A lack of training and experience in good clinical practice and good documentation requirements has, in some cases, been determined to be the root cause of poor documentation. This has led to FDA 483 warning letters being issued.
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Paramus, New Jersey (PRWEB) March 24, 2015
“Excellence in training is a critical factor in the equation to improve the quality professionals working in the clinical research and pharmaceutical industry are able to provide. A lack of training and experience in good clinical practice and good documentation requirements has, in some audits, been determined to be the root cause of poor documentation. This has led to FDA 483 warning letters being issued,” says Christina Carmichael, Managing Director for the BioPharma Institute. “The twenty newly accredited, high quality, web-based eLearning courses are critical to ensure ethical research, high quality documentation, and credible data. In addition, they now provide the added value of including CPD (Continuing Professional Development) points for those required by their employers to complete the training. This is a win-win for everyone.”
The BioPharma Institute is best known for its online training designed for the medical device, clinical research, pharmaceutical regulatory affairs, and drug manufacturing industries. In addition to providing training programs for professionals in the industry, the BioPharma Institute also distributes books and offers access to free abridged courses. Furthermore, corporate training managers have access to real-time reporting and can rest assured knowing that training records are maintained and archived, indefinitely.
“Our continuing professional development courses provide the framework for a systematic and ongoing process of education,” explains Carmichael. “Our in-service training, learning, and support activities are all designed to build on a professional’s initial training/education and ensure continuing competence.”
BioPharma Institute Training Helps Move Medicines to Mainstream
Some of BioPharma Institute’s newly accredited courses focus on good clinical practices, from approval, through design, monitoring, evaluation, audits, and pharmacovigilance. Others teach the intricacies of new drug application to marketing authorizations, with an emphasis on region-specific variations.
“Workers in healthcare, pharmaceutical regulatory affairs, and clinical research industries are on the front-lines of a constantly shifting landscape,” explains Carmichael. “The goal for educators is to help employees stay current with their knowledge so they can effectively move health-related discoveries out of the lab and into the mainstream where they can help people.”
Clinical Research & Pharma Pros Score Points for Continuing Ed
Upon completion of each of the BioPharma Institute’s accredited training courses, participants receive CPD points. The points are awarded by the Faculty of Pharmaceutical Medicine (FPM) of the Royal Colleges of Physicians of the United Kingdom. CPD points are desired by healthcare providers such as doctors working as investigators and nurses working in clinical research associate or coordinator capacities.
The FPM is a professional membership organization and standard-setting body whose members work in diverse environments including clinical trials, pharmaceutical marketing, and the regulation of medicines.
Making Continuing Professional Ed the Rule, Not the Exception in Healthcare
Carmichael notes that most countries do not have strict legal requirements regarding the continuing education of biotech, healthcare, and pharmaceutical professionals. In those instances, the drive for continuing education must be initiated, provided, and promoted by:
- Medical associations
- Professional organizations
- For-profit healthcare companies
- The pharmaceutical/medical technology industry
- Consumer organizations
- Academic institutions
- Non-governmental organizations
- Ministries of health
- For-profit CPD providers (including the BioPharma Institute)
“Changes come at lightning speed in quickly evolving industries such as healthcare, biotech, and pharma,” says Carmichael. “You can take steps to grow and evolve, or you can stay the same and ultimately become obsolete. The BioPharma Institute’s mission is to provide relevant and current training for these industries, worldwide.”
About The BioPharma Institute
The BioPharma Institute, located in Paramus, New Jersey, offers convenient, efficient, and effective training solutions targeting the continuing professional development needs of those working within the pharma, clinical research, biotech, and healthcare industries. Since its establishment in 2003, the BioPharma Institute has worked to aggregate a comprehensive offering of web-based courses, books, and other training tools. For more information regarding the BioPharma Institute, its course offerings, and other services, you may call (888) 4-BIO-LRN or (201) 301-8370, or use the website contact us form.