Standard Operating Procedure e-Book (Step-by-Step Guide)


ID:          1351
SKU:      EB-0001-MQ
Type:     e-Book


In this 27-page comprehensive guide (Standard Operating Procedure e-Book), you will learn how to produce an effective SOP. We have included a proposed structure for an SOP as well as draft language and other guidance to assist you in creating a good SOP.


Authors’ Bio:

Dr. Afsaneh 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.

This Standard Operating Procedure e-Book is designed to provide an overview of SOP and a step-by-step guide to enable you to design your own SOPs, along with a sample of an SOP to show you all the items that are supposed to be included in one. Standard Operating Procedure (SOP) is used to ensure the presence of a certain level of consistency and quality within the organization by providing a standardized procedural instruction to perform a task with the right people trained for it.

In this comprehensive guide (Standard Operating Procedure e-Book), you will learn how to produce an effective SOP. Furthermore, we have included an MS Word template to be used as a starting point for preparing a standard SOP. We have included a proposed structure for an SOP as well as draft language and other guidance to assist you in creating a good SOP. We have saved this template in different formats (.docx, .dotm, .dotx, .docm, .doc, and .dot) to make sure it is compatible with all systems.

Learning Highlights
By reading / following this Standard Operating Procedure e-Book, you will be able to:

  • Define the standard operating procedure
  • Define manual of operation (MOP) and how to differentiate it from SOP
  • Understand the importance of SOPs as applicable to your specific work environment (explaining the top ten reasons for receiving warning letters from regulatory bodies, three of which are SOP-related)
  • Understand their benefits and limitations
  • Understand the 8-fold process of creating an effective SOP (Process mapping, authoring, formatting, editing, authorizing, distribution, training, implementation, and revision / archiving)
  • Have an example of a template for your SOPs
Please note that in the SOP template provided with this Standard Operating Procedure e-Book:
  • The yellow-highlighted text enclosed with [ ] indicates a placeholder where a specific detail is to be inserted (replace as appropriate).
  • Ensure that all placeholders and example text is replaced with the function-specific information.
  • In the template, the instructions and explanatory text are indicated by <blue italics>, which is used for explanations only and must not be included in the final document.
  • Please review this template and feel free to adapt it to the specific needs and requirements of the monitoring group and study.
  • The logo of the Institution must be used on this form.
  • Leave the template version information in the document
Who Can Benefit From This Standard Operating Procedure e-Book
  • Anybody who is interested in standardizing practice and improving productivity / quality
  • Manufacturing & Production Personnel / Managers
  • Research and Development Personnel (R&D) / Managers
  • Quality Assurance & Quality Control Personnel / Managers
  • Regulatory affairs personnel / managers
  • Laboratory Personnel / Managers
  • Validation Specialists
  • Clinical trial personnel
  • Project Managers
  • Technical / medical writers
  • SOP users
  • ID:                                    1351
  • SKU:                                EB-0001-MQ
  • Type:                               e-Book
  • Format:                          Downloadable PDF File & (.pdf)
  • Date of Last Update:   Aug 06, 2018
  • Length:                           27 Pages
  • Course Level:                Moderate/Advance
  • Price:                              $50.00
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