Event:
TAMPA 2010 CONFERENCE
Inspection Readiness Workshop: From Site Preparation to Successful Execution
Session:
(E02)
Session Leader: Rebecca Waterbury, Phil Russ
Dates:
22-23 February 2010
Location:
Tampa, FL
*Accurate as of 01/27/10*
Monday, 22 February
Start
Time
7:30
9:00
9:15
End Time
9:00
9:15
9:45
Presentation Title
Breakfast
Welcome & Introduction
Understanding The Focus of an Inspection - Submission Documents, Regulatory
Requirements, Jurisdiction, etc.
9:45
10:15
10:45
11:15
12:00
13:00
10:15
10:45
11:15
12:00
13:00
14:30
Quality System Gap Assessments for Inspection Preparation
Networking Break
Quality System Gap Assessments for Inspection Preparation, Cont
Inspection Logistics- Essential Elements for Inspection Planning and Execution
Lunch
General Site Preparations - Managerial & Executive Support, Site Tours, Technical
Demonstrations
14:30
15:00
15:00
15:30
Networking Break
Special Considerations for Laboratories - Methods Validation, Equipment, Chemical
Storage & Control, etc.
15:30
16:30
16:45
17:00
16:30
16:45
17:00
Special Considerations for Computer Systems
Recap of Day 1
Q&A session
Seminar Adjourns, Reception
Speaker
Waterbury
Waterbury
Bowen
Russ
Russ
All
Waterbury
Russ
Snyder
Snyder
All
All
Tuesday, 23 February
Start
Time
7:30
9:00
End Time Presentation Title
Speaker
9:00
Breakfast
10:00
Special Consideration for Equipment - Explaining Calibration and Project Management, Russ
Equipment Criticality and Labeling, Equipment Qualification, Drawings
Bowen
10:00
10:30
10:30
12:00
Networking Break
Preparing Employees for an Inspection - Operator and Supervisor Training, Basic
Interview Skills
All
12:00
13:00
13:00
14:30
Lunch
Preparing Employees for an Inspection - Subject Matter Expert Training, Advanced
Interview Skills
All
14:30
15:00
16:15
17:00
15:00
16:15
17:00
Networking Break
Preparing Employee for an Inspection, Cont.
Q&A Session / Roundtable Discussions
Seminar Adjourns, Reception
All
All
Notice for Agenda
**Please note this class is highly interactive. Course materials include
interactive discussions, worksheets, skits, role playing, practice
interviews, etc. Also, note that agendas are subject to change