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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 This draft guidance will be applied on a 6-month trial basis by PIC/S Participating Authorities.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

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FREE Webinar: Practical Introduction to Data Integrity in 30 minutes

EQMS experts Mark Stevens, Operations Director and Principal Consultant from Formpipe Life Science and Markus Roemer, Consultant from comes compliance services (www.comes-services.com) will share their combined knowledge during a two part webinar series focusing on one of the industries most talked about topics of 2016 – Data Integrity.

Part 1 – June 15 2pm GMT/3pm CET/ 9am EST
Practical Introduction to Data Integrity in 30 minutes

This webinar covers what’s it all about, where to start and what is actually useful to you and your Organisation.

Formpipe will uncover practical approaches to managing Data Integrity compliance that fulfil the regulatory requirements such as 21 CFR Part 11 and Annex 11.  They will provide useful insights into the impact of the recent Data Integrity guidance as well as clarify what hasn’t changed and provide practical tips to address them in a straightforward way.

Register for free

Coming next: Part 2 – June 22 GMT/3pm CET/ 9am EST

Managing your Data Integrity responsibilities without creating a resource monster

 

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PTS Training: GMP Datenintegrität – 29.-30.06.2016 in Karlsruhe

Datenintegrität im Brennpunkt der Inspektionen und Audits

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 Inspektionsergebnisse.

Das brandaktuelle Dokument der FDA vom April 2016 ist in das Programm eingebaut: Data Integrity and Compliance With CGMP, Guidance for Industry, DRAFT GUIDANCE

Ihre Referenten am 29.-30.06.2016 in Karlsruhe sind:

Dr. Christian Gausepohl, Rottendorf Pharma GmbH
Markus Roemer, comes compliance services

Lesen Sie mehr und zur Anmeldung…

 

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US-FDA Guidance for Industry Data Integrity and Compliance With CGMP

After MHRA and WHO have drafted their guidance documents on Data Integrity the US-FDA has published in April 2016 the Guidance for Industry for CGMP compliance (DRAFT Version).

The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practices. The guidance outlines US-FDA’s current thinking regarding the narrow scope and application of part 11 pending FDA’s reexamination of part 11 for 2003 as it applies to all FDA-regulated products.

Further reading / references:

Download at PDA the free code of conduct document for data integrity: Open External Link

For more information feel free to contact us at: talk@comes-services.com

 

 

 

 

 

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11th Qualified Person Forum, 1-2 December 2016, Madrid, Spain

The QP Forum conference is designed by QPs for QPs as an international Expert Forum with focus on sharing information and experience and on discussing the critical areas of the QP’s daily work.

Case Study – Data Integrity:

Why it is so important for QPs? How can the QP be sure about the integrity of data: what to focus on, what to check?

  • presented by Markus Roemer, comes compliance services

 

More Information and register online: OPEN EXTERNAL LINK

 

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Excellence Seminar am 14. Juli 2016 in Stuttgart

Sie sind Geschäftsführer, Führungskraft oder Entscheidungsträger und haben wenig Zeit sich mit vielen Details zu beschäftigen und müssen doch die richtigen Entscheidungen treffen. Dieses Seminar soll in jeweils 100 Minuten einen Überblick über die Themen US-FDA Inspektionen, Inspection Readiness (Data Governance, elektronische Daten) und OPEX bis Industrie 4.0 vermitteln. Wo sind bei Investitionen entsprechende Schwerpunkte sinnvoll oder unbedingt notwendig und gibt es heute dazu schon Erfahrungen aus der Praxis. Continue reading “Excellence Seminar am 14. Juli 2016 in Stuttgart”