Global Quality Expert for Sterile Injectable and Medical Devices with Extensive Experience Interacting with FDAQuality for small and large volume sterile injectable and medical devices.Quality assurance policies for sterile injectable dosage, and product assurance.Procedures for out of specification (OOS) results for analytical and biological laboratories for sterile injectable dosage.Quality investigation teams to investigate high and medium level deviations to determine root cause, implement appropriate CAPAs and check for CAPA effectiveness.New product development and sterility assurance of sterile disposable products.ISO 9001 certifica...

Ph.D. Chemical and Biochemical Engineer Specializing in Cell Culture and Sterile Drug Product Process Development, Technology Transfer, Scale-up, and Manufacture.Fermentation and cell culture development, scale-up, and manufacture.Sterile drug product development, technology transfer, and manufacture.Current good manufacturing practices (cGMP).Metabolic modeling.Educator for undergraduate Bioengineering program and workshop facilitation.Undisclosed Company, Owner, 2011 - PresentPr...

Synthetic Drug Product Development Expert - Marketing and IP Management, Including Qualification of Drug Product Manufacturers and Preparation of Regulatory FilingsMore than 30 years leadership in the pharmaceutical and chemical industry.New compounds and discoveries in chemical processes.Expertise in the chemistry of vitamin D and analogs, anti-infectives (macrolides, quinolones, HIV protease inhibitors), taxanes, peptidomimetics, and other anticancer drugs, steroids, prostaglandins and cannabinoids.

Pharmaceutical and Biotechnical Quality Assurance Consultant - Regulatory, GMP, GLP, ISO, ICH, FDA, Drug Development, Manufacturing and Aseptic Processing. PhD Consultant Specialized in New Product Research, Scale-Up, Compliance, Production Development, New Applications and CommercializationPharmaceutical and biotechnical quality assurance.Broad knowledge of GMP, GLP, ISO, ICH, FDA and International regulations.Managing multiple projects and complex priorities.Drug development, pharmaceutical manufacturing and aseptic processing principles and requirements.Focused AreasProduct releaseProduction batch recordChange controlCommissioning,...

5 - Meta Description Formulation Development and Manufacturing Technology Expert of Pharmaceuticals, Nutraceuticals and Cosmetics Multiple Delivery Platforms. Extensive Experience Working with FDA, DEA (U.S.A.) EMEA, EFSA (Europe), TGA (Australia), NHPD, and HPFBI(Canada).Formulation development and manufacturing technology of pharmaceuticals, nutraceuticals and cosmetics on any delivery platform.Analytical oriented work in solids, liquids, topical and sterile products, over the counter - OTC, non-prescription medicines, vitamins, and nutritional products.Development and manufacturing management with focus on dietary supplements, respira...

Development and Implementation of Phase-Specific Quality Systems and Pharmaceutical Production and TestingPharmaceutical quality assurance management and corporate quality strategy planning.Development and implementation of phase-specific quality systemsIdentifying and correcting road blocks to efficiency and complianceGMP facility design, construction management, validation and licensing of GMP manufacturing facilities.Proven success in U.S. and E.U Inspections of manufacturing and laboratories.Over 20 years of valuable experience developing and managing highly productive work groups in small to mid-size pharmaceutical.

Pharmacist Specializing in Asia/ India Specific Regulatory Requirements - Marketing Authorization, Clinical Trial Permission in Biologicals and Other Market Research; Pilot Plant and Pharmaceutical AnalysisDiverse experience in pharmaceutical regulatory affairs at national and international levels.Current pharmaceutical regulations in India with major regulatory authorities.Acquired training in international forums by (WHO), World Health Organization and USFDA.Working at apex drug regulatory body in India.Inspection of clinical trials.Sourcing pharmaceutical Information.

Pharmaceutical Quality Assurance and Regulatory Compliance: GMP, GAP, CMO's, FDA, EU,FDA and EU regulatory compliance.Global quality assurance in the pharmaceutical industry.GMP's - Good Manufacturing Practices.Quality systems, (CAPA, Corrective and Preventive Actions, change control, SOP's, and non-conformance investigations).483's, warning letters and consent decree remediation.GMP's audits, due diligence audits, for cause audits, and mock PAI's audits.Process improvements.Project management.GAP assessments.Sterile products, aseptic process, system simulation tests, HEPA filters, water systems testing, dry and steam sterilization.Soli...

Pharmaceutical R&D, Quality Operations and Regulatory Affairs Career Expert: Technical M&A due diligence, cGMP/QSR Compliance - Drug, Device, Combination, Biologics. Consent Decree, Warning Letter, and 483 RemediationChemistry and Manufacturing Controls (CMC).Regulatory strategy; domestic and international.cGMP compliance drug: 21 CFR 210, 211.cGMP compliance nutritional supplements/NSF Certification: 21 CFR 111.cGMP compliance drug device combination: 21 CFR 4.Quality systems regulation: 21 CFR 820, ISO 13485.Merger and acquisitions - 3rd party vendor due diligence.Regulatory filing: pre-submission review, writing: NDA, ANDA, 505(b)(2),...

Senior Pharmaceutical Professional Specializing in Global Business Development in the Healthcare Industry Focused on: Medical Devices, Drug Development, Regulatory Affairs, Quality, cGMP, FDA, Pharmaceutical and Clinical ResearchSenior Pharmaceutical Executive concentrating in medical devices, and the pharmaceutical research industries.Global pharmaceutical business development.Regulatory affairs, quality control, clinical research industries and operations.Submission preparation: IND, CTD, ANDA, NDA and MAA.Clinical research including protocol and medical writing.Strategic planning and business analysis.New pharmaceutical development and...