How to Write Effective Standard Operating Procedures (SOPs) Workshop

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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.

Course Outline

• 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.