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20 2017 June - LYON
Theme: Data Integrity

Data integrity, paper or electronic format, has become in a few months a major issue for the drug industry and health products.

supervisory authorities have highlighted malfunctions, have published guides and regularly notify industry on this issue.

● How to navigate between texts (GMP, cGMP, 21CFR11 ...) and the new guides (EMA, PIC / S, FDA, MHRA, WHO ...)?
● What are the expected?
● What do the inspection returns?
● What are the approaches taken by manufacturers to respond? In particular, why and how to revise the "audit trails"?
● What are the technical and organizational responses to master data integrity? in the laboratory and in production?

During the day, we will bring you answers via industrial experience feedback (Baxter, GSK, Lilly, Merck, Sanofi ...) and suppliers (Waters, Werum ...) representative of the sector.

REGISTRATION
Fees
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EXHIBITION

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PROGRAM - June 20 2017
The Pier, 13 bis Quai Rambaud, 69002 LYON (FR)

   
  Conferences
09: 00 - 10: 30
 

Data Integrity: Update on Statutory Instruments
Lionel Pelletier - Aktehom

Cost effective data integrity compliance program in a flexible cGMP environment
Thierry Dufrasne & JS Dufrasne- Baxter

The most frequent questions from our customers on the Data Integrity
Dominique Agro - Waters

   
     Visit the exhibition    
  Conferences
11: 30 - 12: 30
 

Data Integrity Laboratory: feedback
Sylvain Plagellat - Merck

MY - The Data Integrity for engine output control strategy in pharma execution 4.0GB chip web 01
Christian Wölbeling - Werum

   
     Lunch exposure    
 

Conferences
13:30 - 15: 00

 

Manufacturing Execution System & Data Integrity - Experience Returnss
Jean-Marc Jehl - Lilly

The review of audit trails: Why? How?
Alain Navarro - Sanofi

Returns inspections on Data Integrity 
Patrick Turlier - GSK

   
     Visit the exhibition    
 

Table ronde
15:30 - 16: 30

 

Q & A discussion moderated by our experts (members of the ICG A3P eCompliance)

  • What Happens between texts (GMP, cGMP, 21CFR11 ...) and the new guides (EMA, PIC / S, FDA, MHRA, WHO ...)?
  • What are the expected?
  • What do the inspection returns?
  • What are the approaches taken by manufacturers to respond? In particular, why and how to revise the "audit trails"?
  • What are the technical and organizational responses to master data integrity? in the laboratory and in production?
   

 

Contact :
Mylène RAT
04 37 28 30 43
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