Whitepaper
The Crucial Role of Quality Management Systems
February 02, 2024 Steve Masi, Jeffrey Silverman, Eliza Deriso
The rapidly evolving landscape of the medical device, biologics, and biotechnology industries is not only expanding quickly but also becoming increasingly more complex and regulated. The excitement of bringing a new concept to life often overshadows the intricate and critical processes required to establish a successful company in these fields. The true foundation for any company seeking to secure a place in the commercial market is undeniably built on a bedrock of quality. In this whitepaper you’ll get answers to the following questions:
- Why is Quality Integral?
- What is the measurable impact of quality on your organization?
- What are the main objectives of a foundational quality system, and how can they benefit your operation in the long term?
Steve Masi
Steve Masi is a senior consultant for Azzur Group. He has nearly 30 years of experience in design, development, manufacturing, quality of implantable and nonimplantable medical devices in a regulated cGMP environment. He also has experience working in the pharmaceutical industry and has a working knowledge with the associated ICH and FDA regulations.
Since 2005, Steve’s area of expertise has been primarily rooted in the medical device field in R&D, manufacturing, and quality. He has worked with products such as brain and spinal implants used in drug delivery, diffusive membranes, colonoscopy products, voice prostheses and accessories, breast implants, wound adhesion products, proton therapy systems, and electroporation systems for drug delivery. He has also worked on quality teams in support of critical utilities supporting medical device and pharmaceutical manufacturing operations. At Azzur Group, his current role includes work on the creation, implementation, maintenance/support, and gap assessments of phase-appropriate quality systems, as well as quality support f
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Since 2005, Steve’s area of expertise has been primarily rooted in the medical device field in R&D, manufacturing, and quality. He has worked with products such as brain and spinal implants used in drug delivery, diffusive membranes, colonoscopy products, voice prostheses and accessories, breast implants, wound adhesion products, proton therapy systems, and electroporation systems for drug delivery. He has also worked on quality teams in support of critical utilities supporting medical device and pharmaceutical manufacturing operations. At Azzur Group, his current role includes work on the creation, implementation, maintenance/support, and gap assessments of phase-appropriate quality systems, as well as quality support f
Jeffrey Silverman
Jeffrey Silverman is the Vice President of Product Engineering and Manufacturing for OncoSec. As an engineering management veteran, Jeff brings to OncoSec extensive global industry experience in the development, manufacturing, and scale up of medical devices including electroporation and gene delivery equipment for the delivery of DNA drugs in support of cancer and vaccine research.
For more than five years, Mr. Silverman served as Vice President at Ichor Medical Systems, Inc., an industry leader focused on the development, manufacture, and sale of electroporation devices for the intracellular delivery of nucleic acid-based drugs encoding therapeutic proteins. While at Ichor, he was responsible for establishing and leading the engineering, operations, and quality teams for the company’s electroporation equipment for the delivery of DNA drugs in support of cancer and vaccine research. Mr. Silverman was also responsible for engineering design execution and planning, supply chain, supplier audits, internal, and external manufacturing and contract coordination.
Prior to joining Ichor Medical Systems, Mr. Silverman was the Managing Director at Varioscale, Inc. Adding to his past experience, he held a variety of engineering and business manager roles, including his time at Abbott Laboratories and Guidant Corporation where he managed business alliance, program management, engineering/manufacturing process development, and improvements.
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For more than five years, Mr. Silverman served as Vice President at Ichor Medical Systems, Inc., an industry leader focused on the development, manufacture, and sale of electroporation devices for the intracellular delivery of nucleic acid-based drugs encoding therapeutic proteins. While at Ichor, he was responsible for establishing and leading the engineering, operations, and quality teams for the company’s electroporation equipment for the delivery of DNA drugs in support of cancer and vaccine research. Mr. Silverman was also responsible for engineering design execution and planning, supply chain, supplier audits, internal, and external manufacturing and contract coordination.
Prior to joining Ichor Medical Systems, Mr. Silverman was the Managing Director at Varioscale, Inc. Adding to his past experience, he held a variety of engineering and business manager roles, including his time at Abbott Laboratories and Guidant Corporation where he managed business alliance, program management, engineering/manufacturing process development, and improvements.
Eliza Deriso
Eliza Deriso is a seasoned professional with a strong background in quality management and auditing. With a career spanning over a decade in both the automotive and life science industries, Eliza has amassed extensive experience in driving quality initiatives. Following a transition from the automotive sector to the life science industry, Eliza joined Azzur Group in 2021, and now leads an audit program that encompasses GMP, GLP, GCP, Medical Device, and Mock FDA audits, among others.
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