Inspection Management
Im Auftrag der ECA Academy

Inspection Management Im Auftrag der ECA Academy

Hamburg, Germany

Seminar Nr. 17519


Kosten

ECA-Member: EUR 1990,--
Non ECA Member: EUR 2190,--
EU/GMP Inspectorates: EUR 1095,--
APIC Member Discount: EUR 2090,--

Alle Preise zzgl. MwSt.

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

Sprecher

Katja Kotter, Vetter Pharma-Fertigung
Savvas Koulouridas, Fagron BV
Dr Jean-Denis Mallet, form. Head of the French Pharmaceutical Inspection Department (AFSSAPS, now ANSM)
Markus Roemer, comes compliance services
Edel Ryan, Mylan
Thomas Noe Vestergaard Pedersen, Danish Medicines Agency 
Dr Anke von Harpe,  QProgress

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.

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 FDA Approach
  •  The MRA between the U.S. and the EU and ist consequences
  •  FDA’s Quality Metrics Initiative
  •  The FDA Inspection System
  •  What does FDA expect?
  •  Responding to FDA (483, Warning Letter)
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
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 two 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

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