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Validity : 13th Apr'24 to 23rd Apr'24
US FDA’s 2019 - 2020 Strategic Priorities
- Key FDA strategic priorities – past, present and future
- FDA’s areas of emphasis
- Translating FDA priorities to company CGMP priorities
- A company’s QMS, CGMP compliance and high risk concerns
- Specific actionable areas for regulated industry
- Periodic Management Reviews – tying it all together; taking it to the next level
Overview of the webinar
In their latest strategic priority cycle, the FDA has committed to reduce the time and cost required to bring a product to the U.S. market and support it throughout its life cycle while not compromising reasonable assurance of safety and effectiveness. To achieve this goal by advancing a total product life cycle approach (TPLC), using flexible, patient-centered benefit-risk paradigms, collaborating more with FDA customers, streamlining FDA processes, and applying a least burdensome approach. A goal is helping innovators choose the U.S. marketplace, rather than be stymied by a complex and cumbersome regulatory process. At the same time, preserving safety and efficacy standards and the need for rigorous science. A key FDA metric.
By December 31, 2020, more than 50 percent of manufacturers of novel technologies for the U.S. market to bring their devices to the U.S. first or in parallel with other major markets.
Who should attend?
- Regulatory Affairs
- Quality Assurance
- Complaints Administrator
- R&D
- Engineering
- Production Supervision
- Senior Management
- Marketing
Why should you attend?
It is important to know what the FDA intends to focus on in coming months; what they view as most important in fulfilling their mandate to ensure the public’s health and safety. This knowledge helps companies in a regulated industry to better understand the CGMPs and their correct interpretation, part of the “C” (current) in CGMPs. Reviewing a company’s QMS against the current FDA’s expectations assists in better, proactive compliance.
Faculty - Mr.John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 27 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.