GMP Webinar: Current Inspection Trends

GMP Webinar: Current Inspection Trends

Course No 16983


Costs

Non-Members: EUR 199,--
Members: EUR 149,--

(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

Dr Rainer Gnibl, GMP Inspector, District Government of Upper Bavaria, Germany
Dr Rainer Gnibl is pharmacist and GMP Inspector for the District Government and the EMA and performs GMP inspections worldwide. Before that, he was working for the Bavarian Ministry of Environment and Health. Rainer Gnibl also holds a lectureship at the University Erlangen-Nürnberg.

Background

GMP inspections by the supervising authorities are an important element in ensuring the quality of medicines. For the company, an inspection can have a decisive influence on the daily work and its economic future; for example, the issue or renewal of the Manufacturing and Importation Authorisations (MIA) requires a positive GMP inspection
outcome. For a successful inspection it is essential to know the expectations of the authorities.

Target Group

The webinar is aimed at executives and employees from the pharmaceutical industry who want to get a compact and comprehensive overview of current inspection expectations.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.htm 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 goal of this webinar is to give attendees a comprehensive yet compact overview of the current inspection highlights:

  • What are the current hot topics?
  • What are the inspectorates currently seeing as the
  • biggest problems?
  • What are the future developments?
  • How do authorities co-operate? Co-ordination of activities - Information Exchange - Mutual recognition of inspections
  • What can the industry learn from this?

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