Executive Session - Advanced GMP Training

EXECUTIVE SESSION - a cGMP training course
- #FDA #GMP #cGMP #QSR #advanced #training #course

Executive Session is an advanced course that addresses CGMP & QSR issues directly relevant to the executive leadership and executive teams of manufacturers.

Learn more: http://www.skillsplusinc.com/Executive.htm

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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
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GMP Training Ideas - Executive Session

• You might also be interested in FDA CGMP online training courses and programs taught by SkillsPlus International Inc.

Updated August 10, 2024

The "Executive Session" course is no longer available.

Additional online class offerings can be viewed, by following the link above.

---  the original post follows below  ---

483 Observation Gotchas!   1. Firm lacked an effective training program to ensure all employees, including upper management, are fully trained on CGMPs. 2. Management failed to prevent non-controlled documents from being in the dispensing area. 3. Management did not understand their role & responsibility in supporting & enforcing the quality system.            Planning for Training 2014!  2014 is just around the corner!  Can't get management staff to attend your CGMP training sessions, or Not quite sure what to present to management staff for annual CGMP training, or Does management feel that they do not need to attend annual CGMP training? If you answered "Yes" to one or more of these questions, then you need to take a look at our Executive Session 2014 CGMP Update.    Featured Course Executive Session 2014 CGMP Update: This course focuses on what the executive needs to know. There's no discussion of "single-line through ... yada, yada, yada," in this course.   Topics addressed in this intense update: 1. Annual observation update 2. What the observations mean to executives and managers 3. Consequences 4. Interesting court cases 5. Current trends and more!   If your firm needs to get some of your executives and managers into meaningful CGMP training, then you need to look into our Executive Session 2014 CGMP Update!   Return Home: The Health, Drug, Prescription, and GMP Supersite Blog SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors SkillsPlus Intl Info Blog The Exemptee Institute The Designated Representative Institute The Health, Drug, Prescription, and GMP Supersite Gift Store

DOJ - Compliance - Ask Yourself These 5 Questions

• FDA GMP QSR cGMP Online Training - trusted GMP online training classes offered by SkillsPlus International Inc.

The article below challenges you to think about your people and compliance in the form of 5 questions.

Five Compliance Questions to Ask Yourself, from the DOJ:

"the US Justice Department (DOJ) – in the name of “protecting consumers where they are most vulnerable,” according to Frimpong – is also placing a “focus on people,” since processes and policies (at least publicly-circulated processes and policies) don’t typically break the law; people do. “We know there are enormous cost pressures, but you can’t sacrifice safety under these pressures,” said Frimpong.

To that end, Frimpong recommended that attendees ask themselves five questions about the group of people they work with, to help identify potential problems before they result in an investigation or worse."

'via Blog this'

You might also be interested in:

Executive Session: What Leadership Needs to Know - an on-site course
Management Session: What Every Manager Needs to Know - an on-site course

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

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Looking Ahead to Pharma 2010 - Through the IBM innovation lens

Image via Wikipedia

2010 is approaching fast. This is the time of year I start watching out for crystal ball predictions of what's in store for us. For example, check out IBM's vision for 2010, Pharma 2010: The Threshold of Innovation (pdf). 

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FDA Quality by Design - QbD - Executive Guide (pdf)

According to Cerulean Associates' Why Quality by Design? - An Executive's Guide to the FDA's Quality by Design (pdf), "Quality by Design is one of the most misunderstood and misused tools available to biopharmaceutical and medical device executives." The guide is easily understood and closes by driving to a 7-step QbD start-up plan. According to the guide, "the best way to assess how to implement QbD in your organization without making the same mistakes that other companies have made is to utilize a simple 7 step process."

Here's to hoping you enjoy and find this guide a good read, as I found it.

Related Posts:
Quality by Design (QbD) For Analytical Methods (video)

#FDA #GMP #training #cGMP

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