WEBINAR: Simplifying Quality Systems for Tissue Engineering Success: Lessons from the Nuclear Power Industry

Simplifying Quality Systems for Tissue Engineering Success: Lessons from the Nuclear Power Industry
Wednesday, September 25, 2019
12:00 PM Eastern Daylight Time
 

View on Demand

Summary:
In the tissue engineering industry there is a lot of discussion around the complexities of seeding adherent cells, the best modes for generating vascularized scaffolds, the challenges associated with the packaging and transport of tissue-engineered medical products (TEMPs), and how to get your product to market quickly.

This webinar will provide an overview of quality systems for individuals in the tissue engineering and/or regenerative medicine industries who want to better support their company’s performance and compliance. Over the course of an hour, this webinar will also include:

• Facts about the value and importance of quality systems prior to the scale-up process
• Basic tenants of these systems throughout an organization including policies, procedures and procurement
• Basic elements of a quality systems manual
• Brief case studies focused on nuclear raw materials and a TEMP product to demonstrate the depth of complexity that can be attained while providing support and guidance on how to create the quality system documents in a highly regulated industry

There is much less focus on the underlying quality management systems that enable a company to efficiently and effectively achieve a quality TEMP that meets the requirements of both the manufacturer and the end user. This has the potential to result in substantial financial and productivity impacts. Register for this webinar to learn how to achieve the highest quality TEMP from the beginning of its development and ensure future success for you organization.

View on Demand

About the Presenters:

Michael Frediani, Director, Audit & Inspections, ASME
Michael Frediani manages ASME's 85-person global auditing force. This includes their qualification, training, and scheduling of more than 1,700 surveys and audits annually for ASME’s five Conformity Assessment product programs and two Accreditation programs.

Michael has 15 years’ experience as an engineer and inspector for nuclear and non-nuclear power generation. He served six years as a nuclear reactor operator in the US Navy and six years as an in-service inspector conducting and documenting risk evaluations, inspections, surveys, and claims investigations on a wide range of power generation and manufacturing facilities for the insurance industry.

Eric Blahut, Quality System Consultant, Advanced Regenerative Manufacturing Institute (ARMI)
Eric Blahut, former Senior Director of Manufacturing at Histogenics Corporation, a late-stage regenerative medicine company that was developing a leading product, NeoCart, for articular cartilage repair, worked in the Research, Product Development and Manufacturing departments for 19 years. During that time, Mr. Blahut was integral in the development and implementation of different aspects of the Quality System for the GMP production of NeoCart. Mr. Blahut has taken part in multiple quality and process audits during due diligence activities with potential investors as well as corporate partners. He has also participated in the authoring of regulatory filings with the FDA, Health Canada and PMDA.

Mr. Blahut is currently working as a Quality System consultant to develop and implement the initial portions of the Quality System at ARMI in preparation of GMP production activities.