Dr Dholakia is a Pharmaceutical professional with progressive and diversified experience in FD&C Act, GMP regulations, compliance policies and procedures, FDA principles and practices, facility inspections, audits, Pre-approval inspection preparations, Form 483 and warning letter response review and evaluation, third party audits, and regulatory compliance. Experience with bulk pharmaceuticals (API), liquid oral, solid oral, nasal, and topical dosage forms, stability studies, quality control and quality assurance, laboratory equipment/instruments qualification, standard operating procedures, cleaning validation, process validation, production equipment qualification, change control, corrective & preventive actions, manufacturing process, data integrity, data review and analysis, OOS/deviation investigations and project management.