Quality Process Training


Quality Process Training is Essential to Maintaining Compliance

Keeping your quality and compliance knowledge and skills up-to-date in today's rapidly changing regulatory environment requires extraordinary effort. To stay current, best-in-class life sciences and manufacturing companies often rely on the expertise of external quality process training consultants or quality management consulting firms. Finding an experienced consultant or firm that not only understands your industry, but also your business can be daunting. It's worth the effort, however, particularly if your company lacks the time, resources, or internal expertise to develop an effective quality training program from scratch, or to verify that your existing training programs are working as well as they should (or could) be. A good quality management consulting firm can help you make sense of global compliance, and how it impacts your business.

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Effective Quality Training Should Be Based on Best Practices

Effective training, whether developed internally or externally with the help of a consulting firm, has many benefits. Certainly the biggest advantage is that it can help you maintain compliance and avoid regulatory sanctions. It's no secret that perfecting your quality processes (document control, CAPA/quality event management, risk management, audit management, supplier management, root cause investigations), using quality process training workshops based on industry best practices, will give your company the competitive edge it needs to achieve compliance success.

But what is a best practice exactly? A best practice is a method or process that has consistently produced better results than other methods or processes; it is used a benchmark. In many ways, the term "best practice" has become a business buzzword, which is why it's important to ensure, particularly when using the services of an external quality management consulting firm or quality process training consultant, that they truly understand your business and the regulatory environment in which it operates.

Hiring a Quality Management Consulting Firm vs. Designing Your Own Quality Process Training

Designing your own quality process training has its advantages; the biggest is the money you'll save on consultancy fees. However, it also presents unique challenges and raises important questions: Who will develop the training? Who will maintain and update it so that it's always current with the latest regulations from the FDA and other regulatory bodies? Will it be accurate? Will it consume too much time or internal resources? Ultimately, will it help you bring best practice results and remain compliant?

These concerns lead many regulated companies to enlist the assistance of an external consulting firm to help them develop their quality management processes, or ensure that their existing processes are up to par. Of course, this introduces another dilemma: what do you look for in a training consultant? Here are some things to avoid:

  • Cookie-cutter training curriculum Unfortunately, many quality management consulting firms employ a cookie-cutter approach to quality process training, even if a particular "best practice" or method is not applicable or is inappropriate for a particular organization's industry or needs. This can cause participants to disengage, assume the training isn't relevant to their needs or current processes, and miss important information.
  • Instructors who do not understand your industry and the concerns of regulated companies Avoid quality consulting firms that are short on experience in the life sciences and general manufacturing industries. In regulated industries, time is of the essence. You need quality training experts who are able to discuss your issue and training needs immediately, and understand how your business works. Avoid paying for your "experts" learning time.
  • Large classes that prohibit personalized attention When you are evaluating consulting firms to facilitate your training, be sure to inquire about class size. Larger classes do not enable you to receive the attention you deserve. Smaller classes ensure that your questions get answered.
  • Poorly defined learning objectives (or none at all) Well-written course goals play a crucial role in ensuring and measuring content mastery. Developing a set of learning objectives is essential, as it can guide participants and add clarity to teaching and learning. Best-in-class quality management consulting firms understand that the overall goal for teaching should be learning. When participants know what they should be able to do by the end of a particular quality process training course it will be less of a challenge for them to meet that goal.

Benefits of Outsourcing Your Quality Process Training to MasterControl QCC

Quality and Compliance Consulting (QCC) is MasterControl's quality management consulting division. It is comprised of a highly experienced team of QMS experts, auditors, certifiers, process engineers, and educators who not only know the life sciences and manufacturing industries inside and out, but also understand your business and the unique demands of regulated companies like yours. QCC provides guidance in seven core regulatory, compliance, and quality disciplines: regulatory acceptance/compliance , quality process training, supply chain management, validation/qualification, certification/accreditation assistance , new product acceptance, quality management systems.

Quality process training workshops are offered in the following areas: QEM/CAPA, root cause investigations, risk management, supplier management, audit management, document management and regulatory standards. Whether you're looking for limited training to improve a specific quality process, such as CAPA event management, or comprehensive help to design a closed-looped quality system, QCC can help. Here is how we differ from other firms:

  • Coursework Based on Your Company's Real Quality Processes and Work Environment Each quality process training workshop incorporates the proven QCC methodology to teach critical thinking skills that will help your organization implement and follow a best-practice system. Instructors do more than discuss hypothetical quality issues and solutions; they discuss your quality issues, within the context of your 'normal' working environment, and work with you to determine how to apply the newly learned concepts and develop a solution.
  • QCC instructors are quality process experts and former FDA auditors It's not just the interactive format that sets QCC quality training workshops apart - it's also the instructors. Unlike other quality consulting firms, every QCC trainer is a seasoned quality process expert with more than twenty years of industry experience. You'll learn from some of the industry's brightest thought leaders, professionals who've trained investigators from the FDA and hundreds of regulated life science and manufacturing organizations worldwide - and you don't even have to leave the office. Our trainers will come to you; all workshops are presented at the time and location of your choice to reduce travel costs and eliminate downtime
  • Smaller class size, more personal attention While there is no minimum class-size requirement, QCC quality process training workshops are limited to a maximum of twenty participants per class. The small class size enables our instructors to adapt the coursework, which is continually updated and refined, to participants' needs. For example, if students are already proficient in one area, the instructor will move on to another topic. Smaller classes also allow the instructor to devote more time to giving individual feedback, which increases participant confidence and participation. Few quality management consulting firms offer this level of personalized attention, at such an affordable price.
  • Clearly defined learning objectives translate to success Well-written course goals play a crucial role in ensuring and measuring content mastery. Each QCC quality process training workshop is established upon key core objectives, which are followed throughout the workshop. In addition, most courses have a testing component and certification process to ensure promised outcomes and participant improvement. The learning methodology is "adult based" and used by the FDA, Irish Medicine Board, and many other regulatory bodies. It is easy to understand and, best of all, produces immediate results.

For more information on MasterControl's Quality Process Training

For more information about MasterControl QCC's quality process training workshops, contact us today