Dr. Afsaneh Motamed Khorasani, PhD, is a Medical and scientific Affairs expert and a Senior Scientist with a strong background in biomedical science and clinical trial/research. She has a tenured and diverse range of experience in medical affairs, basic and industrial clinical research and develop Read more
Standard Operating Procedures (SOPs) are required for companies that are regulated. However, there is no guidance available by regulatory bodies on how to write, maintain, and update SOPs. Often, SOPs are prepared in a way that makes compliance difficult, leading to errors or delays that will be discovered during an audit. Technically, all FDA inspections include an SOP review and it is very important to have them designed such that they are easy to maintain and update.
• After this webinar, you will become familiar with the basics of how to generate a great SOP
• How to remain compliant and yet not restrict the course of action
• How to maintain the compliance over the course of the SOP
• Record compliance with examples
• What are SOPs?
• Why are they Important?
• What are their Benefits?
• What are their Limitations?
• Important types of SOPs
• Minimum number for SOPs, Topics, and examples
• SOPs and Guidelines
• Steps to develop an SOP:
o Process mapping
o Formatting and language
o Revision / archiving (version control)
o An SOP example and template
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
Manufacturers of Medical devices, Pharmaceutical products, Dietary supplements and Food ingredients, Laboratories and Clinical Research. The following titles will benefit:
• Regulatory Affairs
• Documentation and Validation
• Clinical Research
• Clinical Investigators
• Project Managers
• Lab Managers
• Marketing and Promotions
• Engineering and Manufacturing