Dublin, July 25, 2023 (GLOBE NEWSWIRE) -- The "Writing Standard Operating Procedures (SOP) for FDA-Regulated Industry" training has been added to ResearchAndMarkets.com's offering.
This 12-hour accredited training course titled "Writing Standard Operating Procedures (SOP) for FDA-Regulated Industry," aims to provide practical guidance on creating and enforcing effective SOPs in regulated industries. Poorly written SOPs are a common cause of deficiencies and observations cited by the FDA in 483s and warning letters, making it crucial for companies to know how to organize and deliver information for the intended audience and purpose.
Key Topics Covered:
- Purpose of Standard Operating Procedures: Understand the mandates for SOP documentation set forth by regulators like the FDA and ISO.
- How to Develop/Write Effective Written Correspondence: Learn to use specific words when writing instructions and tailor the writing to the audience.
- Understand the Innate Structures of English Grammar: Develop grammatically sound passages and choose the appropriate voice (active or passive) for different types of writing.
- Team Writing SOPs: Explore the advantages of team writing, creating buy-in, and training the trainer.
- SOP Writing for Participants: Participants will be given a topic and asked to write a short SOP, followed by discussions on their approach.
- Reviewing and Revising SOPs: Understand the importance of reviewing and revising SOPs for accuracy and clarity.
- SOP Distribution: Learn about routing SOPs for approval, the role of document control, training, and effective dates.
- Enforcing SOPs: Understand the roles of management, quality assurance, and personnel in enforcing SOPs.
- Good Documentation Practices: Explore general requirements and basics of GDP, record control, modifying records compliantly, and examples of documentation errors.
The course will be especially beneficial to quality managers, engineers, and auditors; quality assurance and control professionals; process and production supervisors; and validation engineers. There are no prerequisites for attending, but a basic knowledge of good manufacturing practices is helpful.
Speaker:
The course will be led by Kelly Thomas, Vice President at Stallergenes Greer, with over two decades of cGMP hands-on industry experience in pharmaceutical and medical device manufacturing operations. Her expertise covers all Quality Systems and areas of validation, including process/product validation, facilities validation, CSV, and 21 CFR Part 11 compliance. She has demonstrated success in managing complex projects within the pharmaceutical and medical device industries, utilizing strategic thinking, risk-based approaches, and Lean principles.
In conclusion, the "Writing Standard Operating Procedures (SOP) for FDA-Regulated Industry" training provides valuable insights and practical guidance for creating and enforcing effective SOPs in compliance with regulatory requirements. Participants will gain the knowledge and skills needed to write clear, concise, and accurate SOPs, contributing to improved compliance and streamlined operations in regulated industries.
For more information about this training visit https://www.researchandmarkets.com/r/binh9o
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