How to Write Effective Standard Operating Procedures (SOPs) Workshop
March 22, 2019
9:00 a.m – 4:30 p.m.
CAD $585.00 + HST
AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Instructor and Program Chair
Deborah Gordon, B. Sc., Dip. Pharm. QA, began her career in the Sciences as a Forensic Analyst working on crime scenes and in the lab analyzing evidence to be presented in court. Her attention to detail, which was critical to crime scene investigation, eventually led her to the Quality Assurance field. Her experience as a Forensic Analyst paved the way for her career growth. In 2008, Deborah completed her training as an Auditor by successfully passing the American Society for Quality Auditor examination, (ASQ, CQA).
Deborah has 16 years of experience in the pharmaceutical industry, including 15 years of auditing experience. Her extensive experience includes warehouse logistics, storage and distribution, wholesaling, importing, packaging/labelling and manufacturing of pharmaceuticals. She has done extensive work in temperature mapping of warehouses, coolers, freezers and stability chambers. As a leader in pharmaceutical quality assurance, she also enjoys the challenge of auditing, training and motivating employees.
Regulatory Agencies require written procedures for all systems and operations which impact the quality and safety of pharmaceutical products. SOPs provide the main forum for the documentation of a Company’s systems, processes and operations. SOPs are therefore the most popular documents audited by Regulatory Agencies during GMP inspections to ensure they reflect current practices that follow regulatory requirements and they are followed as written.
Effective SOPs lead a company not only to consistency, quality and compliance but also to executing 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 that the SOPs had not been followed or did not reflect current or acceptable practices.
This course is designed to provide helpful information and essential training towards achieving effective SOPs. It includes topics relevant to the writing, formatting, execution and management of SOPs and relates to the role which SOPs play in achieving the required level of compliance and quality.
Participants may bring an SOPs related to their work for the group session where individual questions will be addressed.
- The role of SOPs with respect to GMP operations, Quality Systems and documentation
- When do you need an SOPs?
- Reviewing current SOPs to determine gaps and overlaps to strengthen the existing systems and improve efficiency and compliance.
- Designing an SOPs template to optimize the flow of the procedure
- Formatting of SOPs
- The team approach to SOPs writing, defining responsibilities and knowing the audience.
- Writing tips on how to keep the document concise, unambiguous and accurate.
- Managing revisions and deviations
Interactive exercises include
- The benefits of SOPs
- The logical approach to defining the SOPs procedure
This course will deliver the tools to enable you to:
- Understand the critical role SOPs play in daily operations
- Strengthen and maintain your current SOPs system
- Write an effective SOPs by
- Using the correct language
- Capturing the flow of the procedure
- Consulting with the appropriate people
- Organise effective training for SOPs
Who Should Attend
This one day course is targeted at personnel from Quality Assurance, Production, Quality Control, Regulatory Affairs and other departments who are involved in the organization; writing or management of SOPs required for GMP purposes.
Certificate of Attendance and Course Material
- All participants will receive a certificate of attendance upon completion of the course.
- The participants will be receiving specially prepared course manual.
Registration Fee Includes
Presentation Materials, Luncheon, Refreshment and Free Parking (Please indicate any special Dietary requirements when registering for the course)
Note: Registration closes one week prior to the start of workshop.