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Free CGMP Training Ideas, Tips and Other CGMP Related Stuff
By SkillsPlus International

Welcome to the SkillsPlus Free Tips page. This page provides free training tips and other useful information for trainers and compliance professionals.

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How to Calculate Combined Uncertainty - Posted 11/20/2009 I found this to be a great link for understanding this issue especially as it relates to ISO 17025. Click

How to Understand Tolerance versus Uncertainty - Posted 11/20/2009 I found this to be a great link for understanding these issues especially as it relates to ISO 17025. Click

Where Can I find a Reference to Error Correction Procedures? - Posted 11/20/2009

Great question. One such source is ISO 17025, Page 9 4.13.2.3. "When mistakes occur in records, each mistake shall be crossed out, not erased, made illegible or deleted, and the correct value entered alongside. All such alterations to records shall be signed or initialed by the person making the correction. In the case of records stored electronically, equivalent measures shall be taken to avoid loss or change of original data."

Using Video and DVDs in the Classroom - Posted 11/5/2009

Using videos and DVDs in the classroom is not difficult. But it is not intended to be a babysitter while the instructor gets a cup of coffee. Successfully using videos and DVDs in the classroom requires four simple steps, three of which are often forgotten, and a qualified instructor.

1. Tell the class what they are going to see and why you want them to see it.

2. Give the class an assignment to perform during and immediately after the video or DVD has ended. The assignment can be as simple as, "During this DVD write down as many things you did not know prior to watching this DVD."

3. Now it's time to turn on the DVD. See our list of movies and interactive CBTs

4. After the DVD is over, follow up on what the class has learned. Using the round robin technique, chart everyone's responses. As an instructor elaborate on the class response as appropriate.

Overcoming Documentation Errors - Posted 7/23/2009

Documentation errors that are not corrected at the time they are made, cost drug and device manufacturers thousands of dollars each year in deviation investigations and delayed shipment of products. Documentation training frequently fails to keep the important documentation training message at the forefront of each person's thinking.

Training Suggestion

Shortly before training, and for some time after training, posters, used like safety signs, can help reinforce, remind and keep the message repetitive.

Tips for using posters in your plant

1. Put them up about 1-2 weeks before a planned training session.
2. Reference them in the training and link them to the compliance message.

3. After the training, display the posters at difference locations around the plant. Each poster should have a separate slogan or reminder to attract attention.