• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    Anumana's ECG Pulmonary Hypertension AI Algorithm Gains Breakthrough Status

    inHEART's 3D Cardiac Modeling Tool Earns FDA Nod

    FDA OKs RapidAI's Pulmonary Embolism Triage, Notification Tool

    Kilo Health Invests 500,000 Euros in Pulsetto

    China to Strengthen Robotic Surgical Market With Second 5-Year Plan
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Injecting Neurostimulators into Blood Vessels (We Swear, It’s Not Sci-Fi)

    Understanding the Costs of Care in the OR

    Sick of Being Sick: Pandemic Fatigue Flares at AAOS

    Managing Critical Healthcare Supply Chains in Turbulent Times

    To Drive Value, Human Capital Leaders Turn to Outsourced Solutions
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Arthur G. Russell Co. Inc., The

    BMP Medical

    Fusion Biotec Inc.

    Trademark Plastics Inc.

    Concise Engineering
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    3D Printing in Dental Prosthodontics, Orthodontics, and Surgery

    What New Tech Can Improve Your Medical Manufacturing Plant?

    Why Medical Device Firms Must Navigate the Muddy Waters of ESG Requirements

    Medical Device Servicing vs. Remanufacturing

    Digital Marketplaces for Medical Equipment Come of Age
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Arthur G. Russell Co. Inc., The

    BMP Medical

    Fusion Biotec Inc.

    Trademark Plastics Inc.

    Concise Engineering
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Columns

    Professional Development for the Quality/Regulatory Professional

    ...

    Professional Development for the Quality/Regulatory Professional
    Related CONTENT
    • Maintaining Compliance in the Digital Age
    • 10. Baxter International
    • Selling Regulatory Compliance
    • 23. Edwards Lifesciences Corp.
    • The State of Supply Chain Risk
    James A. Dunning, Principal, QPC Services LLC10.16.18
    Recently, someone asked me if colleges offer degrees in quality. I replied that many schools do indeed offer undergraduate programs in quality management or other quality focus areas, but such diplomas are rare among quality or regulatory professionals (most have degrees in related engineering, science, or technical areas).

    The question, however, made me think about the various education and training options for “new” quality/regulatory professionals who are just beginning their careers. Many opportunities exist for these individuals, ranging from professional organizations and universities to industry groups, mentorships, and certification programs.

    Numerous organizations offer professional development programs, but only a few will provide the inexperienced quality/regulatory specialist with the proper training. These organizations should be chosen based on an individual’s education, experience, industry focus (medical device, diagnostics, pharmaceuticals), and career choice (quality, regulatory, or both). Obviously, no professional development course will check every box, but quality/regulatory newbies can still gain valuable knowledge through a combination of programs from different organizations. Some recommendations follow:

    Colleges and Universities 
    Many schools offer undergraduate degrees and certificates in quality assurance and/or regulatory affairs. This option is clearly very valuable for individuals given both the time and (financial) resources to focus on the courses. Some companies will even reimburse employees for continuing or furthering their education/training.

    Industry Organizations
    There are many sources in this category, but I can focus only on a few.

    The Regulatory Affairs Professional Society (RAPS) offers a litany of professional development options to the regulatory professional. Chief among them is the Regulatory Affairs Certification (RAC)—a certificate that documents competency in regulatory affairs. RAPS offers certificates in regional focus areas like the United States, European Union, Canada, Global); the group also maintains specific educational/experience qualifications for those interested in becoming a qualified RAC candidate (all certifications require passing a test). The qualifications are available at www.raps.org, specifically in the 2018 RAC Candidate Guide.  

    The RAC is not the only professional development option offered by RAPS, though. Other alternatives include programs in regulatory competency, salary negotiations, business training, and in-person training.

    RAPS has a comprehensive library of books, articles, and regulatory affairs training materials, the latter of which are mostly fee-based. The Rockville, Md.-based group holds regional chapter meetings as well as large-scale events. Its annual conference is dubbed “Regulatory Convergence” and features several days of workshops on medical device regulatory strategies, the de novo process, shifting compliance-to-quality mindset, and the EU MDR.

    Like RAPS, the American Society for Quality (ASQ) offers membership to interested parties, and holds both chapter meetings and large-scale educational events. Its professional development offerings are mostly fee-based and focused solely on quality. ASQ has various divisions that members can join; the two that I have found most beneficial are the Quality Management Division and the Food, Drug, and Cosmetic Division.

    ASQ also has a plethora of certifications. There are qualifying programs for those interested in becoming a certified biomedical auditor; calibration technician; HACCP auditor (Hazard Analysis and Critical Control Points); manager of quality/organizational excellence; quality auditor, quality engineer, quality inspector, or quality technician; reliability engineer; Master Black Belt; pharmaceutical GMP professional; quality improvement associate; quality process analyst; software quality engineer; supplier quality professional; Six Sigma Black Belt; Six Sigma Green Belt; and Six Sigma Yellow Belt.

    ASQ has specific education and experience qualifications for candidates in its certification programs. In addition, the organization has thorough libraries of books, articles, and standards that it sells from its website.

