Standard Operating Procedure e-Book (Step-by-Step Guide)
Description
Author’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.
Overview
This Standard Operating Procedure e-Book provides an overview of SOP and a step-by-step guide. It enables you to design your own SOPs. Also, we have included a sample of an SOP to show you all the items you should include in one. Generally, 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.
This comprehensive guide (Standard Operating Procedure e-Book) will teach you how to produce an effective SOP. Furthermore, we have included an MS Word template you can use as a starting point for preparing a standard SOP. Also, we have included a proposed structure for an SOP, draft language, and other guidance to assist you in creating a good SOP. As well, 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
- Notice the importance of SOPs to your specific work environment (explaining the top ten reasons for warning letters from regulatory bodies, three of which are SOP-related)
- Understand their benefits and limitations
- Comprehend 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 within [ ] indicates a placeholder where you can insert specific detail (replace as appropriate).
- Ensure that you replace all placeholders and example text with the function-specific information.
- In the template, the instructions and explanatory text are indicated by <blue italics>, which you can use 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.
- You must use the logo of the Institution on this form.
- Leave the template version information in the document
Who Can Benefit From This Standard Operating Procedure e-Book
- Anybody 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
Details
- 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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