Navigating The Capa Conundrum: Problem Statements and More
The Problem with Problem StatementsThe Bias TrapThe FDA's Perspective of CAPAChallenges Faced by CompaniesMoving Forward In the world of FDA-regulated quality management, CAPA (Corrective and
GxP Best Practices Part 2: Early Stage Tips for Data Integrity
In Teresa Gorecki's second session of Executive-level GxP training, the two reviewed Regulatory Compliance Fundamentals for Early-Stage Development, emphasizing the importance of data integrity. Evolving
Data Integrity: The Foundation of Medical Product Manufacturing Compliance
The FDA and other global regulators rely on data reviews during inspections to determine whether a pharmaceutical or medical device manufacturer operates within regulatory requirements and expectations. The credibility
John (Jack) Garvey Has Been Selected by Our Partners QbDVision to Join Their Newly Formed Board of Advisors
We are excited to announce that our CEO, Jack Garvey, has been selected by our partners QbDVision to join their newly formed board of advisors!
Risk Management and Data Integrity: Focusing on the Critical
The FDA has long taken a risk-based approach to manufacturer GMP compliance expectations and enforcement actions, as well as requiring pharmaceutical and medical device manufacturers