    The International Society for Pharmaceutical Engineering (ISPE) is a great source of professional development for medical device industry employees who traverse the pharmaceutical sector or are focused on combination products. Like its medical device counterparts, ISPE is membership-based, conducts regional meetings and large-scale events, and offers courses on quality, regulatory, and technical. It also publishes guidance documents on Good Automated Manufacturing Practices (GAMP), and offers its members educational/professional development courses, books, standards, and guidance documents for a fee. 

    ISPE offers the best professional development opportunities for individuals focused on the technical aspects of quality assurance and regulatory affairs. 

    The Parenteral Drug Association (PDA) serves the pharmaceutical industry, offering quality/regulatory professionals training courses, books, guidance documents, and articles for purchase. Like the aforementioned groups, PDA is membership-based and has various chapters. It is a very good professional development source for those seeking expertise in sterilization and aseptic processes. 
    The Center for Professional Innovative Education (CfPIE) is designed to serve those in the pharmaceuticals and biotechnology, medical devices, and skin and cosmetics industries. CfPIE offers training and certification; its medical device focus areas include best practices, clinical trials, design control principles, document management, U.S. Food and Drug Administration compliance, process validation, qualifying suppliers, and quality principles.

    CfPIE has a similar list of training topics for the pharmaceutical/biotech sector and the skin/cosmetic sectors. The Malvern, Pa.-headquartered group also offers medical device compliance, GLP (Good Laboratory Practice) facility, and GMP (Good Manufacturing Practice) certifications.

    As with most professional organizations, CfPIE requires memberships from interested parties and charges for its professional development courses and certifications.

    Non-Industry Sources
    The development opportunities discussed so far deal mostly with the technical and/or scientific aspects of the quality/regulatory field. But the business side of the profession cannot be ignored, as most quality and/or regulatory executives work for companies—whose main mission is to turn a profit. Thus, a business education is also a necessary component of any professional development path, even for government or not-for-profit workers.

    Many new quality/regulatory specialists may have a good foundation in business, having earned an MBA or a similar degree, and some may even have management experience. Such preparation is a rarity, though—most individuals in this field lack a solid business background or administrative exposure. Although business school might seem like a logical solution for these folks, it’s not a practical one. There are less comprehensive alternatives that offer value-added training. Some examples are:
    • Dale Carnegie
    • Certificates or executive training at community colleges and universities that provide short-term concentrated guidance. Northwestern’s Kellogg School of Management is one of many schools that offer professional development programs.
    • The Deming Institute provides well-rounded training in quality management.
    • Sandler sales training is an excellent instructional source. I have long been an advocate of training quality and regulatory executives in basic sales concepts. 
    Experience is important, too. New quality and regulatory professionals can undergo extensive training, but they also need real-world experience. Mentorship, therefore, is one of the greatest gifts a veteran quality and regulatory executive can provide, as it will mean more to rookies than most of us will ever know.
     
    Failure is a valuable educational tool as well. The sting of failure will cement the learning experience for new quality and regulatory professionals. However, mentors must guard against big failures, as that could discourage unseasoned pupils and potentially endanger patients (the ultimate customer) and other stakeholders. 

    As I mentioned earlier, business fundamentals should be a key component of any regulatory and quality professional development plan, since these individuals are an integral part of most corporate business models. Now, more than ever, newbie regulatory and quality professionals must have a solid understanding of business and how their roles fit into the overall company puzzle. The ability to influence peers and superiors is key to succeeding in the regulatory and quality profession. Knowing how to present a regulatory or quality case in simple business terms (financial terms mostly) is a valuable skill that should be mastered well before one reaches the management level. 

    Quality and regulatory professionals do have an important job and add value to healthcare organizations. Hence, professional development is essential to sustained corporate success. The medtech industry is changing at a rapid pace, with new technology and clinical applications being discovered and developed every day. Regulatory requirements are evolving as well to keep pace with technological advancements and changing reimbursement environments. The industry is in constant flux, from digital health innovations and the Internet of Things to the pursuit of harmonized global requirements. We have to work smarter rather than harder; we have to be fast but comprehensive. We must be innovative while maintaining a solid foundation. Professional development is one of the tools that will help us do these things successfully. 


    James A. “Jim” Dunning’s consulting career began in 2001. He has provided quality and regulatory consulting services for various companies ranging from Fortune 500 medical device firms to startups. Dunning’s passion, however, lies with startups and small companies, especially those in regulatory distress. He has amassed significant experience in preparing 510(k) applications, developing complete Quality Management Systems, providing Quality System Training, and advising on quality, business, and leadership issues. Dunning is a senior member of the American Society for Quality (ASQ) and a member of the Regulatory Affairs Professional Society (RAPS). He can be reached at jdunning@qpcservices.com. 
    Related Searches
    • Software
    • Materials
    • gmp
    • biomedical
    Suggested For You
    Maintaining Compliance in the Digital Age Maintaining Compliance in the Digital Age
    10. Baxter International 10. Baxter International
    Selling Regulatory Compliance Selling Regulatory Compliance
    23. Edwards Lifesciences Corp. 23. Edwards Lifesciences Corp.
    The State of Supply Chain Risk The State of Supply Chain Risk
    13485:2016—Beyond the Risk Management File 13485:2016—Beyond the Risk Management File

    Related Content

    • Maintaining Compliance in the Digital Age

      Maintaining Compliance in the Digital Age

      ...
      James A. Dunning, Principal, QPC Services LLC 09.07.18

    • 10. Baxter International

      10. Baxter International

      ...
      07.26.18

    • Selling Regulatory Compliance

      Selling Regulatory Compliance

      ...
      James A. Dunning, Principal, QPC Services LLC 07.26.18


    • 23. Edwards Lifesciences Corp.

      23. Edwards Lifesciences Corp.

      ...
      07.26.18

    • The State of Supply Chain Risk

      The State of Supply Chain Risk

      ...
      James A. Dunning, Principal, QPC Services LLC 06.04.18


      Trending
      • Quality Management Evolution: What to Expect in 2022
      • Dexcom Reportedly In Talks To Acquire Insulet | Medical Product Outsourcing
      • Shrinking Medical Devices Create Sizable Challenges For Micromolders | Medical Product Outsourcing
      • 5 Ways Plastics Revolutionized The Healthcare Industry | Medical Product Outsourcing
      • Prometheus Group Sued Over Reused Catheters And Rectal Sensors | Medical Product Outsourcing
      Breaking News
      • Anumana's ECG Pulmonary Hypertension AI Algorithm Gains Breakthrough Status
      • inHEART's 3D Cardiac Modeling Tool Earns FDA Nod
      • FDA OKs RapidAI's Pulmonary Embolism Triage, Notification Tool
      • Kilo Health Invests 500,000 Euros in Pulsetto
      • China to Strengthen Robotic Surgical Market With Second 5-Year Plan
      View Breaking News >
      CURRENT ISSUE

      May 2022

      • Cybersecurity Challenges Leave Medical Device Makers Insecure
      • Contract Design for Medtech
      • Diabetes Medical Device Technology Update
      • Medtech Full-Service Outsourcing Q&A 2022

      Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
      You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

      • About Us
      • Privacy Policy
      • Terms And Conditions
      • Contact Us

      follow us

      Subscribe
      Nutraceuticals World

      Latest Breaking News From Nutraceuticals World

      Thorne Relaunches Gut Health Test with Microbiome Wipe
      Alkemist Labs Announces Alkemist Assured Seal and Next Generation Transparency Reports
      GC Rieber Foundations Expand Philanthropic Efforts
      Coatings World

      Latest Breaking News From Coatings World

      PPG Sets Goals to Reduce Greenhouse Gas Emissions, Unveils 2021 ESG Report
      Birla Carbon to Present Sustainable Carbon-based Solutions at PaintIndia 2022
      BTC Europe, NXTLEVVEL Biochem to Distribute Biobased & Biodegradable Solvents in Europe
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      Anumana's ECG Pulmonary Hypertension AI Algorithm Gains Breakthrough Status
      inHEART's 3D Cardiac Modeling Tool Earns FDA Nod
      FDA OKs RapidAI's Pulmonary Embolism Triage, Notification Tool
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Corealis CDMO Completes Deal with ArchiMed
      Piramal Pharma Solutions Upgrades Oral Solid Dose Capabilities
      Steriline Robotic Applications to Improve Quality in Drug Primary Packaging
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      L'Oreal CEO Nicolas Hieronimus On Sustainability Initiatives
      Glossier Announces New CEO
      Men’s Skincare Market to Hit $13 Billion by End of 2022
      Happi

      Latest Breaking News From Happi

      IFSCC Extends 2022 Early Bird Registration
      Incorrect INCI Prompts Recall of Higher Education Vegan Lip Balm
      Hipdot Launches Girl Scout Cookie-Themed Makeup Collection
      Ink World

      Latest Breaking News From Ink World

      HP Indigo Reaches 2,000th Active Install
      Siegwerk Introduces New NC-Based Flexible Packaging Ink
      Sun Chemical Expands SunColorBox with SunConnect
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      AWA to host 22nd Global Release Liner Industry Conference & Exhibition
      Domino assists Grace Label with supply chain disruptions
      Rotocon wins AI Business Excellence Award
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Thorne Relaunches Gut Health Test with Microbiome Wipe
      Thinx Names Meghan Davis as CEO
      Kimberly-Clark Reportedly Examining Sale of Latin American Tissue
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      Extremity Medical Rolls Out OMNI Stable Ankle Fracture System
      James W. Stone Named AANA President
      Tom Hedman Named Senior Principal Scientist at Spinal Simplicity
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      Canatu Receives IATF 16949:2016 Certification
      Applied Materials Announces 2Q 2022 Results
      ams OSRAM Supervisory Board to Elect Dr. Margarete Haase as Chairwoman

      Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

      AD BLOCKER DETECTED

      Our website is made possible by displaying online advertisements to our visitors.
      Please consider supporting us by disabling your ad blocker.


      FREE SUBSCRIPTION Already a subscriber? Login