Why Should You Attend:
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.
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
SpeakersDr. 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. Before joining this company, Dr. Motamed Khorasani has served as an independent consultant, director of medical affairs, senior medical sciences liaison, senior scientist and senior medical analyst at Merck (MDS), Johnson & Johnson, United States Pharmacopeia Convention (USP), Amgen, Baxter International, Covidien (eV3), Radient Pharmaceuticals, AMDL Diagnostics, Microbix Biosystems, Neometrix Consulting, Mount Sinai Hospital, Princess Margaret Hospital, and Vancouver General Hospital.
She has more than 20 years of experience and many National and international certificates in GLP, GMP, ICH-GCP and global regulatory compliance for clinical trials and is a member in a number of professional associations, including: American Association of Cancer Research (AACR), American Medical Writers Association (AMWA), Regulatory Affairs Professional Society (RAPS), American Society of Quality (ASQ), Project Management Institute (PMI), and Intellectual Property Institute of Canada (IPIC). Dr. Motamed Khorasani's research has focused on high throughput approaches in the context of cancer informatics with a particular interest in the use of comparative analysis for the mining of integrated oncology datasets that include protein-protein interaction and gene expression profiling. She has published and presented more than 50 papers, abstracts and articles in highly regarded scientific journals and high profile conferences and scientific meetings.
Who Should Attend
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