Data Integrity Audits & Inspections
Im Auftrag der ECA Academy

Data Integrity Audits & Inspections Im Auftrag der ECA Academy

Prague, Czech Republic

Seminar Nr. 17756


Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

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

Zielsetzung

This education 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 with participants’ collaboration 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.

Zielgruppe

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.

Two Data Integrity Checklists!

All participants will receive two Data Integrity Checklists. One Checklist has been developed by APIC/CEFIC, the second Checklist has been developed by ECA´s Data Integrity IT Compliance Group. Both Checklists will be available in electronic format for daily use!

Programm

Data Integrity Inspections from the Inspector´s point of view
  •  Data Integrity Inspections as part of general GMP Inspections
  •  What the Inspectors looks 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
Workshop I
Real life practical examples (non lab related)
Attendees to build up a DI inspection strategy
  • Introduction presentation
  • Example 1: Production batch records
  • Example 2: Calibration records
  • Example 3: Rejected batches
Laboratory DI inspections
  • Lab risk-based approach
  • LIMS challenges
  • Supplier pre-set lab equipment
  • Logbooks
Workshop II
Participants develop an agenda for an audit of a SaaS service provider
  •  Scope and audit team
  •  What to check?
  • Critical areas / Security / Data Privacy
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
Workshop III
Laboratory Self-inspections
  • How to develop a risk-based lab self inspection programme
  • Discuss two practical examples
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

Zurück

GMP Seminare nach Thema

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