Training & Events

How To Write An Effective Standard Operating Procedure (SOP)

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BAM is pleased to partner with Pharmaceutical Sciences Group to help offer regulatory training for our members.

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.

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. 

The course emphasizes practical issues such as:

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

The course materials and access link will be sent to all registrants closer to the webinar date.
 
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.

Date: February 25, 2021

Time: 1:00 pm to 3:00 pm CST

Member Pricing: $125.00

Non-Member Pricing: $210.00

*** To register contact BAM's Training Coordinator Sheri Huetter at sheri@biomb.ca

The deadline to register is February 22, 2021.

Course Leader


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

Pauline McGregor, Ph.D. CChem MRSC has over 30 years of experience in the pharmaceutical industry. She is an expert in quality systems and procedures, GMP regulations, and analytical chemistry.  She has utilized her skill set globally in the UK, Canada, US, Jordan, Brazil, and China and has helped companies prepare for a GMP inspection to gain their European/Health Canada/FDA GMP licenses. She is often asked to perform self-inspections for companies as an extension of their quality group.

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.

As a USP volunteer, Pauline was a proud member of the initial USP expert panel for Validation, Verification, and Transfer of Analytical Procedures and a member of a USP Chemical Medicines Monograph expert review committee. She continues to be a USP expert volunteer. Pauline is also a member of The Royal Society of Chemistry, UK, and is listed on their current directory for consultants.

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