How to Prepare a Standard Operating Procedure (SOP)?

07 Jul 2022
10:00 AM PST | 01:00 PM EST
60 Minutes

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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.

In this webinar join expert speaker Afsaneh Motamed Khorasani, who will instruct the participants on 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 lifetime

AREA COVERED

  • 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
  • Authoring
  • Formatting and language
  • Editing
  • Authorizing
  • Training
  • Implementation
  • Revision / archiving (version control) An SOP example and template

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
  • 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 lifetime
  • 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
  • Authoring
  • Formatting and language
  • Editing
  • Authorizing
  • Training
  • Implementation
  • Revision / archiving (version control) An SOP example and template

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
Webinar Option
Live + Recorded Session
Live + Transcript
Live + Training CD
Transcript (PDF Transcript of the Training)
Downloadable Recorded Session
Training CD
Group Session Participants + Recorded

Live Session for 10 Participants (For adding extra attendees please contact our Customer Support Team)

Speaker Profile

ins_img 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. Before joining this company, Dr. Motamed Khorasani has served as an independent consultant, director of medical affairs, …

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