’s systems and operations. SOP’s are therefore the most popular documents audited by Regulatory Agencies during inspections to ensure they reflect current practices and are followed as written. 

Effective SOPs lead a company not only to consistent outcomes, quality and compliance but also help to execute efficient business operations. Often SOPs are written without consultation with the end user or by someone who has good writing skills but little experience of the topic. They can include too much information, making them difficult to follow or too little detail causing them to be ambiguous. Such SOPs can lead to audit observations, inefficiency in business operations and inconsistent outcomes for the described tasks.

The course emphasises practical issues such as:

The team approach to SOP writing, defining responsibilities and knowing the audience.
Designing an SOP template
Ensuring the flow of a process within the document
Writing tips on how to keep the document concise, unambiguous and accurate.

Who should attend:

This webinar is targeted at personnel from Quality Assurance, Production, Quality Control, Regulatory Affairs and other departments who are involved in writing, reviewing or management of SOP’s.

 

Course Leader
Dr. Pauline McGregor, Ph.D. Chem, MRSC

Pauline has fulfilled a variety of roles in her thirty years in the pharmaceutical industry, including working with large Pharmaceutical corporations as well as contract testing laboratories in Canada and the UK. Pauline completed her honours degree and PhD in photo organic chemistry in Scotland, where she also taught analytical techniques to undergraduate students. On completing her PhD in 1995, she came to Canada to conclude her post doctoral studies at the University of Western Ontario.

Pauline has taught analytical R&D, method validation, GMP and related Quality Systems courses across Canada, in the USA, Jordan and China. Throughout her career, she has identified a lack of shared knowledge between Manufacturing, Quality Control, R & D and Quality Assurance sectors in the Healthcare Industries. She believes there is a need for cross education and training to allow the different disciplines to communicate with each other so that realistic objectives can be met by all in a timely manner with a harmonized understanding. Pauline is a member of The Royal Society of Chemistry, UK, is listed on the RSC Directory of Consultants. She is also on a USP Expert Committee for monograph review and on the USP Expert Panel for validation, verification and transfer of analytical procedures.

https://psg.ca/events/how-to-write-effective-sops/