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

Keith-Gibbs
Speaker: Keith Gibbs
Owner of Ninja Project Management
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Date: March 29th Wednesday
Time: 01:00 PM EDT | 10:00 AM PDT
Duration: 90 Minutes
Product Code: 300238
Level: Intermediate
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 
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.

As the owner of Ninja Project Management, Mr. Gibbs relies on his eighteen years of experience in Project Management, Engineering, Construction Management, Commissioning & Qualification (Verification), Validation, Quality Assurance, and Pre-Operations Management Support for the pharmaceutical, biotechnology, semiconductor and utility generation and transmission industries, to help clients succeed. Typically, responsible for the management of cGMP or specialty projects that involve start-up, commissioning, qualification and validation, he is best utilized for short-term, fast track, complex projects. His greatest strength is applying his expertise to projects that need to be brought back on track, and he is a recognized leader for project salvage and restoration planning. To support these tasks, he is involved in the preliminary design review, constructability review and master planning activities to ensure the integration of all phases of a project in the support of turnover, start-up, Quality Assurance and Validation requirements. 

In his career, he has managed the design, installation, start-up and qualification of utility, facility, control and process systems for laboratories and pharmaceutical manufacturing facilities. A leader in the integrated approach to commissioning and qualification, he has extensive experience in authoring and executing test plans and protocols. A unique specialty is the development of leveraged Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) plans as part of integrated Commissioning/Validation efforts. Another hard earned specialty is the extensive experience in deviation resolution.

Mr. Gibbs has managed teams from 2 to 40 direct reports on projects from $50,000 to $50,000,000. He has supported innovative projects with full life-cycle involvement, as well as task focused short cycle assignments.

In his free time, he runs a small business, Raleigh Llama Salvage and Restoration, where he seeks out and restores items and artefacts of interest to him. He is an avid disc golfer and enjoys time with his family.

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