Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
Training Overview
FDA’s Plan for Modernizing webinar will consider the steps the FDA has been taken to provide different and more efficient pathways for novel technologies to receive FDA clearance or approval, e.g., the Medical Device Safety Action Plan, and recent updates to modernize and enhance the 510(k) and De Novo review processes.
In addition the Agency has further announced two additional device programs:
1) Finalising guidance on the existing Breakthrough Device Program; and
2) Plans for a new Safer Technologies Program (STeP). Each addresses one of the two existing pathways , 510(k) and PMA, to address what the FDA calls "breakthrough technologies" using less restrictive submission requirements / pathways. Such approaches require a rethinking of submission strategies on the part of industry, to benefit from the FDA's changed thinking.
Webinar Takeaway
Basic US FDA’s Expectations for the 510(k)
FDA Commissioner’s Statements on Modernizing the 510(k)
The Medical Device Safety Action Plan
The Safer Technologies Program
Draft Guidance STeP, and Breakthrough Technologies
“Beneficial iteration” and the 510(k) Proper implementation under this 510(k) “Pathway”
Meeting expectations before, during and after submission
The 21 Elements in a Traditional 510(k) with the new focus
Who Will Benefit
- Medical device companies
- Regulatory affairs specialists
- Medical device consultants
- Biomedical engineers
- Research and development engineers
- Quality professionals
- QSR professionals
John E. Lincoln (33+ year exp.)
Medical Devices / Regulatory Consultant; also pharma and dietary supplements
Saint George, Utah
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 39 years experience in U.S. FDA-regulated industries, 25 of which are as an independent consultant. John has worked with global companies to resolve regulatory issues, lead validations (hardware and software) and implement QMS/RA systems. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide. John is a graduate of UCLA.
Our Participants Testimonial
The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )
Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.
Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )
Tracey Kessler ( Director of R&D) CEL-SCI Corporation
I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )
Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma
The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )
Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals
New Medical Device Regulation (MDR 2017/745)
About World Compliance Seminars (WCS)
World Compliance Seminars (WCS) is one stop solution for all your pharmaceutical, biotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIH, EMA, as well as numerous European based national regulatory bodies.
These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical Compliance, Process Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.
The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.