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About
the Workshops
| Who
Should Attend |
Program Details | Workshop
Leader
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Hotel and Registration
Information | Half-Day
Registration Form (pdf) | Full-Day
Registration Form (pdf)
|
Half-Day
Excipient GMP Auditing Workshop
Monday, February 28, 2005
8:00
am - 8:30 am Check in and Registration
8:30 am - 12:00 WORKSHOP SESSION
Program
Details
- Course
Overview
o
Review
Course Agenda
o
Introductions
- Uniqueness
of Excipient Manufacture and Use
o
Excipient
Manufacturers
o Manufacturing Processes
o Scale of Manufacture
o Characterization
o Excipient and Other Applications
o Where Does GMP Start?
- Assessing
Excipient GMP
o
Questionnaire
o
Second
Party Audit
o
Third
Party Audit
- Performing
an Excipient Audit
o
Audit
SOP
o
Audit
Preparation
o
Audit
Techniques
o
Audit
Report
- Excipient
GMP Compliance Requirements
o
Review
of Key Sections of Excipient GMPs
- Common
Site Deficiencies
|
***
Workshop space limited to the first 30
registrants***
|
Full-Day
Excipient GMP Auditing Workshop
Monday,
February 28, 2005
8:00
am - 8:30 am Check in and Registration
8:30 am - 4:30 pm WORKSHOP SESSION
Program
Details
- Course
Overview
o
Review
Course Agenda
o
Introductions
o
Participant
Expectations
o
Review
of Course Materials
- Uniqueness
of Excipient Manufacture and Use
o
Excipient
Manufacturers
o
Manufacturing
Processes
o
Scale
of Manufacture
o
Characterization
o
Excipient and Other Applications
o
Where
Does GMP Start?
- Excipient
GMP Compliance
o
Regulatory Status
o
IPEC
Excipient GMPs
o
Comparison
of Excipient GMP to ISO 9001 Quality Standard
o
Comparison
of Excipient GMP to API Q7a
o
Comparison of Excipient GMP to Part 211
o
Application
of Excipient GMP to Distributors
o
Assessing
a Manufacturer Compliant with Food GMP
- Assessing
Excipient GMP
o
Assessing
GMP Compliance
o
Questionnaire
o
Second
Party Audit
o
Third
Party Audit
o
Food
Ingredient Manufacturers
- Excipient
Manufacturer GMP Audit
o
Scope
of the Audit
o
Purpose
of the Audit
o
Safety
Considerations
o
Audit
Plan
o
Audit
Preparation
o
General
Auditing Considerations
o
Risk
Based Auditing
- Excipient
Audit Expectations
o
Common
Deficiencies
o
Basic
SOPs
o
Equipment
Qualification
o
Validation
o
Change
Management and Significant Change Notification
- Compliance
Considerations
o
Top
Ten GMP Compliance List
o
Risk
of Contamination
o
Excipient COA
o
Alternate Methods of Assessing GMP Compliance
- IPEA
Audit Program
o
Program
Overview
o
Benefits
Registration
Fees
Employees
of IPEC-Americas Member Companies
Nonmembers
Government/Academic
|
|
Half-Day
$ 250.00
$
350.00
$
50.00
|
Full-Day
$ 450.00
$
550.00
$
50.00
|
|
Credit
cards not accepted. Check payment must
accompany
registration form for processing.
*** Workshop is limited to the first 30
registrants***
|
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Here to Go Back to Workshop Homepage
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