GMP Mini-Series


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GMP Mini-Series

This product has been discontinued.

How To Use These Materials - Today, many trainers are developing their own e-learning courses and PowerPoint presentations. Developing collateral material to make these programs interesting is very time-consuming. Program developers don't often have the time to develop such materials for the courses needed. SkillsPlus has developed these video resources which can be plugged into PowerPoint presentations, added to e-learning courses, or uploaded to learning management systems. The instructional designer determines the key learning points to highlight in the first questions to evaluate attention. These short segments, six to 10 minutes, are designed to entertain and reinforce a simple key learning message. Available in these file formats: WMV, SWF, FLV, or AVI. 

Buy Now - "GMP Mini-Series: Documentation Problems" (movie version $275) -  E-Learning Download

Licensing Limitations - Your license permits you unlimited use of these materials within your plant site. Call us if you need a global license. The use of these materials in consultant contracted services or the use of these materials in other for-sale-products is strictly prohibited. Consultants and training material developers developing materials for resale must call for special arrangements.

Overcoming Documentation Problems in the Pharmaceutical Industry
A five part video mini-series. Watch these free preview clips! (click the hyperlinks below). 

Part 1 - Plain and Simple - In the first segment titled "Plain and Simple," the student explores common documentation problems experienced in many pharmaceutical companies. David Wiley, playing the role of an FDA inspector clarifies how the FDA interprets such documentation problems. Barbara Atwater, Vice-President of Quality for Qualstar Pharmaceutical reinforces the importance of following procedures.

Part 2 - It's Happening All The Time Around Here - In the second segment titled "It's Happening All The Time Around Here," David Wiley explores additional unacceptable documentation practices found in a variety of different records in the pharmaceutical industry. The focus of David's comments in this section is blank spaces in documents. Barbara clarifies the proper technique for handling blank spaces in records.

Part 3 - What's In Your Hand? - In the third segment titled "What's In Your Hand?" David Wiley clarifies the expectations of the FDA with regard to capturing information in control documents. In this segment Barbara identifies several reasons for failing to properly document employees work.

Part 4 - Correcting Those Errors - In the fourth segment titled "Correcting Those Errors," David Wiley identifies several unacceptable error correction practices in the pharmaceutical industry. In this segment Barbara clarifies the rules as applied at Qualstar Pharmaceutical for correcting errors in documents.

Part 5 - Out The Gate Before You're Eight - In the fifth segment titled "Out The Gate Before You're Eight," David Wiley discusses the concerns the FDA has when they discover falsified information and documents. Barbara clarifies the Qualstar practice, and common industry consequences for falsification and records.

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