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

Onsite Pharma FDA Inspections During COVID-19 Respect State Restrictions

March 3, 2021
Redica Systems
No items found.
Conference Spotlight

Desk Inspections, Missed Action Dates Take Place of FDA In-Person Site Visits

February 25, 2021
Redica Systems
No items found.
Conference Spotlight

FDA Chooses Not to Perform Virtual Inspections in Contrast with Non-U.S. Agencies

February 18, 2021
Redica Systems
No items found.
Conference Spotlight

Impact of the EU MDR on Combination Product Sale and Registration in the EU

February 11, 2021
Redica Systems
No items found.
Conference Spotlight

Case Study of Contaminated WFI in China

February 3, 2021
Jerry Chapman
China
GMP
pharmaceutical water
Quality
Small Pharma
Conference Spotlight

EU Animal Health Legislation Aims to Reduce Industry Burden

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

Russian Inspectorate Weighs in on Remote Audits and International Harmonization

January 20, 2021
Redica Systems
No items found.
Conference Spotlight

FDA Combination Products Policy and Guidance Changes

January 14, 2021
Redica Systems
No items found.
Conference Spotlight

FDA OMQ Regulatory Actions Increase Dramatically in FY2020

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

Latest Chinese Pharmacopoeia Includes Updated Chapters in Key Areas

December 17, 2020
Redica Systems
No items found.
Conference Spotlight

FDA’s Vision for the Future of Biomanufacturing

December 16, 2020
Redica Systems
No items found.
Conference Spotlight

89 Products Filed as NDAs Now BLAs Under Regulation Change

December 16, 2020
Redica Systems
No items found.
Conference Spotlight

Overcoming the Quality Challenges of a CAR-T Cell Product: One Company’s Experience

December 10, 2020
Redica Systems
No items found.
Conference Spotlight

Impact of Brexit on UK & Northern Ireland Medical Device Regulations

December 9, 2020
Redica Systems
No items found.
Conference Spotlight

FDA Cracks Down on Unapproved HCT Products

December 3, 2020
Redica Systems
No items found.
Conference Spotlight

Russian Drug Regulator, MHRA, and FDA Processes for Evaluating & Escalating Drug GMP Inspection Findings

November 30, 2020
Redica Systems
No items found.
Conference Spotlight

CBER Director Wilson Bryan On How To Cut CGT Product Approval Times In Half

November 18, 2020
Redica Systems
No items found.
Conference Spotlight

What a Scuba Diving Incident Can Teach Pharma About Quality Systems

August 19, 2020
Redica Systems
No items found.

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