Kim Walker Consulting

Professional Conferences
and Seminars

University of Georgia Medical Device Regulations Conference & Workshop

2022

Speaker – An Industry Perspective on Converting EUAs to De Novos and 510(k)s

Moderator – EU MDR/IVDR Workshop

MD&M West

2022

Speaker – Q-Submissions Best Practices

2021

Panelist – Insights & Experiences from the Implementation of the EU MDR / IVDR & IVDR Compliance – Strategies for Ensuring Your Product Meets Quality & Compliance Requirements

2020

Speaker – EU MDR & IVDR Compliance: Tales from the Trenches

2019

Speaker & Track Moderator & Chair – Regulatory & Quality Update & Evaluating Pre-Market Pathways for US Market

2018

Speaker – MDR & IVDR Overview

2014

Moderator – Regulatory Track Day 1

AGRE

2021

Speaker – Emergency Use Authorizations (EUAs) – Tales from the Trenches

SDRAN

2021

Speaker – RAC Exam Study Group

  • Overview of US Clinical Trial Requirements
  • RAC Exam Overview & Example Test Questions Review

2020

Speaker – Emergency Use Authorizations – Tales from the Trenches

Speaker – SDRAN RAC Exam Study Group

  • Introduction to Device & Drug RAC Exams and Study Tools
  • Overview of Drug, Biologic, Device, Combination Product or Food Regulatory Pathways
  • Quality Systems and Inspectorate Process – Pharmaceuticals
  • EU Clinical Trials – Medical Devices
  • EU Medical Device Directives Overview
  • EU MDR & IVDR Compliance
  • FDA History & Structure
  • ISO 13485:2016 Overview
  • ROW Medical Device Regulations

2019

Speaker – SDRAN CAN RAC Study Group (2019, 2018, & 2016)

  • Health Canada Organization
  • Overview of the Canadian Legislative Framework
  • Good Laboratory Practice for Nonclinical Laboratory Studies
  • GCP, Clinical Trials, Investigational Testing Authorization
  • Regulation of Products for Small Patient Populations
  • Development of Health Products for Pediatric Populations
  • New Substances Notification for Products Regulated Under the Food & Drugs Act

2017

Speaker – US RAC Study Group (2017 & 2016)

  • US Regulatory History Overview
  • FDA Communications & Meetings
  • Preparing for Key Meetings & Advisory Committees

 

Speaker – SDRAN EU RAC Study Group (2017-2014)

  • Medical Device, Combination Product, and Clinical Trial Regulations

OCRA

2020

Program Chair & Moderator

  • California Consumer Privacy Act (CCPA) Overview
  • CER/PER Best Practices
  • CA’s CCPA & EU’s GDPR – Part 2
  • Laser and X-Ray Reports and Regulations
  • ISO 14971:2019 – Quality System Impact
  • Audits, Inspections, & Warning Letters – Best Practices
  • ISO 14155:2020 – Clinical Trial Requirements Have Changed

2019

Program Chair & Moderator

  • ISO 14155:2019 – Clinical Trial Requirements Have Changed
  • How to Prepare for the IVDR & Presenter on: Overview of IVDR & New IVD Classifications
  • How to Write a 510(k)

 

Speaker 

  • What To Do Once You Get Your 510(k) Clearance – Best Practices in Placing a Product on the Market
  • What’s YOUR Company’s Future in the European Union (EU) in 2020?  EU Medical Device Regulation (MDR) Requirements & Impact on YOUR Business 
  • EU MDR Overview

2018

Speaker, Program Manager, & Moderator

  • OCRA Year in Review – Industry and FDA Trends – Lessons Learned

2017

Program Manager & Moderator

  • CAPA:  Successful Strategies for a Comprehensive Program – Regulatory Updates and Best Practices

 

Speaker, Program Manager, & Moderator

  • Pre-Market Submissions Best Practices

2016

Program Moderator & Manager

  • FDA-OCRA Annual Educational Conference – Plenary Session #3 Supply Chain Security Case Study and Panel Discussion
  • FDA-OCRA Annual Educational Conference – Clinical Trials Breakout Session #3 EU Clinical Trials: New Regulations and Operations
  • In Vitro Diagnostic Regulations Regulatory Updates and Best Practices
  • Medical Device Adverse Events Best Practices

2015

Program Moderator & Manager

FDA-OCRA Annual Educational Conference – U.S. Pre-Market Submissions – How to file and manage 510(k)s, PMAs, and De Novo applications

2014

Speaker

  • Regulatory Inspections and How to Manage Them

 

Program Moderator & Manager

  • The Secrets to Success – Pre-Subs, 510(k)s, & FDB

2011

Program Moderator & Manager

  • FDA-OCRA Annual Educational Conference – Total Lifecycle Risk Management Sessions

2008

Program Moderator & Manager

  • Combo Products
  • Validation
  • Global Clinical Trials
  • FDA-OCRA Annual Educational Conference – International Update
  • FDA-OCRA Annual Educational Conference – CDRH/FDB Update

 

Speaker

  • CAPA – A Global Perspective

 

Speaker, Program Manager, & Moderator

  • US RAC Study Group

American Medical Writers Association

2017

Speaker

  • AMWA Pacific Coast Conference – Regulatory Requirements and Best Practices for EU Clinical Evaluation Reports

San Diego State University

2014 – Present

Part-Time Instructor

  •  Instructor and re-developer for RA 773 “Medical Device Regulations” course in the Master of Science in Regulatory Affairs program

  • Guest lecturer for RA 601 “The Pharmaceutical, Biotechnology and Medical Device Industries” on the topics of combination products, introduction to medical devices, pre-market global medical device requirements, and post-market global medical device requirements

  • Guest lecturer for RA 696 “Drug/Device Product Development and Regulation – Europe and US” on topics of medical device QSR, ISO 13485, and US pre-market submissions

  • Participate on the Faculty Advisory Board and as a Faculty Advisor for student Capstone projects

Roseman University of Health Sciences

2021 – Present

Part-Time Instructor

  • Developer and instructor for MSPS 620 – “Introduction to Regulatory Affairs” course for the School of Pharmacy

California State University, Fullerton

2012 – 2013

2016 – 2021

Part-Time Instructor

  • Developer and instructor for BIOL 425 “Medical Product Development and Regulatory Affairs: Bench to Bedside” course with a focus on the HCT/P regulations for the Bridges to Stem Cell Research (BSCR) program

  • Developer and instructor for BIOL 539 “Pre-Market Submission Process” for the Clinical Trial Project Management Certificate Program

  • Co-developer and co-instructor for BIOL 535 “Regulatory Requirements for Medical Products” for the Clinical Trial Project Management Certificate Program.

University of California, Irvine College of Extended Studies

2012 – 2013

Part-Time Instructor

  • Instructor for EECS X445.26 “Regulatory Requirements for Pharmaceutical Products” course

  • Co-instructor and co-developer for EECS X432.01 “Technical Writing for the Medical Product Industry” course

California State Polytechnic University, Pomona

2015

Guest Lecturer

  • Overview of Clinical Trials, Medical Product Development Course – Biotech Graduate Level Lectures

California State University, Los Angeles

2008

Guest lecturer

  • Overview of FDA Regulations – Drugs, Biologics, and Devices, , From Concept to Market – BIOL 454L

University of California, San Diego

2008

Guest Lecturer

  • Regulatory Strategies for Combination Products with Medical Devices, Biosciences Extension Course – Advanced Topics in Regulatory Affairs

Contact Us Today

Please contact us anytime.
We look forward to hearing from you!

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