6-HR Virtual Seminar - SOP's and Work Instructions, Training, and Compliance in the Life Sciences

Why Should You Attend:

This webinar will help you reduce downtime, significantly reduce compliance risk, reduce the loss caused by poor performance, increase utilization, and showcase best-in-class operational and regulatory performance. You will be provided with the guidance, tools, and techniques to this come to reality.

Regulated businesses such as those in the pharmaceuticals, medical devices, and biotechnology are in a unique position to implement tools and techniques that are critical to lean, effective operations. The reality is, many of those businesses just do not understand it. Not realizing that the human element – the human factor can directly produce significant benefit in both the quantifiable and regulated aspects of their business, they fail to invest in human capital. They cut corners and de-value standardization, continuous improvement, training, and effective management as pillars of success and don’t give importance to the incredible value human performance brings to their business.

Those businesses that understand are successful, innovative, compliant, and profitable. In this seminar, you will learn how regulatory compliance, compliance documentation, and technical operations training and improved performance, standardization and world-class regulatory compliance are uniquely interwoven.

You will also learn the importance of the field of training, and its relationship with compliance documentation. Although training is as important as compliance discipline, it is the most overlooked of all the disciplines within modern manufacturing industries such as foods, cosmetics, beverages, medical devices, pharmaceuticals, biologics, and more. This seminar will explore how training can significantly contribute to world-class compliance, operational performance, improved quality, and personnel safety.

Areas Covered in the Webinar:

• 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

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