ECA Training: Inspection Management – How to Pass EU and FDA Inspections

You will understand the purpose and organisation of regulatory inspections and you will learn how to prepare your company to pass an inspection or customer audit and how to assure the most positive outcome.

Get practical knowledge of:

  • What inspectors are looking for
  • Successful preparation and management of Inspections
  • Typical compliance issues and proactive compliance
  • Performing a MOCK Inspection
  • The psychology of inspections

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ECA Training: Hamburg, Germany

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PTS Schulung: GMP Datenintegrität am 13.-14.06.2017 in Baden-Baden

Die Datenintegrität der GMP-Daten ist ein zentrales Inspektionsthema. In diversen US FDA Warning Lettern als auch EMA GMP Reports werden bereits entsprechende Mängel dargestellt. Im Seminar lernen Sie die Anforderungen an die Datenintegrität kennen und Sie erfahren die aktuellen Richtlinien und Inspektionsergebnisse.

PTS Schulung am 13.-14.06.2017 in Baden-Baden:

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Teilnehmerfeedback aus dem letzten Kurs:

Inhalte sehr detailliert und praxisnah; gute Darbietung; lebhafte Diskussion Gute Atmosphäre; aktive Mitarbeit; Zahlreiche Workshops und praktische Beispiele waren super!


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Kontakt: talk@comes-services.com

PTS Seminar: GMP Datenmanagement – Behörde und Industrie im Dialog

Seminar, 30.03.2017 in Unna bei Dortmund

Bedeutung des Data Governance Systems für die Pharmawelt:

  • Von messbaren Datenparametern: Sicherstellung von Datenintegrität, Vertraulichkeit, Verfügbarkeit, Authentizität, Verbindlichkeit
  • Von der Datenerhebung und Datenerfassung, über Datendokumentation, Datenverwendung / Prozessieren, Datenablage zur Datenarchivierung
  • Von Entwicklungsdaten, zu Prozessdaten, zu qualitätsrelevanten Freigabedaten, Qualitätskennzahlen zum digitalen Information Management über den gesamten Life-Cycle
  • Hin zur Frage: Was sind Faktoren der digitale Wertschöpfungskette in der Pharmaindustrie?

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CCS – 100 – business customers reached in 2016

comes compliance services (CCS), a leading GXP consulting service provider, for Pharmaceutical Quality Systems, Data Governance and Integrity, Computer System Validation and Inspection Readiness Programs, today announced that it has acquired more than 100 business customers since the launch of its services in 2009. Pharmaceutical and Medical Device customers rely on the compliance and consultancy services since many years provided by CCS. About 80 % of CCS projects are repeat-business and sales continue to ramp steadily. Continue reading “CCS – 100 – business customers reached in 2016”

Draft PIC/S Good Practices for Data Management and Integrity

PIC/S has published on a draft basis a guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1 (Draft 2)) developed by the PIC/S Working Group on Data Integrity. This draft guidance will be applied on a 6-month trial basis by PIC/S Participating Authorities. This draft document results from the need among Inspectorates to have access to harmonised data integrity guidance, considering the impact to public health. The purpose of the trial-period is to learn from implementation. It is acknowledged that the guidance requires expanding in some areas; however, the document has value in describing foundational principles which can be enhanced in future revisions. This draft document is not open for comments by industry. Formal adoption of the guidance will proceed in accordance with PIC/S procedures – including a stakeholders’ consultation – on a revised version after completion of the trial-period.

Download: PI_041_1_Draft_2_Guidance_on_Data_Integrity_2