Tracking an Effective QMS: From Discovery Through Post Study
As sponsors journey through clinical phases during investigational drug product development, enterprise-wide preparation goes into submitting the investigational new drug (IND) application. Did you know this is when an organization can initiate the fourth phase of the quality management system (QMS)?
Is your QMS a one-size-fits-all? A phased QMS approach offers the flexibility of stage-appropriate implementation to account for dynamic processes as your drug development progresses. In a rapidly evolving regulatory landscape, maintaining GxP compliance in every phase of drug development is critical.
Steffen Engel, Managing Expert, and Anthea Dransfield, Managing Director at Advarra Consulting explore real world experiences of implementing QMS strategies at biotech and pharma companies in various clinical research stages.
- Understand the benefits of a risk-based approach to validation
- Outline the five critical components of a connected quality platform
- Effectively adapt to market and regulatory changes
- Understand the process for identifying critical quality indicators and tracking methods
Managing Expert, Consulting
Managing Director, Consulting
Who should watch?
This content applies to sponsors and CROs and growing biopharma and pharma companies.
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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DATE: June 17, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour