Live Online Training - Data Integrity Audits & Inspections

Live Online Training - Data Integrity Audits & Inspections

Course No 18484

This course is part of the GMP Certification Programme "ECA Certified Data Integrity Manager". Learn more.

All times mentioned are CET

Costs

Registration is no longer possible. Please contact us if you would like to order a recording:

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

Speakers

Danny De Scheemaecker, Janssen Pharmaceuticals
Dr Franz Schönfeld, GMP Inspector
Dr Wolfgang Schumacher, formerly F. Hoffmann-La Roche
Francois Vandeweyer, formerly Janssen Pharmaceuticals

Objectives

This online training course will discuss the practical and proven techniques for conducting effective self-inspections/audits of various pharmaceutical operations, to identify the critical deficiencies associated with Data Integrity. A combination of presentations and case studies will be offered to provide a maximum learning experience.

Participants will get to know all important elements of the Data Integrity inspection, the Data Integrity self inspection and the customer Data Integrity audit processes. 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.

Target Group

This training course is designed for QA, QC and production professionals as well as GMP auditors who intend to specialize in Data Integrity auditing and who are facing  FDA and EU inspections. 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 programme.

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

Data Integrity Inspections from the Inspector's Point of View
  •  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
Critical Data – Which Ones must be Audited?
  •  Static vs. dynamic data
  •  Direct vs. indirect impact data
  •  GMP – GLP – GCP – GDP data
  •  Critical service provider data
Quality System / Data Governance Self-Inspection
  •  The PQS
  •  Data governance
  •  DI risk assessments
  •  The data integrity program
Real Life Practical Examples (non lab related)
  • Introduction presentation
  •  Example 1: Production batch records
  •  Example 2: Calibration records
  •  Example 3: Rejected batches
Laboratory Data Integrity Inspections
  • Lab risk based approach
  • LIMS challenges
  • Supplier pre-set lab equipment
  • Logbooks
Informatics (IT) Self-Inspections
  • Key questions to be asked in IT departments
  • The role of IT in Data Integrity
  • Key Data Integrity requirements for software
Discussion, Q&A
 
Production Self-Inspections
  • ISA 95 Systems
  • APIs/Dosage forms
  • Chemical vs. biotechnology
  • CPP - Design Space Parameters
How to Develop an Agenda for an Audit of a SaaS Service Provider
  • Scope and audit team
  • What to check?
  • Critical areas / security / data privacy
 How to Leverage the ISO 19011 Section for Remote Audits to the GMP Area
  •  Pros and Cons of remote audits
  •  Definition in the audit SOP and the annual audit program
  •  Remote audit process 
Risk-Based Data Integrity Assessments
How to identify gaps in your system :
  •  Business process mapping
  •  Data and system categorisation, including System assessment
  •  Risk assessment and remediation
  •  Some examples
Data Integrity (Self) Assessments
How to identify and detect potential risks for Data Integrity failures:
  • Area/ processes /system to cover
  • Specific questions to consider

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