header-image

GMP Data Governance - Principles for Data Integrity Assurance
Im Auftrag der ECA Academy

22-23 March 2018, Copenhagen, Denmark

Seminar-Nr. 16112

Sprecher

Dr Christopher Burgess, Chairman of the ECA Quality Control Group

Klaus Eichmüller, Wolnzach c/o Regional Council Darmstadt, GMP Inspectorate, Germany

Dr Bob McDowall, Member of the ECA IT Compliance Interest Group

Roland Miksche, Shire, Vienna, Austria

Margarita Sabater, Member of the ECA Quality Control Group

Philip Vaering, Team Leader in Process and Technical Support, ALK-Abelló A/S, Denmark

Zielsetzung

The objectives of this ECA educational course are to provide:

  • An understanding of the scope of data governance within a pharmaceutical quality system
  • The roles and responsibilities of senior management for data governance
  • Roles and responsibilities of data owners and data stewards in ensuring data integrity of specific systems and processes
  • Ensuring the correct culture for data integrity

Hintergrund

Data integrity is the hottest regulatory topic today in GMP as a result of inspectors finding poor data management practices and data falsification. As a result, guidance documents have been issued by MHRA and WHO with other guidance due from EMA and PIC/S. In these documents, there is the phrase “Data Governance” used. The same definition of the term is used by MHRA and WHO:

The sum total of arrangements to ensure that data, irrespective of the format in which it is generated, is recorded, processed, retained and used to ensure a complete, consistent and accurate record throughout the data lifecycle.

As guidance, the “sum total of arrangements” is not very illuminating or informative. In fact, the definition of data governance from the draft WHO guidance starts with the phrase “Management leadership …” which is much more informative and focussed.

This course is designed to help GMP organisations understand the term and implications of data governance. Data governance and data integrity is not just about correct numbers, it is much more than that and involves management leadership, influencing others, change of culture, effective training and personal honesty.

Zielgruppe

  • Managers and staff from Manufacturing, QC/QA and Analytical Development Laboratories of pharmaceutical companies
  • Contract Research Organisation and Contract Manufacturing Organisation manufacturing, laboratory and QA personnel
  • Auditors (internal and external) responsible for performing self-inspections or external audits and needing to understand and assess data integrity

Programm

Setting the Scene: Introduction to the Course and Scope of Data Governance

  • Data Integrity Model with focus on Data Governance
  • Definitions of Data Governance
  • Scope of Data Governance in ensuring Data Integrity: Who is involved?
Regulations and Regulatory Guidance for Data Handling - Expectations of an EU GMP Inspector
  • GMP Regulations – EU
  • ICH Q10
  • Data integrity guidance documents - EMA, WHO, and others
Case Study: Corporate Data Integrity Policy
  • Scope and content
  • Authorship and Approval
Data Governance Roles and Responsibilities
  • Who is involved – in the whole organisation
  • What do they have to do?
Workshop 1: Content of the Data Integrity Policy
  • Work on specific sections of the policy in groups
Case Study: Corporate Culture and Organisation for Data Governance and Data Integrity
  • Role of Senior Management
  • Interdependencies of function
  • How to implement the change process
Data Owners and Data Stewards
  • What do they have to do?
  • Roles and responsibilities
  • Identifying and training the individuals
Workshop 2: Defining Roles and Responsibilities for Data Owners, Stewards, Staff & IT
  • Laboratory
  • Production
  • Quality Assurance Systems
Changing the Culture of an Organisation
  • What is required?
  • Behaviours: no blame culture & whistleblower line
  • Defining expectations: expected and prohibited actions with consequences
  • Delivering change
Data Integrity Training
  • Learning from outside the pharmaceutical industry
  • Linking the data integrity policy and local procedures for processes and systems
  • Assessing and measuring understanding
Data Integrity Audits of Processes and Systems
  • Data Life cycle for manual and automated processes
  • What data integrity controls are required throughout the life cycle?
  • Security and confidentiality considerations
Investigating Data Integrity Violations
  • Global GAP Analysis and Data Integrity Control Strategies
  • Identifying data integrity GAPs in a global organisation
  • Ensuring focus on the most critical systems and issues (risk based approach)
  • Driving global data integrity projects
  • Data Integrity control strategies
Workshop 3: Auditing a System and Identifying Data Integrity Problems
  • Laboratory
  • Production
  • Quality Assurance Systems

Dieses Seminar/Webinar kann nicht gebucht werden. Alternative Termine für dieses Seminar/Webinar und ähnliche Veranstaltungen finden Sie in der Übersicht nach Thema..

Für viele Seminare und Webinare gibt es auch Aufzeichnungen, die Sie jederzeit bestellen und anschauen können. Diese Aufzeichnungen finden Sie in einer themensortierten Liste.

Oder senden Sie uns Ihre Anfrage einfach über das folgende Kontaktformular.

* auch unkompliziert per Kreditkarte bezahlbar
American Express Visa Mastercard

icon
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
icon
Weitere Termine online
Weitere Termine online nicht verfügbar
icon
Aufzeichnung nicht verfügbar

Haben Sie noch Fragen?

Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de

Frau mit Headset

Zurück

Teilnehmerstimmen - das sagen andere über unsere Seminare:

Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis,
welche die Theorie super veranschaulicht.”
Marina Kicoranovic, Labor Hartmann GmbH
GMP/Basis-Einstiegsschulung (B 14), September 2023

Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe
verwendet (super) und waren sehr praxisbezogen.”
Astrid Gießler, Regierungspräsidium Karlsruhe
Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023

Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.”
Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG
GMP-Basisschulung (B 1), Juni 2023

NEWSLETTER

Bleiben Sie informiert mit dem GMP Newsletter von Concept Heidelberg!

GMP Newsletter

Concept Heidelberg bietet verschieden GMP Newsletter die Sie auf Ihren Bedarf hin zusammenstellen können.

Hier können Sie sich kostenfrei registrieren.

Kontakt

Kontaktieren Sie uns

Haben Sie Fragen?

Concept Heidelberg GmbH
Rischerstraße 8
69123 Heidelberg

Tel. :+49622184440
Fax : +49 6221 84 44 84
E-Mail: info@concept-heidelberg.de

zum Kontaktformular