Is your pharmaceutical quality system receiving the scrutiny it needs?
About this Webinar
Keeping pace with the evolving regulatory environment means that pharmaceutical and biotech organisations must maintain a quality system that is resilient during close scrutiny from authorities such as the MHRA, EMA and FDA.
In this UK focused session, delivered in collaboration with our partner Scilife, Angel Buendía, Pharmaceutical Quality and CMC Expert and Consultant, together with Christopher Homan, Rephine consultant, will share practical guidance tailored to growing and mid sized organisations. The session will explore current inspection behaviours, common compliance challenges and actionable ways to strengthen inspection readiness while keeping quality processes simple and effective.
The session will cover the following topics
- UK and EU regulatory expectations and how they shape your quality system
- Essential PQS considerations for expanding pharmaceutical and biotech teams
- Current inspection trends from the MHRA, FDA and EMA, including data integrity focus points
- Practical methods to maintain inspection readiness
- Best practices for managing responses and preventing post inspection escalation
Watch the full webinar and strengthen your inspection readiness today
Agenda
06:15
PQS Requirements and Challenges
25:10
Compliance Challenges and Data Integrity
44:25
Inspection Readiness
58:50
Managing Responses to Agencies
59:55
Q&A
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