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

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

Barcelona, Spain

Seminar Nr. 16431


Kosten

Non-ECA Members: EUR 1990,--
ECA Members: EUR 1790,--
EU GMP Inspectorates: EUR 995,--
APIC Members: EUR 1890,--

Alle Preise zzgl. MwSt.

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

Sprecher

Katja Kotter, Vetter Pharma-Fertigung GmbH & Co. KG

Savvas Koulouridas, Fagron Hellas

Dr Jean-Denis Mallet, form. Head of the French Pharmaceutical Inspection Department (AFSSAPS, now ANSM)

Thomas Noe Vestergaard Pedersen, Danish Medicines Agency

Markus Roemer, comes compliance services

Edel Ryan, Mylan, Ireland

Mark Tucker, Ph.D, form. US FDA Investigator and Compliance Officer

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 assurance 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 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 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

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