Director or Sr. Directr or VP
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VIPULCHANDRA (VIPUL) DHOLAKIA, Ph.D. 12447 Great Park Circle, #110 Germantown, MD 20876 Email: [email protected] Tel: Res. (240) 477-5419 Cell: (630) 544-1748 PROFESSIONAL PROFILE Pharmaceutical professional with progressive and diversified experience in Quali ty/Validation, Technical Services, cGMP, CMC review, Analytical and Product Deve lopment, pharmaceutical manufacturing, packaging, quality control, FD&C Act, reg ulations, compliance policies and procedures. Experience with bulk pharmaceutic als (API), liquid oral, solid oral, nasal, and topical dosage forms, stability s tudies, QC/QA, laboratory equipment/instruments qualification, IQ/OQ/PQ protoco ls, SOPs, cleaning validation, utilities validation, process validation, product ion equipment qualification, change control, CAPA, validation data review and an alysis, and laboratory and project management. PROFESSIONAL EXPERIENCE Staff Fellow (Compliance Officer - Scientist) April 2009- Present FDA/CDER/OC/DMPQ, Silver Spring, MD * Review and evaluate evidence and findings for a possible non-compliance or com pliance with agency regulations by applying knowledge of scientific and technica l evaluative and analytical techniques to pharmaceutical products, manufacturing process, quality system, validation, supply chain etc. * Prepare and communicate Knowledge Transfer Memo based on the review of CMC sec tion of ANDA/NDA applications with respective District Office or International C ompliance Branch for prospective GMP issues to be investigated during GMP or Pre /Post Approval Inspections of firms. * Analyze and evaluate CMC sections of NDA/ANDA applications for conformance of GMPs, critical quality attributes, critical processing parameters, stability dat a, batch release data, and method/process/cleaning validations. * Advise and provide recommendations to industry establishments, consultants, FD A investigators and reviewers on compliance issues related to pharmaceutical man ufacturing, stability, laboratory control, packaging, validation and other relat ed GMP issues. * Review and evaluate Establishment Inspection Report, FDA-483 observations/defi ciencies (OAI/VAI/NAI) and firm's responses. Prepare reports and provide authori tative advice/decision and communicate regulatory compliance reasoning with the firms for the facility approval or withhold actions. * Interact with and provide guidance to industry representatives at the agency-i ndustry meetings regarding cGMP issues related to NDA/PAS applications. * Participate as GMP expert and also as an investigation scientist on pre/post-a pproval inspections of firms. * Review and evaluate NDA applications and prepare facility review reports for d iscussion with other agency committees before PDUFA date timeline. * Plan, organize and facilitate seminars/training/symposiums as a Lead of Contin uing Technical Education for the staff members of Division of Manufacturing and Product Quality, Office of Compliance, CDER. Sr. Director of Validation/Quality 2000- 2008 Morton Grove Pharmaceuticals (Wockhardt USA), Morton Grove, IL * Provided leadership and direction to Validation / Quality department including Quality Assurance, Regulatory Compliance, Document Control, Quality Control, st ability and R & D. Member of the Executive team of Directors for risk assessmen t, problem solving, strategic planning & implementation to ensure company growth
in a positive direction. Responsible for establishing the goals and departmenta l budgets and manage activities of all the validation staff. * Managed staff of up to 8 direct and 50 indirect reports with varying levels of educational and technical experience including, but not limited, to engineers, chemists and pharmacists. * Authored IQ/OQ/PQ, process and cleaning validation protocols and final reports , validation master plans, validation SOPs and implemented Quality policy guidel ines. * Developed and successfully implemented a strategic plan for the Validation/Qua lity Systems departments to sustain departmental growth in line with the company 's objectives and FDA commitments. * Successfully guided and led the company through 4 Quality Systems GMP and 2 PA I inspections. * Aligned company with the Regulatory agency (FDA) guidelines for successful ope ration and ensured that appropriate Corrective and Preventive actions (CAPAs) are implemented to re solve the Quality & Compliance issues across the site. * Overseen all change control systems, resolve deviations (non conformances) and other issues impacting the validation, stability, production, facility and qual ity control laboratory. * Interfaced with operations, regulatory affairs, sales & marketing, R&D, techni cal services and supply chain management and ensured alignment of compliance and regulatory strategy to business strategy by building consensus among cross- fun ctional areas. Director of Validation 1998-2000 cGMP Validation, LLC., Kansas City, MO Provided consulting/contract services on site to various pharmaceutical companie s such as Bayer, Schein Pharmaceuticals, Schwarz Pharmaceuticals, Aventis, Novar tis, Northfield Labs., Cypros etc. for quality/validation projects. * Authored IQ, OQ, PQ protocols and final reports for laboratory and production equipment qualification, utilities qualification, Process validation and cleanin g validation. * Conducted, reviewed and verified analytical