3 Day Writing and Enforcing SOPs for FDA-Regulated Industry Course: Best Practices to Withstand FDA Expectations

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Apr 03, 2023, 19:45 ET

DUBLIN, April 3, 2023 /PRNewswire/ -- The "Writing and Enforcing SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations Course" training has been added to ResearchAndMarkets.com's offering.

This course is intended for all personnel directly involved in the development of standard operating procedures including those responsible for writing validation protocols or execution activities. Beginning or seasoned operational personnel who will participate in team writing and individuals in management who communicate with regulatory agency inspectors will also benefit from attending this course.

Writing and enforcing effective standard operating procedures (SOPs) can be challenging. Poorly written SOPs are one of the most common causes of deficiencies and observations cited in 483s and warning letters from the FDA. Companies in regulated industries must know how to organize and deliver information for the intended audience and the intended purpose. This course will address how to write effective Standard Operating Procedures and Work Instructions in support of company activities. Participants will learn how to organize and deliver information for the intended audience and purpose. They will learn how to write clear and readable documents, and how to revise and refine their own and others' writing. This 12-hour accredited training will cover practical guidance on the purpose of Standard Operating Procedures as well as the requirements from regulators for SOPs. Guidance will be provided on how to write from the reader's perspective, and how to structure SOPs so that they are accurate, concise, and to the point.

Tips on formatting SOPs will be given. Examples of current FDA finding for SOP deficiencies will be given and discussed. Practical and effective SOPs templates will be shared with the participants. This course will provide guidance for team writing of SOPs, as well as best practices for SOP distribution. Good documentation practices will also be discussed

The course will be especially beneficial to:

Quality managers, engineers and auditors
Quality Assurance and Control professionals
Process and production supervisors
Validation engineers

Agenda

Review of Learning Objectives

Purpose of Standard Operating Procedures

Mandates for SOP documentation set forth by the regulators, such as the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and other governing bodies

How to Develop/Write effective written correspondence

Use of specific words when writing instruction

How to write to the audience

Know how to organize and deliver information based on the message
Understand how to structure SOPs

Understand the innate structures of English grammar

How to create grammatically sound passages
How the active and passive voices work and how to choose the most appropriate one for the type of writing you are doing

Team writing SOPs

Advantages
Creating buy in
Training the Trainer

SOP writing for Participants

Participants will be given a topic and asked to write a short SOP, they will have time to discuss how they would approach the writing with a team.

Reviewing and Revising SOPs

Final Questions/Comments/ Discussion

Understanding writing Patterns

Knowing the answers to questions about the English language

Confidence in writing and revising SOPs

Practice writing and revising

SOP Distribution

Routing SOPs for approval
Role of document control
Training
Effective dates

Enforcing SOPs

Management's role
Quality Assurance's role
Personnel's role

Good Documentation Practices

General requirements
GDP basics
Record control
Modifying records in a compliant manner
Attachments and printouts
Examples of documentation errors with attendee participation

Final questions/Answers/Comments

Assessment Opportunity

Speakers:

Kelly Thomas
Vice President
Stallergenes Greer

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

For more information about this training visit https://www.researchandmarkets.com/r/uykozx

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SOURCE Research and Markets