ComplianceOnline

How to prepare a winning Standard Operating Procedure (SOP)

Instructor: Dr. Afsaneh Motamed Khorasani
Product ID: 705131
  • Duration: 60 Min
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Read Frequently Asked Questions

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.

Why Should You Attend:

A large number of FDA's inspectional observations can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, lack tools to increase compliance with the SOPs and, often are hard for the employees to understand them. They are frequently poorly written, communicated, monitored and enforced.

This webinar will provide step by step instructions to create SOPs for FDA-regulated organizations.

This session will familiarize participants with the basics of how to generate a great SOP. You will learn how to remain compliant and yet not restrict the course of action and how to maintain compliance over the course of the SOP life-time.

Areas Covered in the Webinar:

  • What are SOPs?
  • Why are they Important?
  • What are their Benefits?
  • What are their Limitations?
  • How to create a practical effective SOP (step by step procedure)
  • How to maintain a compliant SOP over the course of its life:
    • Revision/updating
    • Archiving

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
  • Compliance
  • Auditors
  • Quality
  • R&D
  • Scientists
  • Documentation and Validation
  • Clinical Research
  • Clinical Investigators
  • Project Managers
  • Lab Managers
  • Marketing and Promotions
  • Engineering and Manufacturing
Instructor Profile:
Afsaneh Motamed Khorasani

Dr. Afsaneh Motamed Khorasani
Vice President of Medical Affairs, Easy Global Training

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. 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.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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