Managing FDA GXP Inspections CONTENT Package

This 200+ slide PDF PowerPoint training presentation is a complete training document on reviewing FDA’s inspectional process to executing an FDA GXP inspection from planning through post GXP inspections. Also included in this package the comprehensive SOP" Management of Regulatory Agency Inspections"

➢1.Managing FDA GXP Inspections PowerPoint Presentation

To View Complimentary Excerpt Click Here

➢2. Management of Regulatory Agency inspections SOP

To View Complimentary Excerpt Click Here

1.Managing FDA GXP Inspections PowerPoint Training Presentation

To View Complimentary Excerpt Click Here

This 200+ slide PDF PowerPoint training presentation is a complete training document on reviewing FDA’s inspectional process to executing an FDA GXP inspection from planning through post GXP inspections.

This ready made presentation will save you time and money related to developing and presenting FDA inspection training to colleagues and coworkers.

➢ Origin of FDA Regulatory Inspections

FDA’s authority to inspect

Scope of regulatory inspections

FDA – geographic locations

How and why FDA regulates

➢FDA Inspectional Process

How inspections are planned and triggered

Inspection planning by FDA

GCP, GLP, GMP inspection process

Overview of FDA enforcement actions

Tools FDA uses to conduct inspections

FDA forms used

FD483s, NAI, VAI, OAI

FD481 (EIR)

Field district’s final compliance decision

➢FDA Enforcement Action Beyond FD483s – i.e., Warning Letters (with examples)

Other FDA enforcement actions

Types of judicial enforcement

Seizure, Injunction, Consent decrees, Import detention,Debarment, NIDPOE, AIP

➢ FDA Inspectional Process (continued)

FDA preparation

FDA inspectional approach

Types of employees who conduct FDA inspections

FDA’s risk-based approach to inspections

FDA today

Current inspectional approach

The world according to Turbo

Anatomy of an inspection

➢Planning for an FDA Inspection at Your Company

Internal preparations

Company inspection plan

Procedures for management of inspections

Inspection pre-planning

Management team

Response team

Conduct a mock inspection

Pre-arrival preparations

Internal audit program

➢They’re Here!

Announced or unannounced inspection

Notification

Once in inspection room

During the Inspection

Staging room

Electronic records

CAPA

Dos & don’ts

Key tips for a smooth inspection process

Closing the inspection

Annotating the FD483

➢Post Inspection

Responding to an FD483

Tips for a smooth post-inspection process

The aftermath

Follow-up activities

➢Current FDA Inspectional Trends for GCP, GLP and GMP

➢FDA Top 10 Inspectional Findings Used in Turbo EIR

2. Management of Regulatory Agency Inspections SOP

To View Complimentary Excerpt Click Here

This seven (7) page SOP describes the procedure for the facilitation of a regulatory inspection at a drug sponsor facilityby the U.S. Food and Drug Administration (FDA), Health Canada, European Evaluations Agency (EMEA), or other regulatory agencies regulating pharmaceutical drug development.

The procedure section of this SOP includes 30+ actions and responsibilities for effective management of a regulatory agency inspection.

Managing FDA GXP Inspections CONTENT Package is only $99.00: