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:
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.
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.
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.
