Growth Mode: Developing a Fit-for-Purpose QMS Model
Growth mode – is an oft-repeated phrase used by emerging biotech and biopharma companies to describe their fast-evolving research and development (R&D) operations status. In life sciences, R&D activities can be very dynamic – and at times, a circular process requiring a high degree of flexibility. Using a systematic approach of applying instructions and a structured framework of descriptions that offer guidance to the organization and also align towards harmonized execution of processes may seem insurmountable and cost-prohibitive to companies in “growth mode.”
Marie-Christine Poisson, Managing Expert, and Anthea Dransfield, Managing Director at Advarra Quality Center of Excellence explore the latest quality management system (QMS) strategies to advance R&D activities specifically focused on companies in growth mode.
Learn successful strategies for a stepwise implementation of a clinical QMS, tailored to companies in growth mode
Gain an in-depth understanding of leveraging risk-based methodologies
Understand the process for identifying critical quality indicators and tracking methods
Who should watch?
This content applies to sponsors and CROs, growing biopharma and pharma companies - anyone involved in Quality, Procurement Director, Vendor Management, Outsourcing Manager, Strategic Sourcing, Proposal Manager, VP/Director of Quality, Manager of Quality Data Manager, IT Manager research, Pharmacovigilance, Safety monitoring, drug safety, Environmental Health and Safety Officer, Biosafety Officer, Laboratory Safety Officer Clinical Development Manager, Clinical Development Lead, Director of Regulatory Affairs, Clinical Trials Regulatory, Clinical Research, and Regulatory.
Attendance at this session has been approved for 1.00 contact hour of research specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations.
The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1 hour of CE credit.
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Certificate of Attendance
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DATE: June 17, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour