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.
This webinar will instruct the participants how to write, maintain, and update SOPs to ensure compliance.
Why Should You Attend
- 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 life time
• 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:
• Process mapping
• Formatting and language
• Revision / archiving (version control)
• An SOP example and template
Who will Benefit
Anybody who works in a regulated environment (manufacturing, R&D, labs, Lab managers, Clinical trial personnel)
Industries who can attend
This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel
Faculty Dr. Afsaneh Motamed Khorasani
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 development, clinical trials, Medical and regulatory writing and intellectual property. She is currently the Vice President of Medical Affairs at Easy Global Training, which is a US-based firm providing global regulatory, quality and medical affairs training backed by consulting.