How to prepare a winning Standard Operating Procedure (SOP)

Description

winning Standard Operating Procedure

Speaker’s Bio:

Dr. Afsaneh Motamed Khorasani is a Medical and scientific Affairs expert and a Senior Scientist. Moreover, she has a strong background in biomedical science and clinical trial/research. Also, 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. Furthermore, she is the Vice President of Medical Affairs at Easy Global Training, a US-based firm providing global regulatory, quality, and medical affairs training backed by consulting.

Formerly, she 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. Also, she has many National and international certificates in GLP, GMP, ICH-GCP, and global regulatory compliance for clinical trials. Furthermore, she is a member of several professional associations, including the 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).

Her research has focused on high throughput approaches in cancer informatics. Moreover, her particular interest was in using comparative analysis for mining integrated oncology datasets that include protein-protein interaction and gene expression profiling. Furthermore, she has published and presented more than 50 papers, abstracts, and articles in highly regarded scientific journals, high-profile conferences, and scientific meetings.

On-Demand Webinar Overview

Standard Operating Procedure (SOP) ensures a certain level of consistency and quality within the organization by providing standardized procedural instruction to perform a task with the right people trained. Also, it is a way of sharing Best Practices for a specific job and an excellent tool for managing the workplace. Moreover, regulatory bodies and electronic records compliance require that the organizations have formal documentation (SOPs) describing their business, quality, and compliance practices. Therefore, producing an effective SOP is the first step to complying with different regulations relevant to product manufacturing.

Learning Highlights

• After completing this 60-minute On-Demand Webinar, you will gain a moderate/advanced knowledge of the definition, purpose, importance of SOP, Pros and cons of SOPs, the steps to develop an SOP, and finally, a template for your future use.
• The outline of this 60-minute On-Demand Webinar includes:
  • What are SOPs?
  • Importance
  • Benefits
  • Limitations
  • How many SOPs are needed?
  • SOP topics and some examples
  • Steps to develop an SOP and the thought process around it:
    • Process mapping
    • Authoring
    • Formatting and language
    • Editing
    • Authorizing
    • Distribution
      • A model for preparation/distribution scheme
    • Training
    • Implementation
    • Revision / archiving (Version Control)
  • Example of an SOP life cycle in the laboratory
  • A template for SOP
  • Summary
  • References

Who Can Benefit From This Course

• Anybody who works in a regulated environment
• Manufacturing & Production Personnel / Managers
• Research and Development Personnel (R&D) / Managers
• Quality Assurance & Quality Control Personnel / Managers
• Laboratory Personnel / Managers
• Validation Specialists
• Clinical trial personnel
• Project Managers

Details

• ID:                                     1348
• SKU:                                 OW-0005-BP
• Type:                                On-Demand Webinar
• Format:                            Video MP4 Play Back
• Date of Last Update:    Jan 10, 2017
• Duration:                         60 minutes
• Course Level:                 Intermediate / Advanced
• Price:                               $199.00

Notes

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