Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Overview

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical documentation File Table of Contents; The importance and usefulness of the "General Safety and Performance Requirements" (the old "Essential Requirements"); Structure of the "Declaration of Conformity"; self-declaring changes and/or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.


Why Should You Attend

One of our most popular webinars, continuously updated with the latest U.S. FDA and European Union requirements. As U.S. companies go global, they must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical Documentation (TD). Currently they serve different purposes, support different goals, but the TD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TD, while each serve differing goals. And how / where do the DMR and DHR fit? Being aware of the similarities and differences in the files and their individual documents can further concurrent development and/or updates to both. "


Webinar Takeaway

  • The EU's MDR and the Technical File / Design Dossier
  • Device Classification - U.S. FDA vs. EU MDR
  • Design Control 'Over Time' vs. a Product's 'Snapshot in Time' - Differing Philosophies
  • DHF "Typical" Contents and Deliverables
  • The DMR and DHR / Lot / Batch Record
  • TF / DD Required Contents
  • Parallel Approaches to Documentation - Teams
  • FDA and NB Audit Focus

Who Will Benefit

  • Senior Management in Drugs, Devices, Biologics, Dietary Supplements
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Marketing


FDA Faculty John E. Lincoln

John E. Lincoln

Medical Devices / Regulatory Consultant; also pharma and dietary supplements

Saint George, Utah

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.

Choose a Purchase Option


$199

Live Webinar - Single Participant

You get one log-in for the live 60-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email

$499

Live Group Up to 5 Participants + 12 month access

You get 5 log-in for the live 60-minute webinar for all the participant, presentation materials and the opportunity to ask questions by phone and email. 12 month Recorded Access is Included

$695

Live Group Up to 10 Participants + 12 month access

You get 10 log-in for the live 60-minute webinar for all the participant, presentation materials and the opportunity to ask questions by phone and email. 12 month Recorded access is included

$299

Recorded Access Single Participant

You'll have 12 month single user access to log-in for an archived recording of the entire 60-minute webinar, including the Q&A period . You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$499

Recorded Access Corporate Group

You'll have 12 month group access to log-in for an archived recording of the entire 60-minute webinar, including the Q&A period . You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

 

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 pharmaceuticalbiotechnology 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 NIHEMA, 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 ComplianceProcess 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.

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