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Biotech, Pharma and Medical Device Product and Process Development, Scale-up & Commercialization
His approach to process validation is that PV begins at the process development phase. A process that is well understood, well defined as per the critical to quality attributes with an understanding of the variable interactions prior to the definition…
Critical Care Nursing, Nursing Student Liability, Critical Care Technology
After 30 years of clinical practice, as well as her recent teaching experience, she feels confident to describe herself as a "expert" in critical care nursing. Although there is always so much to learn, she feels she makes a most…
Infectious Disease, Immune Deficiencies, Molds, Toxins, Acupuncture and Integrative Medicine
Expert’s expertise as an internist combines Internal Medicine and Infectious Disease with Medical Nutrition. As such, she is well equipped to recognize and manage challenging medical conditions, especially in those with different types and degrees of weakened immunity. A graduate…
Quality Assurance, Regulatory Affairs, Marketing and Business Strategy for Life Sciences Industry
He has performed compliance audits to 21 CFR Part 11. He has developed qualification protocols to test systems compliant with 21 CFR Part 11. He has developed advertising campaigns, written copy for advertisements and managed the creative development of advertisements.…
Pharmaceutical Facilities, Pharmaceutical Manufacturing Processes, Facility FDA Compliance
In addition to having primary responsibility for numerous pharmaceutical construction projects over the last 15 years, Expert has also held several positions with pharmaceutical and medical device companies where he was responsible for the daily operations of facilities engineering, maintenance,…
Litigation Support, Sentencing Mitigationt, Expert Testimony, Due Diligence.
Law enforcement officials in this country are, by statute, vested with more authority than the President of the United States. Simply, they are the only individuals who can initially deprive a person of their personal freedom without due process and…
Cleanrooms, Contamination Control, Ultrapure Media, Qualification and Validation, GMP, AMC
Expert has been active in aersol physics for more than 25 years. His PhD covers also the areas of environmental, indoor and cleanroom aerosols. He worked in a variety of scientific and technical projects covering the health effects of particles…
Medical Device Regulatory Support, Medical Device Registration, etc.
Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new product introductions. A committed professional…
Pharmaceutical Imaging, Biological, Physical and Analytical Research, Pharma Commercial Viability
He served as the CEO, President of two public companies, one private company and also as the Chairman of the Board of a Not-for-Profit. His experiences include: managing research, clinical studies, finance, managing personnel, legal issues, patent issues, restructuring companies,…
Emergency Medical Services, Dispatch, Emergency Preparedness, Disaster Response
LP, EMSI, CHS-III Expert has 34 years of experience providing services, management consulting and education and training in public safety and emergency management. He has received extensive education in Emergency Services and Public Policy (fire, police and emergency medical services)…