Strategic Approaches in Integrating Risk and Quality Management in Life Sciences
In today’s highly-regulated environment, life sciences and pharmaceutical quality activities are often associated with maintaining regulatory compliance. However, both regulators and quality professionals are beginning to understand that compliance alone will not ensure high product quality and patient safety. In light of increasing competition, drastic changes and regulatory uncertainties, life sciences organizations need to enforce new concepts in management that will support the evolving business environment in which they operate. In the life sciences industry, integrating risk and quality management is becoming the new standard for measuring and monitoring quality and compliance activities. The benefits in successfully aligning these two fields can optimize resources to effectively achieve quality goals and find an optimal balance between operational costs and common risks.
In this light, a panel of key thought leaders and practitioners assembled by The Knowledge Group will provide an in-depth discussion on the significant issues and latest insights involving the role of risk and compliance in quality management, outline some of the benefits of risk-based methods and will also offer best practices in developing and implementing strategic approaches for managing risk and compliance that will help organization better evaluate risks and find a way to streamline an adaptive quality management strategy.
Some of the major topics that will be covered in this course are:
- Risk Management and Quality Management – Overview
- Common Ground Between Risk and Quality Management
- Risk Management in Life Sciences and Pharmaceutical Industry
- Quality Management in Life Sciences and Pharmaceutical Industry
- Risk and Quality Management Integration
- Strategic Approaches to Risk and Quality Management Integration
Florian Czaszewicz, Industry Solutions Consultant
Pilgrim Quality Solutions
- Defining Quality Risk Management: From Outer Space to Inner Complexity
- Getting Started on the Path to Risk-based Quality Management
- Managing the Flow of Risk-based Quality System Activity
- Recommendations for Strengthening Risk-based Processes
Lee Young, Director Supplier Quality, Life Science Solutions
Thermo Fisher Scientific
- Making risk into an uncertainty advantage. Get away from building inventory and FMEA based thoughts.
- Risk management, where does it belong? Quality or Procurement?
- Taking your risk management group to the next level, the cloud.
Dr. Carmine Jabri, President/CEO
E.M.M.A. International Consulting Group, Inc.
- Comparing Quality Management Systems (QMS) in the Medical Device & Pharmaceuticals industries
- Should QMS be designed for compliance purposes only? Compliance/operational excellence?
- Strategic approaches to integrating QMS in the Medical Device & Pharmaceuticals industries
Who Should Attend:
- Quality Assurance Professionals
- Quality Engineers
- Quality Control Managers
- Directors of Quality
- Chief of Quality Management
- VP of Quality
- Regulatory Affairs Specialists
- Regulatory Associate/Coordinator
- Vice President/Head of Regulatory Assurance
- Drug Manufacturing Executives
- Pharmaceutical Companies
Florian Czaszewicz has worked within the Life Sciences industry and technology environments for almost two decades. He has held regional responsibilities for the Biomedical Operations and Regulatory Affairs IT department at Genzyme (a Sanofi Company), as well as the Global Regulatory Sciences Informatics division at Bristol-Myers Squibb.
From business analysis, global SDLC projects, and GXP Compliance Audits, to post-delivery activities, Florian has designed and introduced new systems, and set up collaborative platforms for R&D organizations. In his tenure as Account Manager, Florian has been accountable for the commercial success of global eClinical organizations prior joining Pilgrim Quality Solutions as Industry Solutions Consultant.
Florian Czaszewicz has worked within the Life Sciences industry and technology environments for almost two decades. He has held regional …
Lee Young has worked at various companies for 27 years in supplier management, including Intel Corporation, L-3 Communications, Carefusion and currently works in supplier management at Thermo Fisher Scientific. Lee holds an engineering degree in Chemical Engineering from the University of Arizona, a masters in engineering from Arizona State University and currently sits on the advisory board for the engineering department at the University of San Diego. Lee is also a founding member of the Global Resiliency Council in San Jose, California.
Lee Young has worked at various companies for 27 years in supplier management, including Intel Corporation, L-3 Communications, Carefusion and …
As co-founder of E.M.M.A. International Consulting Group, Inc., Carmine Jabri, PhD, MSJ, MSQM, MHA serves as E.M.M.A. International’s President and CEO. Dr. Jabri is an experienced Healthcare and Quality Assurance professional with more than twenty years of experience implementing, improving and directing Quality Management Systems and Healthcare Operations.
His career includes expertise in the Biotechnology, Pharmaceuticals, and Medical Device industries. Dr. Jabri's extensive knowledge of regulations and guidelines, coupled with his training and facilitation skills, help him lead the team of E.M.M.A. International consultants to help organizations improve their quality management systems, reduce costs, reduce errors, and comply with federal, state, and international standards and regulations. Dr. Jabri is an internationally sought after quality systems expert.
Dr. Jabri holds a Doctor of Philosophy in Epidemiology, a Master of Science in Jurisprudence, a Master of Science in Quality Management, a Master of Science in Health Services Administration and a Bachelor of Science in Chemistry.
As co-founder of E.M.M.A. International Consulting Group, Inc., Carmine Jabri, PhD, MSJ, MSQM, MHA serves as E.M.M.A. International’s President and …
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Method of Presentation:
Experience in pharmaceutical law
NASBA Field of Study:
Management Services - Technical
NY Category of CLE Credit:
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About Pilgrim Quality Solutions
Pilgrim Quality Solutions is the leader in quality compliance management software and services for Life Sciences. For more than 20 years, our solutions have automated thousands of processes across global company sites to manage the quality and compliance of life’s most important products. Our cloud-based and on-premise solutions include in-the-box best practice workflows, document and process management, dashboards, electronic signatures, audit trails, and automated validation – helping companies more easily achieve quality system compliance and pass regulatory audits. Pilgrim Quality Solutions is majority owned by Boston-based private equity firm, Riverside Partners LLC. With Pilgrim Quality Solutions as your partner, you are prepared to succeed. For more information, visit www.pilgrimquality.com.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $18 billion and more than 55,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support
About E.M.M.A. International Consulting Group, Inc.
E.M.M.A. International Consulting Group, Inc. is a global leader in management consulting services, with headquarters in Farmington Hills, MI. They focus on quality, regulatory, and compliance services for the Biotechnology, Pharmaceuticals, Medical Device and all other FDA regulated industries.
Think of E.M.M.A. International Consulting Group as a ‘one stop shop’ for all of your quality and compliance needs. They provide a wide array of specialized services to their clients, backed by extensive knowledge and industry experience. E.M.M.A. International Consultants are innovative and focused on addressing clients’ needs. E.M.M.A. International’s mission is to provide significant value to clients’ operations and leave their customers completely satisfied that their expectations were fulfilled. E.M.M.A. International works within the corporate culture and alongside the employees to do the “heavy lifting” required to make improvements meaningful and permanent.