FDA inspections continue to identify recurring cGMP deficiencies across pharmaceutical, medical device, and combination product manufacturers. These deficiencies often relate to foundational quality system elements such as documentation practices, CAPA effectiveness, data integrity, electronic records, and risk-based compliance controls.

This webinar provides an overview of major cGMP issues currently drawing FDA attention, based on inspection trends, enforcement activity, and regulatory expectations. Attendees will gain insight into how FDA evaluates compliance during inspections and why certain deficiencies repeatedly result in observations, Form 483s, or Warning Letters.

The session is designed to help professionals understand where FDA scrutiny is focused today and how gaps in cGMP understanding or execution can lead to increased regulatory risk.

After this webinar attendees will be able to answer

• What cGMP issues are most frequently cited by the U.S. FDA during inspections
• How FDA inspection observations and Form 483 findings are commonly triggered
• What FDA means by a risk-based approach to cGMP compliance
• Which quality system weaknesses most often lead to corrective actions or follow-up scrutiny
• How areas such as CAPA, documentation, data integrity, and electronic records factor into FDA concerns
• Why misunderstanding current FDA enforcement trends can increase compliance risk

This webinar benefits the following agencies

• Pharmaceutical manufacturers
• Medical device and combination product manufacturers
• Quality assurance and quality management teams
• Regulatory affairs and compliance departments
• Organizations subject to FDA cGMP inspections

Who should attend?

• Quality Assurance and Quality Control professionals
• Regulatory Affairs and Compliance personnel
• Manufacturing and Operations management
• Engineering and Production teams
• IT and Data Integrity professionals
• Consultants supporting FDA-regulated organizations