4-Hour Virtual Seminar on Bulletproof SOPs: Writing Effective Standard Operating Procedures and Work Instructions

Poorly Written SOPs are One of The Most common Causes Cited in 483s and Warning Letters from The FDA!

Instructor :
Charles H. Paul

Webinar ID:
3204

Date: MAR 25, 2025 (TUE)

Start Time: 9 AM - 1:00 PM PT

Duration: 4 Hrs.

What you will learn

  • The True Purpose and Function of Regulatory Documentation.
  • What is The Value Add? What to Include in Your SOP?
  • The Key Pitfalls Associated with Writing Regulated Documentation.
  • The Documentation Hierarchy- Understand The Difference
  • The True Purpose and Function of Regulatory Documentation.
  • What is The Value Add? What to Include in Your SOP?
  • The Key Pitfalls Associated with Writing Regulated Documentation.
  • The Documentation Hierarchy- Understand The Difference
  • Documentation Formats – Key Structural Approaches
  • Gathering The Technical Information You Need.
  • How do You Write A SOP – Documentation Writing Tips

Course Description

The FDA and other regulatory bodies such as ISO (International Standards Organization) require companies to write and follow SOPs. The purpose of SOPs is to detail the regulated recurring work processes that are conducted or followed within a company.

Standard Operating Procedures – the documentation required by regulation – is essential to the effective and compliant running of any regulated business.

Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide.

Regulated documentation can serve a variety of purposes other than meeting a regulatory requirement – as training materials, to standardize operations, to manage individual and group performance, to identify the sources of deviations, etc.

The key is to knowing how to write those documents to properly meet those needs.

Join Charles H. Paul, a regulatory consultant for over 25 years, in this 4-hour interactive virtual seminar to learn how you can write SOPs that clearly communicate the processes of your business to standardize operations and ensure profitability, quality, and efficiency.

Join Now!

The FDA and other regulatory bodies such as ISO (International Standards Organization) require companies to write and follow SOPs. The purpose of SOPs is to detail the regulated recurring work processes that are conducted or followed within a company.

Standard Operating Procedures – the documentation required by regulation – is essential to the effective and compliant running of any regulated business.

Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide.

Regulated documentation can serve a variety of purposes other than meeting a regulatory requirement – as training materials, to standardize operations, to manage individual and group performance, to identify the sources of deviations, etc.

The key is to knowing how to write those documents to properly meet those needs.

Join Charles H. Paul, a regulatory consultant for over 25 years, in this 4-hour interactive virtual seminar to learn how you can write SOPs that clearly communicate the processes of your business to standardize operations and ensure profitability, quality, and efficiency.

Join Now!

Why you should attend

Written documents must be clear so that all intended readers understand how to perform their job functions effectively and safely. Failing to do so can cause compliance and quality issues!

A well-prepared SOPs can save an organization from FDA warnings and Form 483 sanctions!

Writing effective Standard Operating Procedures and Work Instructions is not intuitive, it is not a skill that is often taught in our universities, and it can be a difficult and cumbersome task to execute.

Knowing the most effective and efficient processes for gathering, organizing, and writing technical documentation is absolutely critical to providing significant value to a dreaded, avoided, and seemingly unimportant work task.

At the completion of this webinar, participants will be able to:

  • Discuss the importance of regulatory documentation.
  • Discuss the value add applications of documentation to training, human performance, and the regulatory function
  • Explain and discuss what is wrong with documentation in our organizations.
  • Define the importance of establishing a documentation hierarchy
  • How to build effective documentation templates.
  • Explain how best to gather data for your documentation.

Join Now!

Written documents must be clear so that all intended readers understand how to perform their job functions effectively and safely. Failing to do so can cause compliance and quality issues!

A well-prepared SOPs can save an organization from FDA warnings and Form 483 sanctions!

Writing effective Standard Operating Procedures and Work Instructions is not intuitive, it is not a skill that is often taught in our universities, and it can be a difficult and cumbersome task to execute.

Knowing the most effective and efficient processes for gathering, organizing, and writing technical documentation is absolutely critical to providing significant value to a dreaded, avoided, and seemingly unimportant work task.

At the completion of this webinar, participants will be able to:

  • Discuss the importance of regulatory documentation.
  • Discuss the value add applications of documentation to training, human performance, and the regulatory function
  • Explain and discuss what is wrong with documentation in our organizations.
  • Define the importance of establishing a documentation hierarchy
  • How to build effective documentation templates.
  • Explain how best to gather data for your documentation.

Join Now!

Areas Covered

  • The True Purpose and Function of Regulatory Documentation.
  • What is The Value Add – Training Vs Human Performance Vs Regulatory Compliance
  • What to Include in Your SOP?
  • The Key Pitfalls Associated with Writing Regulated Documentation.
  • The Documentation Hierarchy- Understand The Difference
  • Documentation Formats – Key Structural Approaches
  • Gathering The Technical Information You Need.
  • Using Subject Matter Experts.
  • How do You Write A SOP – Documentation Writing Tips.
  • Managing Technical Document Reviews.
  • The True Purpose and Function of Regulatory Documentation.
  • What is The Value Add – Training Vs Human Performance Vs Regulatory Compliance
  • What to Include in Your SOP?
  • The Key Pitfalls Associated with Writing Regulated Documentation.
  • The Documentation Hierarchy- Understand The Difference
  • Documentation Formats – Key Structural Approaches
  • Gathering The Technical Information You Need.
  • Using Subject Matter Experts.
  • How do You Write A SOP – Documentation Writing Tips.
  • Managing Technical Document Reviews.

Who is this course for

  • Quality
  • Production
  • Compliance
  • Engineering
  • R & D
  • Management
  • Essentially everyone in the organization that is tasked with creating regulatory documentation.
  • Quality
  • Production
  • Compliance
  • Engineering
  • R & D
  • Management
  • Essentially everyone in the organization that is tasked with creating regulatory documentation.

Instructor Profile

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant to the life sciences industry for over 25 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex human performance and compliance-related problems.

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant to the life sciences industry for over 25 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex human performance and compliance-related problems.

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