Day One

1	Examine the Approval Process and Pre-Approval Inspection Program Presents an introduction to FDA regulations, requirements, and the review process Discuss the types of inspections: Routine vs. Cause. Determine compliance that needs to be addressed

Session 2

Identify the FDA’s expectations for Drug Establishments

Development and manufacturing procedures

Quality Assurance standards

Employee compliance, training and practices

Accurate reports, records, and communications

3	Analyze Major Elements Covered During the PAI Review of organizational procedures Assess facility standards and functions Analyze data and records Evaluate policies and procedures of employees and managers Look at company training procedures

Session 4

Overcome Common Documentation Obstacles

Best documentation practices

Document evidence of validation

Storage and security issues

5	Establish and Maintain Self- Audit Programs to Ensure Preparedness Implement a risk management structure Establish written procedures to assure compliance Communicate regulatory standards throughout your organization Maintain accurate records of meetings, reports and studies

Session

Day One Training Concludes

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