On-Demand Webinar

Stepwise Implementation of a Clinical QMS

Science and research-driven activities require a high degree of flexibility and demand fast reviews of development stages – at times, even reconsideration of the development program or project termination altogether.

For biotech and pharma companies, research and development (R&D) activities may occur on a singular or multiple development project(s). Such projects can be at distinct stages in development, jump back and forth between stages, or enter and leave the organization at different stages. This is a very dynamic – and at times, circular – process requiring a high degree of flexibility. An organization should turn to a systematic approach of applying instructions and a structured framework of descriptions which offer guidance to the organization and align towards harmonized execution of processes.

Join us to explore the latest quality management system (QMS) strategies for advancing R&D activities across all phases of the clinical research lifecycle from Steffen Engel, Ph.D., Managing Expert, Advarra Quality Center of Excellence. The webinar will dive into current QMS challenges and recommend strategies to advance successful QMS programs cross-functionally across your enterprise.

Learning Objectives:

  • Learn successful strategies for a stepwise implementation of a clinical QMS, tailored to state of company and development
  • Gain an in-depth understanding of leveraging risk-based methodology
  • Understand the process for identifying critical quality indicators and tracking methods

Presented By

SteffenEngel.png

Steffen Engel

Ph.D., MBA

Managing Expert, Advarra Quality Center of Excellence
Former Executive Director Analytical Development, West-Ward Pharmaceuticals

Empty Image Placeholder

n/a

n/a

n/a
n/a

Empty Image Placeholder

n/a

n/a

n/a
n/a

Empty Image Placeholder

n/a

n/a

n/a
n/a

 

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, Regulatory Program Supervisor, VP Regulatory Affairs, and Regulatory Scientists.

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.

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: April 21, 2022
Time: 1 pm ET | 10 am PT
Duration: 1 hour

Register Now