Friday
Aug272010
For direct download
(HTML/Flash)
(HTML/Flash)
For import into LMS
(SCORM 1.2)
(SCORM 1.2)
For import into LMS
(SCORM 2004 3rd Edition)
(SCORM 2004 3rd Edition)
For import into LMS
(AICC)
(AICC)
;)
Click image to view larger
Risk Analysis: Using a Simple Tool for Powerful Results
| Price: | $295 |
| Delivery: | Immediate (Electronic Download) |
| Format: | ZIP archive |
Course Outline:
- FDA thoughts on risk management
- Risk analysis tool
- How to calculate the risk index
- How to use the risk index
- Unacceptable, undesirable, marginal, and acceptable risks
- An example of using the risk analysis tool
- Lessons learned
- Knowledge assessment
Course Length:
13 minutes plus the time to take the Knowledge Assessment
Who Should Take This Course:
Supervisory, management and executive personnel, especially those with responsibility for conducting risk management activities
Flexible Delivery:
This course can be delivered to a group in a classroom setting, or online to individuals.
Special Features:
- Step-by-step instructions clearly explain the use of the risk analysis tool
- Narration frees trainer from time-consuming preparation (narration can be optionally muted if trainer wants to deliver personally)
- Periodic, interactive review questions
- A case study example for clarification
- Knowledge assessment for documented evidence of program understanding
For direct download
(HTML/Flash)
(HTML/Flash)
For import into LMS
(SCORM 1.2)
(SCORM 1.2)
For import into LMS
(SCORM 2004 3rd Edition)
(SCORM 2004 3rd Edition)
For import into LMS
(AICC)
(AICC)
;)
Click image to view larger
An Overview of the FDA Pharmaceutical GMP Regulations
| Price: | $795 |
| Delivery: | Immediate (Electronic Download) |
| Format: | ZIP archive |
Course Outline
- History of US pharmaceutical regulation
- What regulations are there?
- Current "GXP" regulations
- 21 CFR 210
- 21 CFR 211
- Subpart A - General Provisions
- Subpart B - Organization and Personnel
- Subpart C - Buildings and Facilities
- Subpart D - Equipment
- Subpart E - Control of Components, Containers and Closures
- Subpart F - Production and Process Controls
- Subpart G - Packaging and Labeling Control
- Subpart H - Holding and Distribution
- Subpart I - Laboratory Controls
- Subpart J - Records and Reports
- Subpart K - Returned and Salvaged Drug Products
- Where does your job fit in?
- Summary
- Knowledge assessment
Course Length:
30 minutes plus the time to take the Knowledge Assessment
Who Should Take This Course:
New employees as an introduction to the GMP Regulations, and veteran employees to meet the on-going GMP training requirement
Flexible Delivery:
This course can be delivered to a group in a classroom setting, or online to individuals.
Special Features:
- Interactive section "Where does your job fit in?" branches to common pharmaceutical departments and discusses which GMP requirements must be met for those functions - especially valuable for new employees
- Narration frees trainer from time-consuming preparation (narration can be optionally muted if trainer wants to deliver personally)
- Periodic, interactive review questions
- Participatory learning where trainees click on topics for more information
- Knowledge assessment for documented evidence of program understanding
Reader Comments