Pharmaceutical Quality Assurance Quality Control expert with experience with U.S., E.U., Canada, and India regulationsPharmaceutical Quality Assurance and Regulatory Affairs.Compliance audit, Quality Operations and Regulatory Submissions.Design and implementation of Quality Systems and regulatory compliance programs.Domestic and international quality and regulatory compliance.Managing contract / vendor supply chain quality programs.Developing and delivering GMP, GDP, DI procedure training programs.Leading the Quality efforts to successfully remediate recurring failures.Generation, maintenance and revision of SOP's, specifications, procedur...

Pharmaceutical Product and Process Development, cGMP, cGLP, FDA, Regulatory, Research and Technology DevelopmentSummary Over 15 years of pharmaceutical industry acumen, new product development through life-cycle management (post-marketing support) process, with the ability to address regulatory requirements set forth by the FDA and other health authorities. Effective problem solver with the ability to apply technical expertise and solutions to diverse situations successfully. Analytical research and development in the pharmaceutical industry. Project management. Test method development. Process development. cGMP, cGLP, FDA, and ICH...

Pharmaceutical GMP Consultant with expertise in GMP, QMS, Documentation, Validations, Plant setup, Training and development, Quality control, Audits, environmental monitoring, for Solid orals, Liquid Sterile, solid orals, liquid orals, dermal products; various dosage forms. Managing strategic and operational performance of Quality Department providing: Development and implementation, Standardized quality system processes, Review of standards for quality control, Regulatory compliance, Quality control systems and procedures (GLP). Pharmaceutical industry (Formulations). Quality Management System (QMS); Complaints, recalls, deviati...

Expert in GMP requirements for software and equipment validationSpecializes in consulting and project management for Supervisory Control and Data Acquisition (SCADA), System Integration and Industrial Controls including pharmaceutical industry regulatory compliance, 21 CFR Part 11 and controls for clean rooms. Specific expertise in :Good Automated Manufacturing Practices (GAMP).21 CFR Part 11 Training. Computer Validation Training by PDA.PLC hardware and softwarePharmaceutical Current Good Manufacturing (cGMP) and validation of computer softwareGood Automated Manufacturing Practices (GAMP) and Good Electronic Records Management (GERM) me...

Regulatory Pharmaceutical Compliance Consultant with Expertise in Clinical, Pharmacovigilance, Biologics, Biosimilars, Orphan Drug, Medical Device, Natural Health Product, Dietary Supplement, Cosmetic, and Food.Regulatory strategy, pathways and gap analyses.Regulatory submissions and applications for diverse product types to global regulatory agencies: Health Canada, US FDA and EU EMA (CTA, IND, IDE, DMF, NDS, SNDS, ANDS, SANDS, DIN, NDA, NDA 505(b)(2), BLA, ANDA, PAS, CBE, CBE-30, 510(k), PMA, HUD, HDE, Class II, III and IV Device License Applications, ITA, MAA, Type I and II variations, Technical File, PLA, Amendments, Notifications, a...

Consultant with Diverse Pharmaceutical Experience in Formulation Development, Manufacturing, Technology and Site Transfer, Process Design, Scale-Up, and ValidationPharmaceutical formulation development, manufacturing technology transfer, site transfer, process design optimization, and scale-up for domestic and international clients.Product development using QbD approach, process scale-up and optimization, process validation.Drive technology platforms such as solid and Liquid orals, aseptic filling, softgels, orally disintegrating granules, powders, MR products, X-ray contrast media, peptide injectable product, topicals, steroids and hormo...

cGMP Auditor and Expert in Chemistry Pharmaceutics (cGMP 21CFR 210,211,820, ICH Q7A), Mock Audits, GAP Analysis. Pharma and Medical Device Industries.Auditing cGMP 21CFR 210,211, cGMP 21CFR 820, and ICH Q7A.Consulting for Gap Analysis USFDA and other audits.Medical device international consulting.Conducting and organizing trainings and seminars related to Pharmaceutical and Medical device industries.Expert Witness ExperienceCompiling the U.S. norms for a warehouse located in Bhiwandi, IndiaConsulting of Pharma Company for facing USFDA Audits.

Pharmaceutical Quality Auditor and Compliance Consultant for Human Tissue, Pharmaceuticals, and Medical DevicesQuality SystemSupplier quality system audits, supplier qualification, SCAR management and non-conforming material control and disposition.Quality system design: Medical device per QSR (21CFR PART 820) and ISO13485 requirements; and pharmaceutical per 21CFR 210.Designing Quality systems per 21CFR part 1271 (tissue and cellular therapy).Writing and reviewing Standard Operating procedures, SOPs and Work Instructions.Perform quality system audits per 21CFR 820 cGMPs (medical device), 221 cGMPs (pharmaceuticals), 600 cGMPs (biomedical)...

Ph.D. with expertise in Drug Metabolism and Pharmacokinetics, Pharmacodynamics, and Toxicokinetics. Investigational New Drug approval experience in USA and ChinaDMPK (Drug Metabolism and Pharmacokinetics), PD (Pharmacodynamics), TK (Toxicokinetics), Toxicology, and Safety fields.Oversight of outsourced GLP studies and in-house non-GLP studies for candidate drugs in oncology, inflammation, anti-virus, and hypertension fields.IND (Investigational New Drug) approval both in U.S.A. and China, as well as 15 years of experience in small molecular novel drug discovery and development, and 20 years of experience in drug metabolizing genes/enzymes...

Analytical Chemistry Consultant Specializing in Lean cGMP Laboratories Operations, Methods Validation and Transfer, Quality Control Testing, OOS and Nonconformance Investigations for Regulatory and Manufacturing in Pharmaceutical and BiotechnologyAnalytical, biochemical, microbiological, and raw material cGMP testing laboratories.Implementation of robust quality systems including, test method validation and transfer, Out Of Specification (OOS) investigations, product stability program, LIMS, training program, document control, specifications, equipment qualification, raw material qualification, risk assessment, Corrective And Preventive Ac...