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