ISPE LA Logo

DATA INTEGRITY

Will Issues Around Data Integrity Ever End?
Will Future Technologies Reduce the Risk?

Speakers:

  • Joe Maguire, Senior Director, Regulated IT, Atara Biotherapeutics, Inc.
  • Bob Buhlmann,Director, Corporate Quality Assurance, Amgen, Inc.
  • Ron Brunelle, Quality Assurance Director, Amgen

 

Grifols Campus

 

 


Atara Biotherapeutics Strategy to Become a Paperless Plant

Presented by: Joe Maguire, Senior Director, Regulated IT, Atara Biotherapeutics, Inc.

“Atara is committed to delivering a paperless plant, but it needs to be implemented in phases with a strong strategy to be successful.”

Items to be discussed are: 

  1. Atara IT strategy
  2. Atara IT phased approach
  3. High level Atara systems slide 4. Obstacles for our small company
    1. Roles/Responsibilities
    2. Decision makers
    3. Configuration vs Customization
    4. Data integrity
  4. 5. Keeping the end in mind
    1. Validation
    2. Data management
    3. Labels
    4. Reports

Amgen’s Data Integrity Program

Presented by: Bob Buhlmann, Director, Corporate Quality Assurance, Amgen Inc. 

Items to be discussed are:

  • Contract labs
  • Outsourced manufacturers
  • Transition from data integrity to data quality

Data Integrity: ISPE’s New Baseline® Guide 5 Commissioning and Qualification and Challenges of Moving to a Paperless Validation System
Presented by: Ron Brunelle, Quality Assurance Director, Amgen

Items to be discussed are:

  • New ISPE Baseline Guide 5 Commissioning and Qualification

Challenges and opportunities of moving to a paperless validation system

DETAILS


Sponsors

ISPE LA Platinum Sponsors

REGISTER