method validation, method transfer , validation data, and QC/QA data based on the knowledge of principles, theories and practices of analytical chemistry. * Audited and evaluated existing and new pharmaceutical products under GLP/cGMP. Research Scientist/Group Leader 1997-1998 Pharmaceutical Manufacturing Support Services ABC Laboratories, Inc., Columbia, Missouri * Conducted and reviewed/verified data for analytical method development, method verification, method transfer, method validation, stress degradation and stabil ity studies related to new and generic pharmaceutical products. * Authored equipment IQ/OQ/PQ protocols and reports, SOPs. ADDITIONAL WORK EXPERIENCE * Performed analytical method validation, method transfer, method verification, quality control analysis of raw material and finished products. Directed and man aged laboratory staff and activities. * Designed and developed basic and novel chemical manufacturing processes, impro ved existing processes for Active Pharmaceutical Ingredients, pharmaceutical int ermediate chemicals, fine chemicals, perfumery chemicals. * Guided scale up operations and technology transfer from laboratory and pilot p lant to large scale manufacturing. * Taught Organic/Pharmaceutical Chemistry to Undergraduate Students in India, Ca
nada and USA. EDUCATION Ph.D., Organic Chemistry, M. S. University of Baroda, Baroda, India M.Sc., Organic Chemistry, M. S. University of Baroda, Baroda, India Diploma in German Language, Goethe Institute/M. S. University of Baroda, Baroda, India CITIZENSHIP: USA
TRAINING: Successfully completed Pre-Approval Inspections Training, Basic Drug S chool and Level III Drug Investigators Training conducted by ORAU. REFERENCE: Provided upon request
in a positive direction. Responsible for establishing the goals and departmenta l budgets and manage activities of all the validation staff. * Managed staff of up to 8 direct and 50 indirect reports with varying levels of educational and technical experience including, but not limited, to engineers, chemists and pharmacists. * Authored IQ/OQ/PQ, process and cleaning validation protocols and final reports , validation master plans, validation SOPs and implemented Quality policy guidel ines. * Developed and successfully implemented a strategic plan for the Validation/Qua lity Systems departments to sustain departmental growth in line with the company 's objectives and FDA commitments. * Successfully guided and led the company through 4 Quality Systems GMP and 2 PA I inspections. * Aligned company with the Regulatory agency (FDA) guidelines for successful ope ration and ensured that appropriate Corrective and Preventive actions (CAPAs) are implemented to re solve the Quality & Compliance issues across the site. * Overseen all change control systems, resolve deviations (non conformances) and other issues impacting the validation, stability, production, facility and qual ity control laboratory. * Interfaced with operations, regulatory affairs, sales & marketing, R&D, techni cal services and supply chain management and ensured alignment of compliance and regulatory strategy to business strategy by building consensus among cross- fun ctional areas. Director of Validation 1998-2000 cGMP Validation, LLC., Kansas City, MO Provided consulting/contract services on site to various pharmaceutical companie s such as Bayer, Schein Pharmaceuticals, Schwarz Pharmaceuticals, Aventis, Novar tis, Northfield Labs., Cypros etc. for quality/validation projects. * Authored IQ, OQ, PQ protocols and final reports for laboratory and production equipment qualification, utilities qualification, Process validation and cleanin g validation. * Conducted, reviewed and verified analytical method validation, method transfer , validation data, and QC/QA data based on the knowledge of principles, theories and practices of analytical chemistry. * Audited and evaluated existing and new pharmaceutical products under GLP/cGMP. Research Scientist/Group Leader 1997-1998 Pharmaceutical Manufacturing Support Services ABC Laboratories, Inc., Columbia, Missouri * Conducted and reviewed/verified data for analytical method development, method verification, method transfer, method validation, stress degradation and stabil ity studies related to new and generic pharmaceutical products. * Authored equipment IQ/OQ/PQ protocols and reports, SOPs. ADDITIONAL WORK EXPERIENCE * Performed analytical method validation, method transfer, method verification, quality control analysis of raw material and finished products. Directed and man aged laboratory staff and activities. * Designed and developed basic and novel chemical manufacturing processes, impro ved existing processes for Active Pharmaceutical Ingredients, pharmaceutical int ermediate chemicals, fine chemicals, perfumery chemicals. * Guided scale up operations and technology transfer from laboratory and pilot p lant to large scale manufacturing. * Taught Organic/Pharmaceutical Chemistry to Undergraduate Students in India, Ca
nada and USA. EDUCATION Ph.D., Organic Chemistry, M. S. University of Baroda, Baroda, India M.Sc., Organic Chemistry, M. S. University of Baroda, Baroda, India Diploma in German Language, Goethe Institute/M. S. University of Baroda, Baroda, India CITIZENSHIP: USA
TRAINING: Successfully completed Pre-Approval Inspections Training, Basic Drug S chool and Level III Drug Investigators Training conducted by ORAU. REFERENCE: Provided upon request
