News

SPAQA 2017 Annual Meeting

We've had a great Annual Meeting !

Speakers:

  • Elisabeth Klenke, Swissmedic: News from the monitoring authority
  • Christine Mitchel, Charles River: Quality risk management and the QA program – Charles River
  • Linzi Gillbanks, Covance Early Development: Risk based auditing – could it work for you?
  • Jean-Claude Cuenat, redtoo AG : My data reached the cloud. Where was it meanwhile?
  • Michael Wegmann, F. Hoffmann-La Roche: Security and compliance considerations for contracts with cloud service providers

These presentations and the Member's General Assembly presentation from Juergen Karg are available to SPAQA members by accessing the Members Only Area of the website 

Download the Questions and Answers of the 2017 SPAQA Authority Roundtable

Download the News from the GLP Monitoring Authorities

Newest Information

Newest News and Information

There is a new OECD draft guidance document on Test Item Characterization posted on the OECD Website. This document is available for public comment until June 22nd. Should you wish to forward your comments via SPAQA, all comments received by 15 June will be forwarded anonymously. Please submit your comments to vorstand@spaqa.ch

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If you are intersested in the SOFAQ meeting:  See their website: http://sofaq.fr/congres-2017/

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The 2017 SPAQA annual dues are now payable. 

If you have paid your 2017 please contact us at vorstandspaqa.ch if you are unable to access the Members only section of the website

In order to pay your dues:    Please pay 100 Sfr to the following Post Finance Account.

Name Swiss Professional Association of Quality Assurance (SPAQA)
Postal Account number40-17421-9
IBAN electronicalCH4909000000400174219
swift code/BICP O F I C H B E X X X
BankSwiss Post, Postfinance, Nordring 8, 3030 Bern, Switzerland
Clearing number 09000

News from the Working Groups

Networking possibilities-

IT group:  The group held an organizational meeting at F. Hoffmann La-Roche in Basel on Oct 26th 2016 and a second meeting on January 18,2017. 

We will have another meeting of the group in Summer 2017. 

Interested in becoming a member : Contact vorstandspaqa.ch

 

GLP Group: The GLP Working group met on 24th January. Questions for the GLP Monitoring Authority Roundtable were discussed. Interested in becoming a member or attending the meeting: Contact vorstandspaqa.ch

 

GMP Group: Contact Juergen.Kargthermofisher.com  

Recent OECD or AGIT releases

Draft Documents

OECD Draft Document on Test Item Characterization available for public comment until 15 June 2017 via Vorstand@spaqa.ch

 

Finalized Documents

OECD Advisory document on Peer Review (OECD 16).

OECD Advirory document Application of GLP Principles to Computerised Systems (OECD 17 replaces OECD 10)

AGIT Position Paper on the  Destruction of Paper copies of raw data.

SPAQA Annual Meeting Presentations Available

The presentations from the 2012-2017 SPAQA Annual Members meetings and Annual Meetings are available in the SPAQA Members Only area.

The presentations from the 2012 Cloud Symposium are also available in the Members Only area. 

The presentations from the 2012 and 2013 GLP Monitoring Authority Roundtable are also available for download. See GLP Roundtable tab.

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