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

23-25 October 2019

Vienna, Austria

Seminar Nr. 16949

Unser Seminarservice

Kosten

Non ECA Member:	EUR 1990,--
ECA-Member:	EUR 1790,--
EU/GMP Inspectorates:	EUR 995,--
APIC Member Discount:	EUR 1890,--

Alle Preise zzgl. MwSt.

Zur Anmeldung

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Martin M. Appel, Cilag AG /Johnson & Johnson
Katja Kotter, Vetter PharmaFertigung
Savvas Koulouridas, Fagron BV
Dr Jean-Denis Mallet, form. Head of the French Pharmaceutical Inspection Department (AFSSAPS, now ANSM)
Markus Roemer, comes compliance services
Mark Tucker, Ph.D, form. US FDA Investigator and Compliance Officer
Thomas Noe Vestergaard Pedersen, Danish Medicines Agency

Zielsetzung

You will understand the purpose and organisation of regulatory inspections and you will learn how to prepare your company to pass an inspection or customer audit and how to assure the most positive outcome.

Get practical knowledge of:

What inspectors are looking for
Successful preparation and management of
inspections
Typical compliance issues and proactive compliance
Performing a MOCK-Inspection (also for Data
Integrity)
How legal department can support
Latest trends

In addition, you will hear examples from global inspections to gain a better understanding of what is expected.

Hintergrund

GMP audits and inspections are fundamental elements of managing quality in the pharmaceutical industry. On the one hand, pharmaceutical companies have to perform supplier audits. And on the other hand, the pharmaceutical companies as well as the suppliers are frequently inspected by the authorities (both national and international inspectorates like the FDA) as a central element of supervision.

For the company, an inspection can have a decisive influence on the daily work and its economic future. A sound and thorough preparation is an essential key to successfully pass an inspection.

Zielgruppe

This GMP Education Course is designed for all persons involved in preparing, managing and escorting audits and inspections.

Note: The number of participants is limited.

Free tool for inspection preparation:

As a participant you will get a detailed checklist for inspection preparation (40 pages). This checklist can be adapted to prepare your pre-approval inspections, routine inspections or customer Audits.

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 Inspections

Internal Audit and Mock-Inspection
Audit strategy
Roles and Responsibilities
Communication and co-operation
Sequence of preparation steps
Co-operation with customers and external auditors

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 management

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

The Follow-up

How to reply to report and observations
Dissent and dispute
Proof of CAPA effectiveness
Ensuring that measures are implemented company-wide
What to do if a target date can not be achieved

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 workshop includes a simulation of an inspection situation (role play).

Session 2
What would you do if … (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.

Session 3
Data Integrity

GMP process and laboratory data flow
Preparing and presenting data sources and data governance for an inspection

Zurück

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