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Writing and Enforcing SOPs: Best Practices for Regulated Industries

  January 31, 2019  
CfPA-The Center for Professional Advancement, New Brunswick, NJ or Virtually
August 1-2, 2019

Who Should Attend?
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. There are no prerequisites for attending, but a basic knowledge of good manufacturing practices is helpful.

The course will be especially beneficial to:
  • Quality managers, engineers and auditors
  • Quality Assurance and Control professionals
  • Process and production supervisors
  • Validation engineers

Course Description
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. 

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 2 day accredited course 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 for 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.
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
   Joy McElroy, Consultant to the pharmaceutical and biotech industries

ith 10 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies. Ms. McElroy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing. In 2013 Ms. McElroy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients worldwide.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: Jmorbit@cfpa.com
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