Inspection Management - How to pass global GMP Inspections
Im Auftrag der ECA Academy

Programm

The Challenges of GMP Audits and Inspections

• Regulatory requirements
• Purposes and reasons for GMP inspections
• Audit types

The View of a former EU Inspector: Authority expectations - some practical examples

• Organisations, agencies and inspections worldwide and their differences
• Experiences from an ex-inspector’s point of view
• What to expect, when being inspected in the near future

What makes a good Inspector

• How inspectors are trained
• Skills needed
• Inspection preparation, strategy and tactics
• Information transfer between inspectorates

The View of a former FDA Inspector:

• The MRA between the U.S. and the EU: The future of FDA inspections, FDA inspections despite MRA, What FDA will expect from EU sites
• FDA’s Quality Metrics Initiative: Current Status
• The FDA Inspection System: Classification of GMP deficiencies/Examples of critical deficiencies, What does the inspector expect?, PAI vs. system based inspection, What happens at FDA during and after the Inspection, Responding to FDA (483, Report, Warning Letter), Hot topics and trends

Experiences with various Inspectorates (what you need to know)

• Brazil (ANVISA)
• Mexico (COFEPRIS)
• Turkey (MOH)
• Russia (FSI SID&GP)
• Saudi-Arabia (SFDA)
• Taiwan (TFDA)

Typical Compliance Issues

• Quality System
• Laboratory control
• Production
• Material Management
• Facility & Equipment
• Packaging and labelling

The MOCK Inspection: Auditing your Company to prepare for international Inspections

• Internal audit expectations
• Audit hierarchy
• EU and FDA cGMP differences
• Quality System audit details
• Audit strategy and cycle
• Rolls and Responsibilities

Preparation and Management of Regulatory Inspections

• Tools to successfully manage regulatory inspections
• Features of on-line communication tools, e.g. NetMeeting, WebMeeting
• Layout of the Back Room
• Inspection workflow and definition of functions
• Docket system

Case Study: The juristic Perspective - how Legal can support QA

• Preparation
• Attendance
• Direct inspection support
• Replies and response to inspection reports

Parallel Sessions
You will be able to attend two of these parallel sessions. Please choose the 2 sessions you would like to attend when you register for the course.

Session 1
Preparing for a Regulatory Inspection (with Inspection Simulation)
Team building
Gap analysis and action plan
Roles and responsibilities
Training of the staff
Function of moderator, escorts and experts
The workshops includes a simulation of an inspection situation (role play).

Session 2
Risk Analysis related to the Inspection and Findings
Conceptualisation of the “Risk”
What is an inspection / audit finding
Pre-existing classifications
Quality Risk Management & GMP Findings

Session 3
Data Integrity
GMP process and laboratory data flow
Preparing and presenting data sources and data
governance for an inspection