Live Online Training: Inspection Management

Live Online Training: Inspection Management

Course No 18405

All times mentioned are CET.

Costs

ECA-Member: EUR 1490,--
Non ECA Member: EUR 1690,--
EU/GMP Inspectorates: EUR 845,--
APIC Member Discount: EUR 1590,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Katja Kotter, Vetter Pharma-Fertigung
Dr Jean-Denis Mallet, form. Head of the French Pharmaceutical Inspection Department (AFSSAPS, now ANSM)
Edel Ryan, Mylan
Dr Anke von Harpe, QProgress

Objectives

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
  • Latest trends (with a view on virtual/remote audits)
In addition you will hear examples from global inspections to gain a better understanding of what is expected.

Background

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.

Target Group

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

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

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
The FDA Approach
  • The MRA between the U.S. and the EU and ist consequences
  • The FDA Inspection System
  • What does FDA expect?
  • Responding to FDA (483, Warning Letter)
Preparing for a Regulatory Inspection
  • Team building
  • Gap analysis and action plan
  • Roles and responsibilities
  • Staff Training
  • Function of moderator, escorts and experts
  • Virtual (remote) audits
Experiences with Various Inspectorates (What You Need to Know)
  • Brazil (ANVISA)
  • Mexico (COFEPRIS)
  • Turkey (MOH)
  • Russia (FSI SID&GP)
  • Eurasian Economic Union (EAEU)
  • China (NMPA)
  • South Korea (MFDS)
  • 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
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

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