Conference Spotlight

Key takeaways, industry discussions, and insights from major regulatory conferences.

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Alison Sathe
Anders Vinther
Barbara W. Unger
Jackie Torfin
Jerry Chapman
Jon Falker
Katie Terry
Mark Agostino
Rebecca Stauffer
Redica Systems
Roger Angarita
Sarah Boynton
Scott Sherrill
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Conference Spotlight

ICH Q9: Quality Risk Management Revision Focuses on Six Topic Areas

February 3, 2022
Redica Systems
No items found.
Conference Spotlight

What is the Best Way to Prepare for an FDA inspection?

January 20, 2022
Redica Systems
No items found.
Conference Spotlight

UDI Compliance for Medical Devices: Part I

January 11, 2022
Redica Systems
No items found.
Conference Spotlight

FDA on Cross-Contamination, Sustainable Compliance, and Contract Ops

January 6, 2022
Redica Systems
No items found.
Conference Spotlight

Quality Culture Assessments and Records Request Responses

December 16, 2021
Redica Systems
No items found.
Conference Spotlight

FDA Regulators Address Data Integrity and Lab Audit Trails

December 9, 2021
Redica Systems
No items found.
Conference Spotlight

Postmarket Medical Device Surveillance at CDRH: Part II

October 28, 2021
Redica Systems
No items found.
Conference Spotlight

Postmarket Medical Device Surveillance at CDRH: Part I

October 21, 2021
Redica Systems
No items found.
Conference Spotlight

Best Practices for Responding to a Medical Device FDA 483

October 7, 2021
Redica Systems
No items found.
Conference Spotlight

EU MDR and Economic Operators for Medical Devices

September 30, 2021
Redica Systems
No items found.
Conference Spotlight

Process Capability in Focus in FDA Device Inspections

September 16, 2021
Redica Systems
No items found.
Conference Spotlight

Many Device Cleaning Validation Programs Need Work, FDA Investigator Says

September 2, 2021
Redica Systems
No items found.
Conference Spotlight

Navigating a Regulatory Path to Market Through EU MDR Article 117

August 19, 2021
Redica Systems
No items found.
Conference Spotlight

ORA Targets CAPA Effectiveness Check Deficiencies

August 12, 2021
Redica Systems
No items found.
Conference Spotlight

Pharma Must Develop Quality Leaders: Here is One Approach

August 5, 2021
Redica Systems
No items found.
Conference Spotlight

UK’s MHRA Reinventing Itself as Sovereign Regulator

July 22, 2021
Redica Systems
No items found.
Conference Spotlight

How to Assess and Advance a Pharma Company’s Quality Maturity

July 15, 2021
Redica Systems
No items found.
Conference Spotlight

Do FDA Policies Discourage Pharma from Deploying New Technologies?

July 8, 2021
Redica Systems
No items found.

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