On-Demand Webinar

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.

Learning objectives:

  • 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

Presented By


Steffen Engel

Managing Expert, Consulting


Anthea Dransfield

Managing Director, Consulting

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Who should watch?

This content applies to sponsors and CROs and growing biopharma and pharma companies.

CE Credits

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.

This event may qualify for continuing education (CE) credits. Please check with your professional organization(s) to determine whether the event meets their CE eligibility 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: June 17, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour

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