An Introduction to Risks associated with Extractables, Leachables & Elemental Impurities in cGMP Manufacturing: A Project Managers Perspective

Key Take Away :

This webinar will present a unique perspective on risks associated with extractables, leachables & elemental impurities (ELEI) in cGMP manufacturing of pharmaceutical, biologic and medical device products.

Overview :

This pharmaceutical risk assessment webinar for quality risk management in pharmaceutical industry will start with a definitional review of risk management in pharma and then present the current FDA perspective on 1099 risk mitigation of impurities of these types in product. After the credit risk mitigation introduction, the instructor will present quality and compliance considerations related to ELEI. 

What will make this webinar unique is the presentation of three distinct case studies related to a project manager’s perspective of ELEI. 

The first involves a large blood fractionation facility and the successful implementation of a materials management program 
The second looks at a medical device manufacturer and the struggle from changing a certain product container from glass to plastic 
The third looks at a variety of lessons learned surrounding clean compressed air delivery to manufacturing processes 
This webinar will give the attendee a strong understanding of credit risk mitigation strategies and knowledge that they can then apply, same day, to their own work.

Why Should You Attend :

This HIPAA risk analysis, risk assessment and HIPAA security risk assessment webinar is daunting to many outside of the laboratory setting. For most in the drug treatment manufacturing world, the chemistry involved/ risk based internal audit is not part of their vocabulary, nor should it be. 

An attendee of this webinar will be given a strong understanding of risk management corporate governance, but more importantly, be given the talking points to be able to add value to the conversation. 

This risk management for corporate leader’s webinar will leave attendees confident that they could support a project related to risk analysis, risk mitigation techniques or deviation resolution related to extractables, leachables & environmental impurities, with a basic understanding of the regulatory importance to cGMP manufacturing, and some memorable lessons learned that they can refer to throughout their career.

Areas Covered In This Webinar :

• Introduction of the Topic
• Introduction of the Presenter
• Safety Minute
• Definition of Extractables
• Definition of Leachables
• Definition of Environmental Impurities
• Review of Regulatory Guidance
• Risks – Quality Considerations
• Risks – Safety Considerations
• Risks – Efficacy Considerations
• Case Study – Materials Management Program
• Case Study – Product Development
• Case Study – Direct Impact Critical Utilities
• Lessons Learned
• Conclusions

Learning Objectives :

• Understand the importance of the topic
• Understand the definition of extractables, leachables & environmental impurities
• Understand the risks associated with the topic
• Takeaway lessons learned on case study projects

Who Will Benefit :

Anyone involved in the Direct Manufacturing or Manufacturing Support of Pharmaceuticals, Biologics or Medical Devices

Level: 
Intermediate

Speakers Profile :
Keith Gibbs
Mr. Gibbs is a highly motivated leader with a proven project management track record. Able to interface with and motivate people at all levels of an organization or project and across all business units, he works diligently on the application of best practices. He possesses an extensive experience organizing and supervising the business activities of project teams, within budget and to tight timetables. An innovative thought leader who is well respected by industry peers for creative and applicable solutions to complex problems, he has proven planning and brainstorming expertise that has established a framework for successful projects and business practices. 

Mr. Gibbs is a sought after trainer and educator who has a gift for motivating fellow professionals to reach their peak performance. Through many years of in the field experience, he possesses a full and applied understanding of the business of consultancy support to industry.

Others Details

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