Presented by:Khaled MoussallyExecutive Vice President, Corporate Development & OperationsCompliance GroupSaradha RamamoorthyHead, Strategic Consulting – IndiaCompliance Group Inc.David .P.DelucaDirector, Strategic ConsultingCompliance Group Inc.Ken ShitamotoMS, Sr. Director ITGilead SciencesSenthil GurumoorthiPrincipal, Global Lead-Healthcare & Life Sciences, Security & ComplianceAmazon Web ServicesUnderstand Agile vs. Waterfall Methodologies: Explore the key differences between Agile and Waterfall approaches, and learn how each impacts […]
Presented by: Diego Amesquita, Director, Business Transformation, Main & MissionThe rapid adoption of Artificial Intelligence (AI) in the Life Sciences industry is transforming how organizations operate, think, and govern. As AI reshapes the landscape, it is imperative to implement robust Organizational Change Management (OCM) strategies to ensure a smooth and successful transition.In this webinar, Driving […]
Presented by: Philip Jarvis, Director Integrated C&Q and Paperless Strategy, Veqtor SolutionsDiscussion on how emerging technology such as AI/and machine learning has the potential to change the world of validation , and help achieve validation 4.0 principles . How do we create a digital validation ecosystem ,create data integrity by design, and harness digital validation […]
Presented by: Ritam Priya, Consultant, MDRQ ConsultingManufacturers (including software developers) need to gather objective evidence of performance, safety and efficacy to support both their premarket authorization/registration in different markets and postmarket changes. Regulatory requirements are defined by different regulators for product compliance and different committees like ISO, AAMI and IEC that develop standards to help […]
Presented by: Cody Beaumont, Associate Director, Quality Compliance and Regulatory, CAIAnnex 1 and a Contamination Control Strategy are critical aspects of pharmaceutical manufacturing, focusing on maintaining quality, safety, and compliance as is expected in a regulatory setting. Annex 1 of the European Union’s Good Manufacturing Practice (GMP) serves as a guideline and cornerstone for sterile […]
