Today’s modern regulated business, i.e. pharmaceuticals, medical devices, biotechnology, etc., is in a unique position, because of regulation, to install the tools and techniques that are essential to lean, effective operations.  The problem is, many of those businesses simply don’t “get it.”  They discount the human factor – the human element – as an ingredient of success and fail to make the needed investment in their human capital that will directly yield significant benefit in both the measurable and regulated aspects of their business.  They discount and de-value standardization, continuous improvement, training, and effective management as pillars of success and overlook the incredible value that human performance brings to the organization.

Those businesses that do “get it,” are successful, innovative, compliant, and profitable.

This seminar will explore the unique and critical relationship between regulatory compliance, compliance documentation, and technical operations training and improved performance, standardization, and world-class regulatory compliance.

We will also discuss 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.

Areas Covered in the Session:-

Session 1:  Introduction to Documentation, Training, and Compliance

• What are SOPs and Work Instructions and why are they important?
• The relationship between compliance documentation and training
• Elements of a compliant documentation and training system
• Global regulatory requirements for compliance documentation and training
• What are common practices - effective and ineffective
• What are user support tools and why are they important?
• What are the risks of ineffective execution?

Session 2:  Determining the Gaps – What do you need to develop to meet all of your training and regulatory requirements

• What gets documented?
• How regulatory documentation and training are linked
• Regulatory compliance documentation hierarchies
• Read and understand versus demonstrated competence
• The gap analysis - Areas of the organization/process that must be examined and analyzed
• Conducting the gap analysis – using subject matter experts
• Training task characteristics that impact training delivery
• Use of the Analysis Tool to determining your Gaps

Session 3:  Building SOPs and Work Instructions

• The pitfalls associated with writing regulated documentation.
• The documentation hierarchy.
• Documentation formats.
• Gathering the technical information you need.
• Using Subject Matter Experts
• Using photography effectively
• Documentation writing tips.
• Managing technical document reviews
• Writing effective compliance documentation

Session 4:  Using Standard Operating Procedures and Work Instructions to Meet Regulatory Requirements,  Standardize Operations, Manage Performance, and Support Training

• Standardization defined
• Applying standardization to all facets of product manufacturing
• The standardization process – facilitating standardized operations
• Managing performance to standardized tasks

Session 5:  Human Performance and How it Fits

• The relationship between human behavior and organizational performance.
• The cost of human capital – what it costs you and what it can yield.
• Making human behavior real – let’s look at real examples
• The 6-Cell Performance Engineering Model
• Implementing the model in your organization

Session 6:  Building and Executing Training in the Life Sciences

• Define training in the context of compliance and regulated manufacturing
• Define training’s impact upon human performance
• Tools, Guides, Standards, and conditions
• Performance objectives, how they are developed, and how they impact the training process
• Explain the types of training applications that are appropriate in given circumstances
• Define the training development process
• Training beyond GMPs
• 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

Background:-

There is an increasing trend for regulatory agencies to view compliance documentation and training and its direct relationship to operations and human performance with increased scrutiny.  Documentation and training that is improperly developed, implemented, and/or recorded present a significant regulatory risk for manufacturers.  In addition to meeting regulatory requirements, documentation, and training that is properly developed, also can serve as the basis for a well-controlled operation and a highly-competent workforce.  Competence and standardization impacts compliance.

This seminar will describe the environment in which success can be fostered with the tools that you already have at your fingertips – compliance documentation, training, and a management organization that believes.  An effective model of human performance will be described and discussed in terms of its relationship to those tools and how they are essential to the execution of the goals and objectives of the business.  In addition, the techniques for implementing that model will be presented that will have a direct impact on organizational performance.

This seminar will provide the knowledge and skill needed to shape and structure the organization for success from top to bottom and from the bottom to the top all within the regulated environment.  Human performance can be engineered and if done properly, can effectively yield benefits that far outweigh the investments made.  Using those tools that you have at your fingertips.

Level:-

Basic & Intermediate

Why should you attend:-

If you want to reduce equipment downtime – if you want to significantly reduce your regulatory risk - if you want to virtually eliminate the losses that result from poor performance – if you want to increase utilization – and if you want to demonstrate world-class operational and regulatory performance, this seminar will provide the keys to that level of success.  And if I might add, you can do those things with a minimum of investment by leveraging those aspects of the organization that are already available to you and that you should be doing anyway.  The difference is, we will provide you with the guidance, the tools, and techniques to make this happen.

We will present, at the completion of the seminar, to tie all of the pieces together, a case study of a Fortune 100 pharmaceutical organization that actually realized those benefits bringing significant benefit to the organization’s bottom line.  Yes, this process as we will describe it can pay for itself.

Who will benefit:-

Personnel in any life sciences organization will benefit from this virtual seminar.

All levels of management across all functional areas to include human resources, training, and regulatory compliance.  Operations personnel will significantly benefit from this training as will training, documentation, and regulatory compliance personnel.

Positions include Directors, Managers, Supervisors, and Associates.

Target Companies:-

Pharmaceuticals, Medical Devices, Biotech, API Manufacturers, Chemicals, Foods, Beverages, Cosmetics, etc.

Target Association/Societies:-

• 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
• National Food Processors Association of NFPA
• US Food Processors Association

Target  Audience to market:-

Directors, Managers, supervisors, team leaders, project managers – anyone having responsibility for the performance of others, operational performance, and regulatory compliance.