Success Stories
"Fortune favors the prepared mind" Louis Pasteur
This statement has never been more true than today. But despite ever-changing FDA actions and Wall Street attitudes combining to create an air of uncertainty in the pharmaceutical, biotechnology and medical device industries, several companies continue to stand out. The secret to their success? Preparation.
Proactive Compliance: Creating a Culture of Risk Control outlines strategies for preparing your organization for success. After reading it, you'll learn the two greatest challenges biopharma employees believe they face, the four principals of behavioral change and much more. Click here to download the exclusive Proactive Compliance.
How have organizations like yours taken this information and implemented it? Following are three recent examples of how your peers have exemplified not only the will to win, but the will to prepare to win in this changing regulatory environment. PTi international's On-Site Solutions was there to provide the tools for efficient and effective product development and commercialization strategies before it was too late.
Accelerating the Approval Process:
A medical device firm from the northeast was rapidly approaching the later stages of clinical trials with an in-vitro diagnostic device. Aware of the rising rate of late stage failures, they wanted to guarantee their trials were on track with all regulations and identify opportunities to hasten the process. The client found PTi's Good Clinical Practices for Medical Device course which was being offered around the country. The training was brought in-house when the client learned they could capture significant economies of scale on pricing despite having just a mid-sized group of attendees. Post-training response from the participants was glowing: participants agreed the course was "very valuable in understanding the FDA expectations and mindset" and "almost everyone would benefit [from this course]."
Improving Communication with FDA:
A topical OTC manufacturer identified weaknesses in the core competencies of their production teams, especially in their reporting capabilities. Their Technical Training Specialist contracted PTi to provide the teams with the skills necessary to develop complete and compliant reports for FDA submission. It was determined that the Writing Reports for Failure Investigations and Process Deviations course could serve as the nucleus for this initiative. However, transforming the theoretical into the practical is a high priority for PTi and their clients. Several of the client's own Standard Operating Procedures and other internal guidelines were incorporated into the training in order to make the experience as "real-life" as possible. The results speak for themselves: 100% of the participants rated the training Very Good or Excellent. Incorporating the clients' own examples had a tremendous impact. Said one participant, "[Instructor] is very good at bringing out discussion and making it applicable to [our company]!"
Matching Innovation with Compliance:
A top-five pharmaceutical manufacturer was increasing its product pipeline in biologics and needed to expand its Chemistry Manufacturing and Controls expertise as a result. PTi provided the client with CMC training specifically developed for biopharmaceuticals. The course was successfully adapted to meet the needs of an audience with significant pharmaceutical, but no biopharmaceutical, CMC experience. All participants report that the content was appropriate for their level of expertise. They now have the confidence and ability to respond to the changing corporate focus.
The key to all these success stories is the same – your peers proactively sought out the tools and techniques to continue their departments along the road to success. PTi international On-Site Solutions provided them with the map. Customized programming to meet your specific business objectives, risk minimization through performance improvement of entire teams or departments, and economies of scale and reduced travel expenses combine to make On-Site Solutions the only choice for group training. Begin your own success story by calling (800) 303 8194 or emailing OnSiteSolutions@pti-international.com. For details on our most popular courses download our Solutions Catalog.