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...

Radiopharmaceutical Consultant Specific To: QA, QC, GMP, GMP internal Audits, Health Canada GMP Inspections and ExpertRadiopharmaceutical industry experience ranging from, Quality Assurance, (QA) Quality Control (QC), Good Manufacturing Practice (GMP), GMP internal audits, Health Canada GMP inspections, deviation handling and implementation of Corrective and Preventative Action (CAPA), change controls stability program, and validation. Oversee fast-paced radiopharmacy production environment. Quality Assurance Manager, applying over15 years of global experience in the radiopharmaceuticals industry. Demonstrated extensive and consistent...

Medical Device, Medical Drug Delivery Design and Development for the Biotechnology and Pharmaceutical IndustriesAccomplished engineer/scientist with over 35 years’ experience in the design and development of drug products, pharmaceutical manufacturing processes and medical devices. Successful track record of progressing products from lab bench to commercialization. .Technical Competencies Drug product development and characterization, Process development and scale up, Project management, Identifying and managing vendors, CROs, CMOs, Tech transfer & trouble-shooting, Authoring CMC regulatory submissions, Development of micro-...

Analytical chemist expert in development, validation and transfer of methods for pharmaceutical regulatory filings such as IND, ND, NDA, eCTDSeparation science HPLC, ion chromatography, chiral HPLC, GCAnalytical method development and validation analytical method technical transferLaboratory equipment and instrument qualification and calibrationDesign and setup of GMO and GLP Analytical LaboratoriesRaw material and drug substance characterizationPhysical chemical characterization and structure elucidationProject management for bioanalytical and analytical laboratoriesBioanalytical method developmentQuality assurance for GMO and GMOP labora...

Biologics Pharmaceutical Development and Manufacturing Consultant for Clinical and Commercial Products. Formulation Development Work and Stability Testing, from Early Stage Through Commercial, for Proteins, Monoclonal Antibodies, Vaccines and Small Molecules.Biologics pharmaceutical development and manufacturing, working in process development, purification, formulation, lyophilization, analytical development and stability for both clinical and commercial products.Formulation development work and stability testing, from early stage through commercial, for proteins, monoclonal antibodies, vaccines and small molecules.Sterile fill support f...

Seasoned engineer in pharmaceutical, biotechnology and medical devices manufacturing capital projects, processes and facilities compliant with GMP, FDA and ISO requirements.Capital project implementation, in GMP, FDA and ISO environments through design, construction, commissioning, validation of manufacturing facilities, processes, equipment, and multi-tasking.Oversight of project, process, plant, facilities engineering and architecture and engineering contractors.Engineering support to identify, troubleshoot problems and provide a cost effective solution to maintain and increase productivity.Strategic planning leadership for process impro...

Biological Manufacturing: Auditing, Root Cause Analysis, Corrective, Preventative Action and GxP compliance. Biological and clinical manufacturing operations executive, providing a wide range of experience in quality leadership across many facets. Create, develop and recommend program and system changes pertaining to vaccine product release and deviation management resulting in more efficient product release to market and improved "right-first-time" manufacturing metric. Articulate leader with unparalleled work ethic coupled with a strong sense of urgency, keen interest and passion in making quality a key ingredient to the success of...