Live Online Training: GMP-Auditor Practice

Live Online Training: GMP-Auditor Practice

Course No 18249

All times mentioned are CEST.

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

Ágnes Kis, form. GMP-Inspector at OGYÉI, Hungary
Christof Langer, OSConsulting, Austria
Thomas Højsholm Schmidt, Leo Pharma, Denmark

Objectives

In this Live Online Training you will have the possibility to learn and intensively discuss how to focus on specific GMP related aspects.

Background

Continuous professional training for auditors and lead auditors is of utmost importance as the authorities expect qualified personal performing audits. And GMP audits of suppliers, contract manufacturers and contract laboratories are a fundamental part of a Quality Management System to assure the quality of a drug product. Only knowledgeable and highly qualified auditors with a profound technical knowledge and good communication skills can guarantee audits that are useful for both the auditing company and the auditee.
 
Recognising this need for further professional knowledge development, the ECA Academy has set up this Live Online Training as an individual course which is also part of ECA’s Certified GMP Auditor Programme.

Target Group

This Live Online Training is designed for both new and experienced auditors. It can also be seen as an addition to the ECA Course “The GMP-Auditor”.

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

Programme 21 October 2020

09.00 – 09.10 h Welcome & Introduction

09.10 – 10.45 h
How to audit Quality Systems
  • What should be included in a Quality System’s audit
  • Pitfalls when auditing Quality Systems
  • How to detect Quality System issues
10.45 – 11.00 h Break

11.00 – 12.15 h
How to audit Production of solid Dosage Forms
  • Risk-based approach
  • Key points to consider
  • Exercise with role play
12.15 – 12.45 h Q&A Session

12.45 – 13.45 h Break

13.45 – 15.00 h
How to audit Production of sterile Dosage Forms
  • Key essentials and points to consider
  • Case studies
15.00 – 15.15 h Break

15.15 – 16.30 h
How to audit Data Governance and Data Integrity
  • Examples of data governance and data integrity issues
  • Implications of data integrity issues
  • Auditors role in data integrity governance
  • Developing a data integrity audit program – “Hands-on Approach”
16.30 – 17.00 Q&A Session

Programme 22 October 2020

08.30 – 08.35 h Welcome & Introduction

08.35 – 09.45 h
How to audit Engineering and Technical Operations
  • HVAC systems
  • Water systems
  • Utilities
    • Pressured air
    • Clean steam
    • Special gases
  • Room qualification
  • Facility layouts
  • Flow of material and waste
09.45 – 10.00 h Break

10.00 – 11.15 h
How to perform Quality Control Laboratory Audits
  • Sample receipt and registration
  • Sample preparation
  • Equipment Calibration and Maintenance
  • Reporting
11.15 – 12.30 h
How to audit microbiological laboratories
  • Where to look at
  • Interpretation of microbiological Data
  • Examples
12.30 – 13.00 h Q&A Session

13.00 – 14.00 h Break

14.00 – 15.15 h
How to perform an API Site Audit (chemical)
  • Dedicated vs. multiple purpose facility
  • Material dispensing
  • Cross-Contamination
  • Process and cleaning Validation
  • Utilities
15.15 – 15.30 h Break

15.30 – 16.45 h
How to perform an API Site Audit (biotech)
  • Cell banks
  • Inoculation
  • Fermentation
  • Harvest
  • Purification
16.45 – 17.00 h Q&A Session

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