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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
On-demand recording from October 2022.
Many regulated businesses chase a baseline of compliance, setting standard accreditation and audit-passing as the primary objective of their quality teams.
But this approach doesn’t set businesses up for long-term success, or allow them to beat their competitors. As industry bodies from the FDA to the ISPE pivot from a compliance to a quality focus with their new initiatives, businesses need to consider how to treat standard compliance not as an end point, but as a springboard for continuous quality improvement.
This webinar breaks down why quality is the new compliance - and what your business needs to do to harness quality as a long-term competitive weapon.
Quality & compliance managers, Executives/directors
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
David SchonekerBlack Diamond Regulatory Consulting, LLC
David R. Schoneker is currently the President/Owner of Black Diamond Regulatory Consulting, LLC, a consulting firm specializing in providing regulatory and quality consulting for the pharmaceutical, dietary supplement, food and related industries. The firm provides expert advice for difficult problems and training on excipient and food additive regulatory, quality and supply chain concerns.
With over 45 years of experience working in these areas, Dave has developed strong networks with trade associations, regulatory agencies and pharmacopeias around the world. He is also an Adjunct Professor at Temple University's School of Pharmacy in their RA/QA Master's Program teaching courses in Global Excipient Regulations and the Regulation of Dietary Supplements.
Prior to August 2019, David R. Schoneker was the Global Regulatory Director – Strategic Relationships at Colorcon, Inc. His responsibilities included global coordination of Colorcon’s worldwide regulatory activities. He was at Colorcon from 1977 until 2019.
Mr. Schoneker was the Chairman of IPEC-Americas during the period 2007-2009 and is currently a member of the Executive Committee, the Chair of the QbD/Composition Committee and is actively involved with the development of Regulatory, Safety, GMP and Supplier Qualification related guidelines to improve Excipient Quality and Safety.
Highly accomplished Science professional with 20 years of experience providing Quality Assurance and Laboratory Management in the Preclinical, Life Science, Nutraceutical and Medical Device market spaces. Demonstrated leadership and proven ability to design, plan and implement projects from conception through completion; able to manage multiple responsibilities without compromise to detail or quality; and maintain an overview of ongoing and evolving projects. Resourceful and analytical problem solver with broad quality, regulatory and safety program management and problem solving skills!
Kelly brings over 20 years of experience in both the pharmaceutical and medical device industry to the world of small start-ups and scalable quality system implementations. Having been an implementer, administrator and user of many different eQMS tools on the market, she has built several quality systems and is an advisor to over 20 Medical Device and Pharma companies. She is currently the Director of Quality at Qualio, helping customers and the company adhere to the evolving regulatory landscape. She leads a team of talented industry-experienced quality professionals who work with companies in regulated industries on a daily basis.
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