Manufacturing, Supply Chain, Distribution, Master Planning
Many companies face growing challenges in response to an increasingly complex regulatory environment. They must address various requirements that span geographies, business activities, processes, and industries. Failure to comply with these regulatory requirements would be costly for a company and can result in fines, remediation costs, and reputational damage. In this session, you will learn:
• How to approach GMP in Dynamics AX / 365
• Benefits of implementing GMP for companies
• Global agency requirements for computer systems in a “GxP” environment
AXSource Infotech Inc.
Navneet Sekhon holds an Honours Bachelor of Science from the University of Toronto and Finance Management training from Richard Ivey School of Business in London.
She is the owner of AxSource Consulting, an established life science company in Canada. Her firm offers outstanding expertise in government liaison with FDA, Health Canada, EMA, MHRA and TGA in order to support the global launch of therapeutic products and support approval of manufacturing facilities.
She is an accomplished executive with over 30 years of international experience leading results-driven project management, clinical, regulatory affairs, quality/compliance and post market surveillance initiatives across diverse industries including Medical Devices, Biologics, Pharmaceuticals, Natural Health and other regulated products.
As a strategic player with expertise in regulatory affairs, pre-clinical (GLP), clinical (GCP), manufacturing (GMP), distribution (GDP), and pharmacovigilance compliance programs including privacy, anti-trust laws, certified quality auditing and process validation. Navneet is often required to provide expert opinion in class action lawsuits.
She has been involved with major computer system validation projects such as SAP R3, JD Edwards, Baan, QAD, LIMS, PCS, and Microsoft Dynamics Suite of products in accordance with FDA Process Validation, GAMP5 & 21 CFR Part 11 requirements. Navneet has been a solutions architect in the development of software for Product Complaint Handling Systems, automated instructional training program and AXOQCS™- a Quality Systems Management solution integrated with Microsoft Dynamics AX & D365 for Pharmaceutical and related life sciences companies.
Navneet has held positions of Chair for the Canadian Association for Professionals in Regulatory Affairs and Medical Device Regulatory Steering Committees. She currently serves on the Executive Advisory Committee of CAPRA.
Tuesday, April 24
11:30 AM – 12:30 PM