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Annex 1

New GMP Annex 1: How to Stay Ahead in Sterile Manufacturing

Stay ahead with the new EU GMP Annex 1—discover key updates on QRM, CCS, and cleanroom monitoring for compliance and product safety.

GxP Compliance

Embracing Paperless Validation in a Fast-Evolving Life Sciences Industry

Embrace paperless validation to streamline workflows, enhance compliance, and reduce costs while meeting evolving regulatory standards in life.

Commissioning, Qualification and Validation (CQV)

Why Equipment Qualification & Validation are Non-Negotiable in Life Sciences

Equipment Qualification & Validation: essential for quality, safety, and compliance in Life Sciences manufacturing

Artificial Intelligence

Why Life Sciences Needs Responsible AI use with Human Validation

Learn how AI validation, ethics, and oversight ensure safe, effective AI in life sciences under the EU AI Act.

Regulatory Affairs

IVDR: What Does It Mean for Manufacturers of In Vitro Diagnostic Devices?

The transition to IVDR introduces new challenges for IVD manufacturers, with stricter requirements and revised timelines to ensure compliance

Pharmacovigilance

EMA's 2025 Benefit-Risk Guidelines: Impact on Veterinary Medicine

Discover what the EMA’s updated benefit-risk guidelines for veterinary medicine mean in 2025 and how they impact manufacturers, veterinarians, and.

Clinical Research

Why Small Pharma Companies Rely on CROs and What They Expect

Small pharma companies rely on CROs for expertise, cost-effectiveness, flexibility, and strong communication in clinical trials.

IT Operations

The Challenges of Operating System Obsolescence in the Pharmaceutical Industry

Challenges of OS obsolescence in pharma: cybersecurity risks, compliance issues, and the need to migrate from Windows 10 to ensure security and.

Pharmacovigilance

Post-Brexit UK Pharmacovigilance for European Veterinary Businesses

Key post-Brexit UK regulations for European veterinary businesses: compliance, registration, and pharmacovigilance

CSV & Data Integrity

How Equipment Connectivity and Data Collection Are Revolutionizing the Pharmaceutical Industry

The pharmaceutical industry uses data, IoT, and AI/ML to boost efficiency and accuracy. For this reason, maintaining quality and security is crucial.