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

Day Two

7	Quality Assurance in the Laboratory • FDA inspection approaches • Using statistics to justify test results • Meet regulations for personal training and equipment validation

Session 8

Managing Vendors and Suppliers

Exercise: Analyze Case Studies • The importance of vendor and supplier evaluation • Identify quality resources for all parts of the process • Key elements of an effective supplier agreement • Execute vendor audits

9	The Best Documentation Practices Exercise: Sample SOPs and Other Documentation Determining what requires documentation Maintaining control and preventing validation “red flags” Create SOPs, protocols, Master Validation Plans (MVPs) and other documentation

Session 10

Dealing with Non-Conformances, Deviations & Complaints

Exercise: Deviations and Investigations

Study Corrective and Preventative Action (CAPA)

Perform OOS investigations

Recognize change control program necessities and common associated errors

11	Reviewing Batch Records Conducting batch identification procedures Assessment of packaging requirements Criteria for determining the release or reject of APIs

Session 12

Examine and Evaluate: Statistics and Control Charts

Exercise: Control Charts • QSR Section 820.250 Statistical Techniques Requirements • Reliability vs. Variability • Statistical Tools • Continued maintenance of standards and traceability

13	Assess Current Regulatory Activity Exercise: Case Studies from an FDA Inspector’s Point of View Examine quality-related 483s and Warning Letters Analyze current 483 trigger points Prepare for FDA audit and execute the necessary process steps

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