Overview
Medical device regulations in the EU are changing and changing fast. If your business is global, you can’t avoid these crucial adjustments.
With one extension already granted, any organization selling devices in the region now need to be ready for the shift by May 2021. There’s little time to spare to get your processes up to par — but WCS can help get you there.
Join us for the Live Webinar on Tuesday, October 12, and learn about Auditing EU-MDR and EU-IVDR Implementation. We’ll share insights on the importance of good project management methods, including those around:
- Internal Audit Programming: ISO 19011:2018 and 13485:2016
- Conformity Assessment Paths and Device-Specific Areas: QMS and RMS; Annex I, II, and III
- Applications to Notifying Bodies
- Notifying Body Approach to Audits
Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
Webinar Takeaway
The Internal Audit Program
- ISO 19011:2018
- ISO 13485:2016
- Planning, conducting and reporting
Conformity Assessment Paths
- Device Specific Areas
- QMS and risk management system (RMS)
- The Annex I documentation
- The Annex II and Annex III documentation
The Application to the NB
- The NB Approach to the Audit
Integrating NB Approach with Internal Audits
- Conducting a mock audit
The deadlines for these new regulations are approaching quickly. Don’t miss this chance to gain expert advice on what can become a complicated, difficult, and long process—and do it all from the comfort of your own home.
Who Will Benefit
- Regulatory compliance personnel
- Quality managers and directors
- Quality engineers
- Risk management specialists
- Regulatory managers
- Design engineering managers
- Supply chain managers focused on procurement and distribution
- Production managers and engineers
- Document control specialists
- Marketing managers
- Clinical managers
- Clinical evaluation specialists
- Export compliance managers
David R. Dills
Global Regulatory Affairs & Compliance Consultant
David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA and IDE submissions, serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification.
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
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.