Thursday, March 29, 2012

Posters! cGMP Posters! QSR Posters! Lots of them!

Beautiful. High-quality. Great compliance messages. Buy one or buy them all. Display these posters in common areas. Reinforce key compliance messages by reminding employees on the importance of maintaining a regulatory compliant lifestyle for product quality assurance and good business practice.

cGMP & QSR Motivational Posters - by SkillsPlus International Inc.
Created by the well-known San Francisco artist Francis Redman, attracts attention and reinforces the message.

For more information, look at the SkillsPlus cGMP and QSR Posters on CD Catalog

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Monday, March 26, 2012

Olympics for Medical Device Manufacturers - Onsite QSR Training Class

This class gets students engaged, energized, and so excited that they'll be up out of their seats!

Olympics for Medical Device Manufacturers - Onsite QSR Training by SkillsPlus International Inc.

This course takes QSRs to a deeper level of understanding through a series of challenging activities. Past students would say this training is fun!  This instructor led class is taught on-site in-house at client plant locations.

By the end of class, students will be able to:
1. List the hottest issues in QSR compliance.
2. Locate items of interest in 21CFR820.
3. Explain the 21CFR211 rationale for specific 483 observations.
4. Demonstrate knowledge of common CGMP practices and details.
5. State the consequences of not following QSR.

For more information, visit:
Olympics for Medical Device Manufacturers - Onsite QSR Training by SkillsPlus International Inc.

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Wednesday, March 21, 2012

Onsite cGMP Training - Olympics for Pharmaceutical & Biotech Manufacturers

Onsite cGMP Training -  Olympics for Pharmaceutical & Biotech Manufacturers - by SkillsPlus International Inc.

How many boring training classes have you and your colleagues been through?!

Say NO to boring training. Experience exciting, energizing, and engaging training!

Take a deep dive to a deeper level of understanding through a series of challenging activities.

By the end of this class, energized students will be able to:
1. List the hottest issues in CGMP compliance.
2. Locate items of interest in 21CFR211.
3. Explain the 21CFR211 rationale for specific 483 observations.
4. Demonstrate knowledge of common CGMP practices and details.
5. State the consequences of not following CGMPs.

For more information, visit:
Olympics for Pharmaceutical & Biotech Manufacturers - by SkillsPlus International Inc.

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Tuesday, March 20, 2012

Management Session: What Every Manager Needs to Know - Onsite GMP & QSR Training

Management Session: What Every Manager Needs to Know - is a live onsite GMP & QSR training class by SkillsPlus International Inc.   This is an instructor led course, taught on-site in-house in-plant at the locations of your choice.

Know your stuff and lead with confidence!

This course addresses CGMP and QSR issues directly relevant to the executive leadership and executive teams of manufacturers.

Upon completion of this class, you'll be able to:
1. State the common 483 observations issued by the FDA.
2. List the basic requirements of CGMP or QSRs that require the attention of the leadership team.
3. Identify gaps in compliance.
4. Identify the issues that needs to be rectified.

For more information, visit:
Management Session: What Every Manager Needs to Know - training by SkillsPlus International Inc.

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Wednesday, March 14, 2012

ISO 17025: Calibration Laboratories - Onsite Training Class

If you need to understand the expectations of a metrology lab from the global perspective, and not just from the US perspective, then you need this course:

 ISO 17025: Calibration Laboratories - live on-site training by SkillsPlus International Inc.

In this class, you'll learn the details of ISO 17025 as it relates to calibration laboratories. This class is instructor-led, and taught on-site in-plant, at client locations.

Upon class completion, students will be able to:
  1. Explain the rationale for ISO 17025. 
  2. Explain the management requirements from a regulatory perspective. 
  3. Explain the technical requirements from a regulatory perspective.
For more information, and to view a list of the topics covered, visit:

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Monday, March 12, 2012

Using Video In The Classroom - Free GMP and QSR Training Tip

Scan of a DVD 4.5 capacity disk
Image via Wikipedia
Using videos and DVDs in the classroom isn't difficult. And they're 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 SkillsPlus Intl Inc. movies and interactive CBTs 
  4. After the DVD is over, follow up on what the class has learned. Using the round robin technique, chart everybody's responses. As an instructor, elaborate on the class response as appropriate.
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Wednesday, March 7, 2012

Human Errors: Overcoming the Challenges - Onsite cGMP & QSR training

Human Errors: Overcoming the Challenges - live on-site cGMP & QSR training by SkillsPlus International Inc.

Humans make errors, AND, more likely, there are processes and systems that are root causes of setting people up to fail.

Purpose:
This class teaches how to overcome human errors as a root cause to deviations.

Objectives:  upon class completion, students will be able to . . .
1. State what the CGMPs imply regarding human errors.
2. State the FDA's current thinking about human errors and deviations.
3. Describe the basics of root cause determination.
4. List the possible root causes to human errors.

Topics Covered:
  • Overview of 483 observations
  • Psychology of human failures
  • Investigating human errors
  • Preventing human errors

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Monday, March 5, 2012

Executive Session: What Leadership Needs to Know - Onsite cGMP & QSR training

Executive Session: What Leadership Needs to Know - live onsite cGMP & QSR training by SkillsPlus International Inc.

Executives and top leadership teams need to be knowledgeable, in order to lead the troops!

Purpose:
Addresses CGMP and QSR issues directly relevant to the executive leadership and executive teams of manufacturers.

Objectives:   upon class completion, leaders will be able to . . .
1. State the common 483 observations issued by the FDA.
2. List the basic requirements of CGMP or QSRs that require the attention of the leadership team.
3. Identify gaps in compliance.
4. Identify the issues that needs to be rectified.

For more information, visit:
Executive Session: What Leadership Needs to Know - live onsite cGMP & QSR training by SkillsPlus International Inc.

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Thursday, March 1, 2012

Essentials for Pharmaceutical Manufacturers - Live onsite cGMP training

Essentials for Pharmaceutical Manufacturers is a SkillsPlus International Inc. course - it's a live onsite cGMP training class taught on-site, in-house, at client plant locations.

It's the perfect introductory class for employees new to the pharma-biotech industry, and also serves as a wonderful refresher course for staff needing continuing education.

By the end of this engaging interactive class, students will be able to:
1. State the historical development of CGMP regulations.
2. Explain the role and function of standard operating procedures.
3. Describe the personal role for contamination control.
4. Identify the sources of contamination.
. . . and much more!

For more information, go to:
Essentials for Pharmaceutical Manufacturers is a SkillsPlus International Inc. course

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