DATE/TIME
September 19, 08:30 – 09:00 PM EST
TITLE
Inspection Intelligence: What the FDA Is Really Looking for Now
SPEAKER
Linda Evans O’Connor
Vice President
Lachman Consultants
ABSTRACT
In this session, Linda Evans O’Connor, Vice President at Lachman Consultants, will share insights into current FDA inspection trends and priorities, offering practical guidance for navigating evolving regulatory expectations. Drawing on her extensive experience in quality management and compliance across multiple dosage forms, she will provide strategies to strengthen inspection readiness and ensure ongoing compliance in a rapidly changing regulatory landscape.
BIO
As Vice President at Lachman Consultants, Linda Evans O’Connor, MBA, oversees and manages critical operational activities that include project oversight/management, work planning and workflow analysis, and quality assurance. Ms. O’Connor has a deep understanding of the pharmaceutical industry and delivers thought leadership on client projects. She maintains current industry/leading practices knowledge and understanding to further broaden her comprehensive knowledge of the pharmaceutical industry, including the ability to understand and interpret current/envisioned regulatory and compliance processes and procedures.
Ms. O’Connor has distinguished herself as an accomplished quality professional with extensive, progressive experience and achievements in quality management, project management, and leadership of diverse, global and cross-functional teams. Her expertise and insights guide Lachman Consultants’ clients in quality management systems, regulatory inspection preparation, and GxP audits. She is experienced in solid oral, semi-solid (creams and ointments), parenterals, and liquid dosage forms.
Ms. O’Connor is a thoughtful and skilled speaker, most often sought after to address professional groups and organizations on the topics of Managing Global Quality, Quality Risk Management, and Preparing for FDA Inspections. Online, Ms. O’Connor contributes her insights, expertise and professional acumen to Lachman Consultants’ ongoing webinar series which focuses on FDA-related topics.
Ms. O’Connor’s professional memberships and affiliations include the International Society for Pharmaceutical Engineers (ISPE) and Parenteral Drug Association (PDA).
