All times mentioned are CEST.
Sprecher
Dr Franz Schönfeld, GMP Inspector
Dr Wolfgang Schumacher, formerly F. Hoffmann-La Roche
Francois Vandeweyer, formerly Janssen Pharmaceuticals
Zielsetzung
All important elements of Data Integrity inspection, the Data Integrity self-inspection and the customer Data Integrity audit processes will be discussed. Furthermore, you will be informed about the importance of Data Integrity for the daily business in all areas of the company. Moreover, you will obtain a comprehensive overview of the regulatory requirements and recent audit and inspection trends.
As a production, QA or QC professional you will benefit by learning what the potential problem areas are – so you can take appropriate actions. You will become familiar with the audit tools that are available to you. And you will also have a chance to review and discuss current GMP compliance issues with the speakers.
Zielgruppe
It is further intended for professionals who are responsible for GMP Compliance and Auditing, at both the beginner and advanced levels. Regulatory professionals who are responsible for FDA inspections should also attend. All attendees will gain practical knowledge in establishing an effective Data Integrity compliance audit program
Technical Requirements
For our Live Online Training Courses and 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.
Programm
- Data Integrity inspections as part of general GMP inspections
- What the inspectors look at
- Typical findings at Data Integrity inspections
- Electronic documentation and paper documentation
- Static vs. dynamic data
- Direct vs. indirect impact data
- GMP – GLP – GCP – GDP data
- Critical service provider data
- The PQS
- Data governance
- DI Risk assessments
- The Data Integrity program
- Introduction presentation
- Example 1: Production batch records
- Example 2: Calibration records
- Example 3: Rejected batches
- Lab risk-based approach
- LIMS challenges
- Supplier pre-set lab equipment
- Logbooks
- Key questions to be asked in IT departments
- The role of IT in Data Integrity
- Key Data Integrity requirements for software
- ISA 95 systems
- APIs/dosage forms
- Chemical vs. Biotechnology
- CPP - Design Space Parameters
- Scope and audit team
- What to check?
- Critical areas / Security / Data privacy
- Pros and cons of remote audits
- Definition in the audit SOP and the annual audit program
- Remote audit process
- Business process mapping
- Data and system categorisation, including System assessment
- Risk assessment and remediation
- Some examples
- Area/ processes /system to cover
- Specific questions to consider
Dieses Seminar/Webinar kann nicht gebucht werden. Alternative Termine für dieses Seminar/Webinar und ähnliche Veranstaltungen finden Sie in der Übersicht nach Thema..
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Oder senden Sie uns Ihre Anfrage einfach über das folgende Kontaktformular.
This course is part of the GMP Certification Programme "ECA Certified Data Integrity Manager"
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E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Seminarprogramm als PDF
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