Duration: 3 Hour


Purchase Options: *

Learn More

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.

This seminar will also explore the area of training in regulated environments, its importance, and its relationship to compliance documentation. Training is one of the most underrated and least respected of all the disciplines found within modern manufacturing within regulated industries – foods, cosmetics, beverages, medical devices, pharmaceuticals, biologics, etc. Yet, training is equally as important as any compliance discipline.

The major problem today is how training is applied, how training is administered, and how training is managed within the modern regulated industry. We will look at Best-in-Class applications of training and how training can significantly contribute to not only world-class compliance but improved operational performance, improved quality, and improved employee/associate safety. And how together, effective documentation and training can significantly improve your operations.

Topic Background:

Training and documentation within the Life Sciences are inextricably linked together into an integrated system that combines “Best Practices,” regulatory compliance, principles of human performance, and adult learning to achieve the most favorable outcome of superior worker performance and the achievement of compliance excellence.

Training is the process by which individuals acquire skill and knowledge. There are a variety of approaches and techniques that should be applied to specific situations to achieve maximum effectiveness. Uninitiated training personnel often apply training techniques that are totally inappropriate for the situations for which they are utilized resulting in very ineffective training. Read and Understand is a technique that is and has been extremely abused in the training field within regulated industries for many years because it is cheap and requires the minimum expenditure of the organization’s resources. The problem with this approach is that it is totally inappropriate for the majority of situations in which it is applied. From a regulatory standpoint this is extremely important to know because ineffective training within regulated industries equals a potential for compliance deficiencies.

Regulatory compliance documentation on the other hand, is the process by which key critical tasks are or should be documented within our Life Sciences businesses. What is Regulatory Documentation and what role does it play in this process?

Compliance documentation to include 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. In addition, the significant relationship between compliance documentation and training has not escaped regulatory scrutiny. When regulators look at documentation they also look at training in terms of the individuals to which the documentation applies and vice versa.

Areas Covered in the Session : 


Session 1:

Achieving Excellence through Training & Documentation


  • The relationship between human behavior and organizational performance
  • How training, documentation, and management action impact operational excellence – elements of compliance excellence
  • The cost of human capital – what it costs and what it can yield
  • Making it all real – let’s look at a case study
  • Implementing the model in your organization

Session 2:

Regulatory Documentation – The Foundation


  • The true purpose and function of regulatory documentation
  • What is the value add?
  • The pitfalls associated with writing regulated documentation
  • The documentation hierarchy
  • Documentation formats
  • Gathering the technical information you need
  • Using Subject Matter Experts
  • Documentation writing tips
  • Managing technical document reviews

Session 3:

Training & Development – the Implementation Method


  • Define training in the context of compliance and regulated manufacturing
  • Define training’s impact upon human performance
  • Explain the types of training applications that are appropriate in given circumstances
  • Discuss how a training needs analysis is conducted as specified by regulation
  • Define the training development process
  • Training beyond GMPs
  • Explain the relationship between technical training and compliance documentation
  • Discuss the training pitfalls and misapplications of training and their impact upon regulatory compliance
  • Discuss the dangers in relying upon “Read and Understand”
  • Explain how training should be managed in the modern regulated industry

Session 4:

Putting it all Together


  • Building an effective training function
  • Training trainers
  • Executing effective training
  • Testing to assure competence

Who Should Attend:

Members of: 

  • American Society for Quality
  • American Pharmaceutical Manufacturers of America
  • Generic Drug Manufacturers Association
  • National Pharmaceutical Association
  • International Society for Pharmaceutical Engineering
  • Medical Device Manufacturers Association
  • European Medical Device Technology
  • Gulf Coast Medical Device Manufacturers
  • American Society for Training and Development (ASTD)
  • Training and Development Departments
  • Operations Departments
  • Documentation Departments
  • Manufacturing Departments
  • Quality Departments
  • Production Departments
  • Regulatory Departments
  • Compliance Departments
  • Technical Services
  • Human Resources Departments
  • Research and Development Departments
  • GxP Professionals
  • Consultants
  • Small business owners

Course Director: CHARLES H. PAUL

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product – OTC industries.