Recall Readiness

Attend a webinar on recall readiness for health authorities to avoid warning letters, reduced credibility, fines, and criminal prosecution, covering core requirements, recall playbook concepts, stakeholder communications, and best practices.
  • Tuesday
  • June
  • 17
  • 2025
10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes
IMG Patterson Shafer
Webinar Id: 61283
Live
Session
$119.00
Single Attendee
$249.00
Group Attendees
Recorded
Session
$159.00
Single Attendee
$359.00
Group Attendees
Combo
Live+Recorded
$249.00
Single Attendee
$549.00
Group Attendees

Overview:

Recall readiness is a key requirement for pharma and medical device manufacturers. Health authorities expect that manufacturers know where their products are in use and how to reach the patients and providers that use them. In the event of an issue, manufacturers are expected to be able to effectively communicate with consignees and, if required, recall and document receipt of all products in the field.

Why you should Attend:

Health Authorities are very focused on recall readiness. Failure to conduct an effective field action can result in warning letters, reduced credibility with a regulatory authority, fine, and even criminal prosecution. 

On average, 3,692 drug and medical device products are recalled every year.

A recall can cost ~$10-20 million. In addition, companies can suffer irreversible reputation damage.  

The webinar will address the core requirements for an effective recall and introduce the concept of a recall playbook, covering topics such as maintaining accurate consignee contact information, effective stakeholder communications, health authority interactions, product status transparency, as well as best practices and lessons learned.

Areas Covered in the Session:

  • Health authority regulations and expectations
  • Anatomy of a recall - step-by-step process
  • Best practices and lessons learned

Who Will Benefit:

  • Quality
  • Supply Chain
  • Regulatory Affairs
  • Legal
  • Compliance

Speaker Profile

Patterson Shafer has over 30 years of experience solving complex global challenges and helping clients achieve their strategic and operational objectives in the areas of quality and compliance, regulatory affairs and operations, clinical, safety and surveillance, manufacturing, supply chain, medical affairs and commercial.

Pat has extensive knowledge and experience with post-market surveillance and field actions, including recall readiness. His work in that area includes identifying technology solutions to detect quality and safety signals, reengineered pharmacovigilance, complaint, CAPA and field action (recall) processes, and redesigned medical review organizations to advance compliance, safety, and operational efficiency. He has written recall best practices playbooks, published articles, and presented at multiple conferences on the subject, in addition to overseeing multiple recalls for medical device companies.