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...

Ph.D. Biochemist Specializing in Protein Purification and CharacterizationProtein purification and refolding.NMR and Crystallography protein purification using LC-MS to characterize proteins.Over 40 years of industry experience in drug developmentCurrent GMPSpecializing in developing new and very effective purification methods.Specializing in assay development.Purification of human insulin and Insulin analogs.Human monocyte/neutrophil elastase inhibitor, developed the expression of MNEI in E coli.Undisclosed Company, President and Founder, 2006 - 2013Acquired facilit...

Ph.D. Synthetic Organic and Analytical Chemist skilled in FT-NMR, FT-IR, UV/Vis and Mass Spectrometric Methods for Purification and Separation Organic CompoundsStructural characterization and qualification of pharmaceutical API's, intermediates and metabolites using both 1H and 13C-NMR.Deformulation analysis of generic and pharmaceutical products.Stereospecific of chirally pure herbicides and fungicides.Facile synthesis of a series of novel Class II Mesoionic Xanthine Acyclonucleosides.Purine nucleoside analogs.Synthetic method for the preparation of the Dopamine-1 receptor antagonists SKF-85366 and SCH-23390.Synthesis of 18F-Spiperone a...

Drug Stability, Pharmaceutical Impurities, and Control Strategies ExpertChemical, physical, and environmental stability and degradation.Preformulation, formulation design and stability.Analytical and impurity (including mutagenic impurity) control strategies, including structure elucidation, characterization, predictive technologies and risk assessment.Photostability, photochemistry and photostabilization.Regulatory issues and authoring, primarily chemistry, manufacturing and controls section.Expert Witness ExperiencePatent case in Europe, regarding differences in stability between prasugrel and clopidogrel, and testified as Expert Witnes...

Pharmaceutical Manufacturing Production Consultant in QA/QC, GMP, Root Cause Analysis, Non-Conformance (NOE) InvestigationsPharmaceutical industry Good Manufacturing Practices, (GMP) and ISO Standards.Ability to manage multicultural environments, motivate staff members and implement company objectives.Diverse manufacturing and compliance activities.TPS tools, Lean, Six Sigma and Toyota Kata.Latin America experienced. Bilingual, Spanish and English.Undisclosed Company, Manufacturing - Quality, 2014 - 2015Director of O...

Pharmaceutical API and QA Consultant with Expertise in Steroids and Norsteroids Manufacturing. Lean Management, Validation, FDA InspectionsActive Pharmaceutical Ingredient (API) manufacturing and quality assurance, successful scale-up, technology transfer and quality assurance projects.Steroid plant operations; training, FDA inspections, and manufacturing.Lean management in API manufacturing.Quality assurance management; release operations in packaging processesAPI manufacturing - steroids and norsteroids.Pharmaceutical products scale-ups and technology transfers.Qualification of equipment (reactors, centrifuge, dryers etc.) and utilities,...