Satyam has conducted 350+ audits for GMP, GLP, GCP, GPvP and GDP regulatory compliance in different countries. He has lead the preparation for and / or hosted regulatory inspections by different regulatory authorities including CDSCO (India), US FDA, EMA, PMDA, ANVISA, OECD GLP Monitoring Authorities, etc. and in different countries, e.g. India, USA, European countries, Japan, Russia, South Africa, Brazil, Mexico, China, Korea, Taiwan, etc.

Satyam joined the R & D QA department of Torrent Pharmaceuticals in 1998 and worked to establish the quality systems for GXP compliance in different functions. In 2001, Satyam got the additional responsibility to support the Corporate QA and Regulatory Affairs team for the development of the products for the regulated markets. This brought the responsibilities such as interpreting the EU product registration regulations, guiding the development teams for compliance and reviewing the regulatory submissions. The combined GXP compliance and regulatory affairs responsibilities for product development provided a deeper insight into GXP regulations.

Satyam joined Quintiles QA in 2004 and worked for the quality of clinical development services for GCP and regulatory compliance. In 2010, Satyam moved in to a global QA role with the responsibility of delivering QA services to the clients across the world. The main priorities of this role were to lead the compliance of the clinical programs along with client QA, to negotiate audit strategies and quality agreements and to support the account management for business strategy and operational collaboration.

Surabhi has about 18 years of experience in GMP compliance and regulatory affairs in the Indian pharmaceutical industry. With her breadth of experience – APIs, formulations and dietary supplements –she can manage a variety of GMP audits, training and dossier/DMF preparation for submission to different regulatory authorities.

Over the years, Surabhi has worked on a large number of projects and has managed regulatory inspections by several regulatory authorities such as US FDA, ANVISA, and customer audits by many large multinational pharma companies.

Surabhi has experience of handling regulatory affairs of a wide range of product categories like APIs, formulations and dietary supplements. She has hands on experience in preparing and reviewing DMFs, dossiers as per international requirements such as EU, US and ACTD. Her in-depth understanding of stability testing, method validations, process validations as per ICH guidelines, QMS and ISO systems helps her in handling queries during review and approval of dossiers and DMFs.

Sash Modhia has over 12 years of multinational work experience with companies like PAREXEL, GE and Philips specializing in QMS, FDA inspections and ISO certification audits for the medical devices and pharmaceutical industry. Sash started as a Paradigm Designer for the Neuro-Imaging Lab at The Southwestern Medical Center, Dallas USA, where he conceived and programmed computer adaptive tests to measure brain response to decision making tasks in cocaine addicts. He moved onto working for one of the top 5 CROs (contract research organization) in world, PAREXEL, Boston USA, where he was involved in analysis of imaging data from Phase II and Phase III clinical research. In 2007 Sash joined GE, Maryland USA as a Quality Engineer and for next seven years was engaged in design and development as well as manufacturing. It was here that he got hands-on experience in V&V, Reliability testing, 510k submission, Preventive Maintenance, Supplier Management & Qualification, Defect Management, CAPA, ISO inspections and FDA inspections, and design ownership transfer. He was appointed the manager of internal audit program.

He is currently involved on projects such as managing QMS integration post acquisition of new product lines.

Michael Ramcharan has over 25 years of experience in Quality Assurance having worked with multinational Pharmaceutical and Clinical Research Organisations since 1990. His auditing experience has involved conducting a wide variety of audits in GPVP, GCP and GCLP, globally. He has also hosted and supported various Regulatory Authority Inspections (eg; MHRA, EMA, Local EU) in the GCP and GPV space.

Michael’s audit experience has also extended to successfully designing , implementing and conducting Remote audits in the GPVP arena which has allowed companies to maintain strong oversight of their Local Operating Companies and Business Partners in countries where travel restrictions do not allow for on-site audit visits. He has also assisted companies in managing their Pharmacovigilance QA audit programs adopting a risk based approach to help identify and prioritise audits.

Michael has also been involved in the Training and Mentoring of auditors, providing bespoke training catered specifically to an individual’s development needs, and his varied experience has proved very valuable in this area.