Dr.Zadorin Eugene, PhD, MBA
International BioPharmaceutical Association,
Lehrman healthcare Council, First Clinical Research LLC Speakers
Bureau, former head of consulting Group of the Department of Clinical Research
Current Good Manufacturing Practices (cGMP) consist of the regulations, guidelines and recommended practices issued by the FDA and other international regulatory authorities as well as current industry practice. They form the basis for production and testing of pharmaceutical products that are safe and effective for human use. Regulatory publications are necessarily vague so that manufacturers have the opportunity to incorporate innovations into their products. Thus the practitioner of cGMP must strive to be up to date on the latest innovations. cGMP compliance ensures that the products produced meet specific requirements for identity, strength, quality, and purity. FDA regulates practitioners of cGMP using the following tools:
21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, Or Holding Of Drugs; General Part
21 CFR Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals
GMP training certification is the formal recognition of clinical research professionals who have met professional eligibility requirements and demonstrated job-related knowledge and skills. The NBScience's certification is granted in recognition of documented and verified work experience and successful performance on a multiple-choice exam.
The success of the NBScience international is built on forging profitable business relationships between the Pharmaceutical and Biotechnology industries and their partners in clinical research.
With our 5 years of experience in increasing our partners' return on investment we've developed winning strategies guaranteed to build and sustain successful partnerships in clinical trials outsourcing.
NBScience already has many partnerships with societies, universities, statutory organisations and NGOs locally, nationally and internationally. We aim to strengthen these relationships and develop new collaborations in the future.