Associate Director, Safety, Regulatory and Quality Solutions IQVIA
Description: Labeling is quickly becoming the forefront of data-centric processing in life science operations. As a result, a brighter spotlight is shining on the need to avoid noncompliance by optimizing labeling operations through advanced analysis and automation. Additionally, regulatory labeling requirements are continuously becoming stricter and more difficult to manage from both an intelligence and operational perspective. Companies and their regulatory teams are struggling to find a balance between the need to amend business processes and adopt new technologies in a way that is flexible and scalable while simultaneously minimizing cost.
Despite the challenges of balancing cost minimization with new technology adoption and process optimization, companies still face an immediate need to remain compliant in a challenging document-centric labeling environment. Companies desperately need to: - Implement centralized, foundational label information management technology to manage orchestration and tracking of docu-centric labeling activities. - Expand solutions to meet new and tightening data-centric requirements, which require componentized document management technology, while ensuring minimal negative impact, through cost reduction strategies and workflow implementation optimization. - Identify opportunities to allow existing resources, systems and documents to provide added value to labeling operations as opposed to leveraging menial and repetitive manual tasks to ensure compliance.
Learning Objectives:
Upon completion, participant will be able to understand information consolidation for labeling (how to identify changes, capture relevant information as well as assess responses and decisions with a single platform).
Upon completion, participant will be able to understand process orchestration for labeling (how to optimally define and execute steps in the labeling process from change control to implementation).
Upon completion, participant will be able to understand intelligent automation for labeling (how to improve information consolidation and process orchestration with scalable, purpose-built for the life science industry, technology solutions).