Inspection Management - How to Pass EU and FDA Inspections

Programme

The Challenges of GMP Audits and Inspections
Regulatory requirements
Purposes and reasons for GMP inspections
Audit types

Authority Expectations: some practical Examples from a former EU Inspector
Organisations, agencies and inspections worlswide and their differences
Experiences from an ex-inspector’s point of view
What to expect, when being inspected in the near future

The View of a former MHRA Inspector
Quality management systems and their assessment
Improvement through auditing and benchmarking

The View of a former FDA Inspector
The FDA Inspection System
Classification of GMP deficiencies/Examples of critical deficiencies
FDA inspection findings
What does the inspector expect when he arrives at your site
What the FDA will look for
PAI vs. System Inspection
What happens at FDA during and after the Inspection
Responding to FDA (483, Report, Warning Letter)
Hot topics and trends in the agency that will result in future GMP guidance updates

Typical Compliance Issues
Quality System
Laboratory control
Production
Material Management
Facility & Equipment
Packaging and labelling

How inspectors are trained
What makes a good Inspector
Skills needed
Information transfer between inspectorates

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
Lay-out of the Back Room
Inspection workflow and definition of functions
Docket system

The Psychology of Inspections
Who is in charge?
How to deal with conflicts
What if you don’t agree with an inspector?
Body language of inspector and auditee
Some “tricks of the trade”
The Dos and Don’ts

Case Study: The juristic Perspective - how legal Department can support QA
Preparation
Attendance
Direct Inspection Support
Replies and Response to Inspection Reports

Workshop
Proactive Compliance and Inspection Management – it’s more than Self Inspection
Case Study: An Inspection Management Risk Model
How to increase inspection risk-awareness
Risk categorisation and ranking
Risk reduction prioritization
Reporting of the results to senior managemen

Parallel Workshops
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.

Workshop 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).

Workshop 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

Workshop 3
Know your GMPs
An interactive review of different GMP scenarios which will take into account your knowledge of GMPs and enable detailed discussions on the
implications of the actions taken.