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TAMPA 2011 CONFERENCE
E02 Quality Risk Management: Focused, Practical Application
John Hannon and Dave Dolgin
Monday and Tuesday 21-22 February 2011
Tampa, FL
http://www.ispe.org/2011tampaconference/qualityriskmanageme
nt
Monday, 21 February
Start
Time
7:00
7:30
9:00
End Time Presentation Title
8:00
9:00
9:15
Speaker / Leader Breakfast (invitational)
Breakfast
Introduction to the Seminar
Speaker Full
Name
Company
John Hannon
Commissioning
Agents
Abbott
Abbott
Dave Dolgin
Dave Dolgin
9:15 10:00
10:00 10:30
10:30 11:15
Introduction to QRM – QRM Principles
Networking Break
QRM Strategy – What and How (and Link to Culture)
11:15 12:00
QRM Strategy Exercise
12:00 13:00
13:00 13:50
Lunch
Rocco Duran
Risk Management – A Case Study Within an Operations
Supply Site
This presentation will address formalization of risk management
within the site, process enhancements, lifecycle continuous
improvement and control of a potent compound with a low
occupational exposure level (OEL). It will also discuss the
strategic approach to process understanding, control and
containment to further enhance patient and regulatory
requirements.
Mary Zorc
Case Study: Use of Quality Risk Management in the
Assessment and Remediation of Software Quality Systems
Risk Management is an integral part of our lives. The
Regulatory Guidance, e.g., International Conference on
Harmonization, ICH Q9 and International Standards
Organization, ISO14971, are driving to make Quality Risk
Management (QRM) an integral part of our Quality Systems and
daily decision making.
This case study reviews the risk assessment performed on the
implementation of integrated software systems into the
production environment, key remediation activities and lessons
learned.
The study will also discuss the lifecycle (use and maintenance)
of the risk assessment outputs within the Quality System.
13:50 14:40
14:40 15:10
15:10 16:40
Networking Break
QRM in Action – New Facility
Day 1 Recap
17:00
Seminar Adjourns, Reception [Note tomorrow starts at 08:00]
60
15
Keith Gibbs
45
30
Yonkers Industries 45
Keith Gibbs
Yonkers Industries 45
Tim Howard
Jim Lambert
Catherine Acosta
16:40 17:00
Total
min.
John Hannon
Dave Dolgin
Astra Zeneca
60
50
Abbott
50
Commissioning
Agents
30
90
Genentech
Commissioning
Agents
Abbott
20
0
Tuesday, 22 February
Start End Time Presentation Title
Time
7:30 8:00
Breakfast
8:00 8:15
Day 1 Recap & Introduce Day Two
Speaker
Company
John Hannon
8:15
Dave Dolgin
Gregg Claycamp
Commissioning
Agents
Abbott
FDA
Todd Jacobsen
Cook Pharmica
9:00
9:00 10:15
10:15 10:45
10:45 12:00
QRM Review – Regulatory View – When It Goes Right and
When It Goes Wrong
Title
Networking Break
QRM Tools – Interactive Exercise Tool 1
12:00 13:00
13:00 13:45
Total
min.
60
15
45
Keith Gibbs
75
30
Yonkers Industries 75
Lunch
QRM Tools – Interactive Exercise Tool 2
Keith Gibbs
60
Yonkers Industries 45
13:45 14:45
QRM Tools – Interactive Exercise Tool 3
Keith Gibbs
Yonkers Industries 60
14:45 15:15
15:15 16:15
16:15 16:55
16:55 17:00
Networking Break
QRM Case Study – Lifecycle of Organizational QRM
All Speakers
Q&A Panel and Discussion
Up through lunch on Thursday, questions, challenges, concerns
will be solicited using Question Cards provided. Then a panel of
speakers will work through the questions, involving participants
in open discussion to seek solutions.
Close-out
John Hannon
17:00
Seminar Adjourns
Dave Dolgin
Abbott
Commissioning
Agents
Abbott
30
60
40
5
0