| | 2008 Class
Topics
By
SkillsPlus International
Time Zone
Calculator - For other time zones not in the continental US please use this
convenient World Clock Meeting Planner to assess correct start time.
To learn more about a specific class, locate the class in the box below and
click. To speak with the instructor about a class call Jess Ball at (909) 915-7226.
Course
Descriptions
|
New
Employee GMP Orientation Part 1 |
|
Enroll
$750 Per PC Connection |
Sign
In |
Est.
Class
Length 4.0 Hours |
|
Topics:
Target
audience is new employees starting working in pharmaceuticals or medical
devices.
-
The
History of GMPs and the FDA
-
Personal
job responsibilities
-
The
role of procedures and change control
-
Contamination
sources
-
Personal
sanitation and health practices
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Proper
documentation practices
-
Material
handling practices
|
|
New
Employee GMP Orientation Part 2 |
|
Enroll
$750 Fee Per
PC Connection |
Sign
In
|
Est. Class Length
4.0 Hours
|
|
Topics:
Target audience is new employees starting working in pharmaceuticals or
medical devices.
-
Production
and process controls
-
Building
and facilities issues
-
Equipment
and calibration
-
The
role of Quality Assurance
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The
role of Quality Control
-
Packaging
and labeling
|
|
GMP
Annual Refresher |
|
Enroll
$750 Fee Per
PC Connection |
Sign
In
|
Est. Class Length
4.0 Hours
|
|
Topics:
Target audience includes employees with prior GMP training who need a
quick update on important compliance practices and new and emerging issues.
-
21
CFR 211 Review
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2007
483 Citation Trends
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Review
of GMPs for the 21st Century
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Quality
Systems Approach to GMPs
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Key
Learnings from US v. Barr
-
Review
of Deviation Investigation Compliance Issues
-
Review
of Investigation Report Compliance Issues
-
Review
of Procedure Compliance Issues
|
FDA:
Past, Present and Future |
|
Enroll
$500 Fee Per
PC Connection |
Sign
In
|
Est. Class Length
1.0 Hours
|
|
Topics:
Target audience all employees needs a review of the basis for GMPs and
where the regulations are heading in the future.
-
History
of the FDA and GMPs
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The goal of GMPs
-
Growing
influences of the FDA
-
Regulatory
inspection alternatives
-
Legal
consequences of not complying with GMPs
|
Contamination
Control |
|
Enroll
$500 Fee Per
PC Connection |
Sign
In
|
Est. Class Length
1.0 Hours
|
Topics:
Target audience all employees who need to review the requirements of
contamination control to meet new job assignment training or as part of a
preventive action.
-
Sources
of contamination
-
Personal
hygiene
-
Environmental
monitoring
-
Cleaning
-
Documentation
|
Materials |
|
Enroll
$500 Fee Per
PC Connection |
Sign
In
|
Est. Class Length
1.0 Hours
|
|
Topics:
Target audience includes all employees who order, move, process, approve
or reject materials.
Start
Times: Eastern
2:00 PM - Central 1:00 PM - Mountain
12:00 PM - Pacific 11:00 AM |
Packaging
and Labeling |
|
Enroll
$500 Fee Per
PC Connection |
Sign
In
|
Est. Class Length
1.0 Hours
|
|
Topics:
Target audience includes all employees who are responsible for the
handling of packaging and labeling supplies or who package drug products.
-
Packaging
and labeling regulations
-
Sampling
and inspection of labeling
-
Labels
and labeling controls
-
Branding
-
Packaging
and labeling operations
-
Expiration
dating
-
Tamper-evident
packaging
-
Labeling
Documentation
|
Good
Laboratory Practices
for Manufacturing Supporting Laboratories |
|
Enroll
$750 Fee Per
PC Connection |
Sign
In
|
Est. Class Length
4.0 Hours
|
|
Topics:
Target audience all laboratory analysts who need a review of the important
GMP regulations affecting the laboratory.
-
Regulatory
Requirements
-
Laboratory
Organization and Personnel
-
Receipt
of Materials in the Laboratory
-
Sampling
-
Analytical
Methods and Results Review
-
Stability
Testing
-
Reserve
Samples
-
Certificate
of Analysis
-
Laboratory
Documentation
-
Laboratory
Facilities and Equipment
|
- Topic
outline details subject to change without notice based upon the regulatory
environment.
- Class
length and end times are estimates and will vary based on student questions,
discussion, class size, and individual instructor teaching style
- Classes
are intended to be educational and to share common industry practices as
examples of regulatory requirements and are not intended to make legal
recommendations. Please consult your regulatory group or legal counsel prior
to implementing any suggestions offered in class. Your specific situation
may be different.
- Please adjust start times to reflect any unique local
time zones factors such as participating or not
participating in daylight savings time adjustments. There are no refunds for
missed classes.
- In the event of technical difficulties between telephone
systems, Internet, computers or other unforeseen technical problems,
SkillsPlus incurs no liability and its sole responsibility is to reschedule
the class.
- Students who miss a class must re-register paying a new
registration fee.
- There is a re-scheduling fee of $50 with less than
5-days advanced notice.
- Tickets are per PC. You decide how many people per room.
- Contact us for a
prompt reply!
|
Inquiry
|
Telephone
|
Email
|
|
Information via
Email |
(415) 487-3500 |
Click
Here |
|
Corporate and Consulting Services
|
(415) 487-3500
|
skillsplus@aol.com
|
|
Sales: Product and Services
|
(804) 938-4102
|
jackieoneillo@aol.com
|
|
Designated Representative
|
(415) 487-3500
|
skillsplus@aol.com
|
|
Exemptee
Certification
|
(415) 487-3500
|
skillsplus@aol.com
|
|
Fax orders to
|
(415) 487-1926
|
|
|
Webmaster
|
(415) 487-3500
|
skillsplus@aol.com
|
|
Product
and Service Support |
| On-line tech support for CBT classes |
|
Click
Here |
| On-line tech support for on-line purchases |
|
Click
Here |
|
Live computer
based training tech support |
(415) 487-3500 |
Allan |
|
Live GMP Content
questions |
(415) 487-3500 |
Allan, Jackie,
or Jesse |
©2008 SkillsPlus
International Inc.
|
