Writing an Effective Standard Operating Procedure (SOPs)

  • Speaker:Dr. Afsaneh Motamed Khorasani, PhD
  • Duration:60Min
  • Product Code:GRC-90409

Live Session - How it works

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  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
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  • Get answer to your queries through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve our Training programs.
  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our support@grcts.com

Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
  • Please click on the link to access the Recording and type in the password provided in the email.
  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

(For more information about our products contact +1- 248-233-2049)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the Recording of the Training for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. 

Use coupon code "GRCTS10" to avail a 10% Discount on your purchase

Certification: GRCTS Attendance Certificate

Description: 

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 You Must 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 

Areas We Will Be covering: 

  • 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: 

  • Anybody who works in a regulated environment (manufacturing, R&D, labs, Lab managers, Clinical trial personnel)
  • All pharmaceutical and medical device companies around the world, including:
  • Regulatory
  • Compliance
  • Audit
  • Quality
  • R&D
  • Scientists
  • Documentation and Validation
  • Clinical Research
  • Lab Managers
  • Engineering and Manufacturing

Instructor: Dr. Afsaneh Motamed Khorasani, PhD 

Dr. Motamed Khorasani 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.

Available Options

Recording: 6 Months Access to the Training which can be accessed from any location

$269

CD-DVD: Shipped within 2 working days

$389

USB - Shipped within 2 working days

$409

5 Member Group: 5 people can Attend the Live Online Meeting from any location globally

$2,849

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$4,569

Recording Access to 10 Members: 10 Participants can access the training Recording for 6 months from any location

$829

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