The Life Sciences’ Supplier and Contractor Qualification and Control Framework Explored!
In today’s uptight global competition regulations, organizations in the life sciences industry need a quality management process that is critical both to quality compliance and continuous product improvement to meet the changing requirements of the consumer. However, one of the toughest challenges in quality management practices is effective supply chain control and management.
In this light, a panel of industry leaders and quality solutions provider assembled by The Knowledge Group will provide the audience with a roadmap of best practices involving supplier/contractor qualification and control. The panel will also explore key strategies in facing the challenges of Supplier and Contractor Qualification and Control, thus, helping the organizations mitigate risks and take corrective action.
The panel will also deliberate, but not limit discussion to:
- Internal Process and Quality System Audits and Assessments
- Manufacturing and Production Processes
- Supplier Quality and Purchasing Controls
- Common Regulatory Risks and Potential Pitfalls
- Practical Solutions and Best Practices
Florian Czaszewicz, Industry Solutions Consultant
Pilgrim Quality Solutions
- The Life Sciences Supplier and Contractor Landscape
- Responsibilities and Obligations
- Traditional Approach
- Reading the Signals early on
- Where it all comes together: Get in control!
Nicky Dodsworth, Quality Assurance, Risk & Compliance
- Key challenges to establishing an effective vendor management program
- Recommendations for establishing an effective vendor management program
- Vendor audits – remote versus onsite/ types of audits for vendors/ which works best?
- I can also talk on typical audit findings for vendors
Dr. Benjamin J. Del Tito, Jr., Senior Consultant
Biologics Consulting Group, Inc.
- Describe and discuss a solid Vendor/Supplier Qualification Process
- Determine level of oversight/on-site presence required
- Monitor and Re-evaluate your Vendor(s)/Supplier(s)
- Establish Secondary (Back-up) Vendor(s)/Supplier(s)
Peggy J. Berry, President and CEO
Synergy Consulting LLC
- wrap up and highlights
- associated regulatory issues
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 BMS.
From business analysis, global SDLC projects, 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 more recent tenure as a Business Development Manager, Florian has also been accountable for the commercial success of leading global eClinical organizations.
Florian currently supports Pilgrim’s European team as an industry expert who understands, demonstrates, and positions Pilgrim’s solutions, "linking" their key value to client business drivers.
Florian Czaszewicz has worked within the Life Sciences industry and technology environments for almost two decades. He has held regional responsibilities …
Nicky Dodsworth is currently Vice President, Quality Assurance, Risk & Compliance at Premier Research. Nicky is co-Chair of the GCP Forum for the Institute of Clinical Research. As an active member of the European Forum for Good Clinical Practice (EFGCP) she chairs the Education Working Party. Nicky runs the accredited EMWA Workshop on Quality Awareness in CSR Development. She has assisted in preparation of the 4th Edition of Fraud and Misconduct, Royal Society of Medicine Press, by writing the chapter on enhanced audits; she has published a chapter on Audits and Inspections and Fraud and Misconduct for the Oxford Handbook of Clinical and Healthcare Research and for the new 2017 Clinical Research Manual has written a chapter on Good Clinical Research Practice.
Nicky Dodsworth is currently Vice President, Quality Assurance, Risk & Compliance at Premier Research. Nicky is co-Chair of the GCP …
Dr. Del Tito joined Biologics Consulting, as a Senior Consultant (Quality & Regulatory Affairs) on March 2, 2015. He’s had thirty-plus years of experience in both large pharmaceutical and small to mid-sized biotechnology companies specializing in products such as protein therapeutics, vaccines and monoclonals. His career has focused on the areas of analytical development, quality control, bioanalytical assays, quality assurance, and regulatory affairs. He is knowledgeable in global drug development (Phases I-IV), IND, IMPD, NDA, and BLA submissions, regulatory interactions, and regulatory inspections for US, Canada, Latin America and Europe/UK.
Ben previously served as Executive Vice President of Regulatory Affairs and Project Management, where he oversaw both departments for Auxilium Pharmaceuticals, Inc. (now Endo Pharmaceuticals). He earned a BA in Biology from Millersville University, an MS in Biochemistry from Western Kentucky University, and a PhD in Molecular Biology from Lehigh University.
Dr. Del Tito joined Biologics Consulting, as a Senior Consultant (Quality & Regulatory Affairs) on March 2, 2015. He’s had …
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies …
Print and review course materials
Method Of Presentation:
Experience in Life Sciences Law
NASBA Field of Study:
Production - Non-Technical
NY Category of CLE Credit:
Areas of Professional Practice
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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 Premier Research
Premier Research is a leading clinical development service provider that helps highly innovative biotech, medical device,and specialty pharma companies transform breakthrough ideas into reality. The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, dermatology, medical device, neuroscience, oncology, pediatric, and rare disease. Premier Research operates in 84 countries and employs 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. They are focused on smart study design for advanced medicines that allow life-changing treatments.
About Biologics Consulting Group, Inc.
Biologics Consulting is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices. The company has served more than 3,500 companies in 53 countries, and in the past four years has contributed to more than 50 original INDs, 75 BLAs/NDAs (full and supported), 80 510Ks, and 42 IDEs.
About Synergy Consulting LLC
SCL offers a comprehensive package of regulatory services to manage and accelerate your drug development program. With over 25 years of experience successfully managing regulatory programs and global approval of drug, biologic and drug combination products, our senior consultants are well poised to expertly manage your regulatory needs; whether routine, challenging, precedent setting