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.”
Join Marie-Christine Poisson, Managing Expert, and Anthea Dransfield, Managing Director at Advarra Quality Center of Excellence on Thursday, October 6th at 1:00 pm ET to 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.
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.
If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education requirements.
Certificate of Attendance
After watching this webinar in its entirety and completing the webinar survey, you will receive a certificate of attendance. This certificate will be emailed to you within one business day of watching the webinar. Please note that if your organization has other staff members who wish to get a certificate of attendance, each person must register, watch the webinar in its entirety, and complete the webinar survey. Visit our Webinar Help page for more information on certificates of attendance.
DATE: October 6, 2022
Time: 1 pm ET | 10 am PT
Duration: 1 hour