Abstract:
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.
Course Outline:
- What is an SOP?
- Why do we need SOPs?
- When do we need SOPs?
- Roles and Responsibilities
- Sections of an SOP
- Writing Tips
- How SOPs are Written
- Change Control
- Maintenance
- SOP Workshop
Who Should Attend:
This 2-hour webinar is targeted at anyone involved in the organization, writing or management of SOPs required for GMP, GPP, GVP or GCP purposes.
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