Quality Culture has evolved into a critical component for biopharma and medical device companies since it was initially established in the early 2000s, when both regulatory agencies and industry were focused on increasing quality throughout the entire life cycle of product development. It has become clear that, whatever an employee’s position is – from technician to C suite executive – every department of the company should be built around quality so that the end goal is to ultimately provide the end-user – the patient – a quality drug or medical product.
Over the past 10-20 years, companies have developed the work required to develop a Quality Culture; some have accomplished this, but some have not. Initiatives taken to advance towards Quality Culture include working on regulatory deficiencies and all issues that can trigger the receipt of FDA warning letters; these initiatives require hard work to actually equate all work done to true Quality Culture. Everyone in the organization must be fully knowledgeable about quality; the quality concept must be instilled as a critical requirement in their jobs.
In addition to ensuring training and educating all employees on the importance of Quality Culture, another challenge, especially for older companies, is bringing their facilities thoroughly up-to-date, including equipment, computer and document management systems, digitalization, etc.; that can be costly and time-consuming. New facilities and those being planned should focus particularly on current and future trends, equipment, and digital capabilities.
For a solid 25 years, PQE Group has been tackling these challenges head-on. But this year, they’re stepping up their game with some slick docu-videos delving into the vital realm of Quality Culture. Picture this: shining a spotlight on everyday heroes – patients leading ‘normal’ lives, courtesy of cutting-edge meds and devices. Prepare to uncover the origin story of the ‘Q’ factor straight from the company DNA, revealing why it’s an absolute game-changer.
The question to you, reader, at this point is: Does your Company have the “Q factor”? Find the answer through the story of :
Eva – “Veterinarians: Ensuring Quality Care for Animals”
Eva, a Tuscan veterinarian, has a special bond with pets and livestock. Her work is a source of love and fulfillment, but it also carries great responsibility: identifying diseases and conditions and ensuring the administration of correct and high-quality medication. For animals as well, the Quality Culture intrinsic to the medication they take is invaluable.
Alessandro – “Learning to Hear at 30” –
Alessandro has recently emerged from a world of silence, thanks to a cutting-edge cochlear implant. We’ll delve into how top-tier medical devices, like Alessandro’s implant, can profoundly enhance patients’ lives. The documentary highlights the vital role of quality culture within companies to guarantee dependable and impactful products. It showcases the fusion of technology and corporate dedication in delivering transformative medical solutions. Join us on this journey celebrating hope, progress, and the imperative of investing in innovation for a better tomorrow.
Elisabetta: “Elevating Hope: Advocating for Cannabinoid Therapy”
Elisabetta is an amazing Italian woman affected by several pathologies, including Arnold Chiari, Ataxia, and Small Fiber Neuropathy, which cause chronic pain, tremors, and severe headaches. Having experienced significant benefits from using medical cannabis, she has long been advocating for institutions to recognize the importance of cannabinoid therapy. It’s crucial to highlight the significance of managing medical cannabis across all stages and ensuring Quality Culture to deliver the best possible product for patients.
Be sure to visit PQE Group’s Quality Culture page to view these informative, and important, videos to stay on top of new and exciting industry developments that utilize Quality Culture clicking on the QR Code here below!