Executive Session - An Advanced GMP Training Course

• FDA cGMP QSR GMP Training - online training courses taught by SkillsPlus International Inc.

Updated July 30, 2024

Sadly, "Executive Session" is no longer available.

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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.

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SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

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Analytical Procedures and Methods Validation for Drugs and Biologics - New FDA Draft Guidance

• Recommended FDA GMP online training programs and courses by SkillsPlus International Inc.

Updated September 6, 2022

Here's the latest version of the guidance:

Analytical Procedures and Methods Validation for Drugs and Biologics - Guidance for Industry - FDA.gov

---  the original post follows below  ---

FDA Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics - DRAFT GUIDANCE (February 2014 - PDF):

"This revised draft guidance supersedes the 2000 draft guidance for industry on Analytical Procedures and Methods Validation and, when finalized, will also replace the 1987 FDA guidance for industry on Submitting Samples and Analytical Data for Methods Validation. It provides recommendations on how you, the applicant, can submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products. It will help you assemble information and present data to support your analytical methodologies."

Source:

• Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics (PDF - 359KB)

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SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Root Cause Investigations Workshop - GMP Training

ROOT CAUSE INVESTIGATIONS WORKSHOP
#FDA #GMP #QSR #cGMP #training #course #class

Learn how to dig deeper and discover what's really below the surface. In this course, students apply root cause analysis tools to real in-plant deviations.

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

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SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Certified Designated Representative

Florida Certified Designated Representative (CDR)

 CERTIFIED DESIGNATED REPRESENTATIVE
"All prescription drug wholesale distributor and out-of-state prescription drug wholesale distributor permittees and applicants must designate in writing at least one natural person to serve as the designated representative for a given establishment.  Such person must have an active certification from the department (a “certified designated representative” or “CDR”)." [Source: Florida Certified Designated Representative: - 'via Blog this']

Go to:  The Designated Representative and Exemptee Blog

FL Certified Designated Representative online e-Learning exam preparation by SkillsPlus Intl Inc.
CA Designated Representative online web-based training certification by SkillsPlus Intl Inc - Available around-the-clock 24 x 7 
The Designated Representative Institute

CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc 
The Exemptee Institute

SkillsPlus Intl Info Blog

FDA Orange Book 2014 - 34th Edition

The 2014 FDA Orange Book (34th Edition) is hot off the press.

This 34th edition of the FDA Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is current through December 31, 2013.

View the Orange Book:
FDA Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) - PDF

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Tired Of Boring Training? Then Feel The Thrill of the GMP Olympics!

#FDA #GMP #QSR #cGMP #training #course #class

• Do your employees avoid CGMP training, claiming they've heard it all? 
• Do they resist attending CGMP training because "their" job is never discussed? 
• Do some employees "drift off" in CGMP training because it is too theoretical? 

If you answered "Yes" to any of these questions, then you need to take a look at our GMP Olympics Refresher course.

Featured Course: GMP Olympics 
Participate in the Olympics! This course challenges even the most seasoned employee's knowledge of CGMPs. This course is definitely not for employees who are new to the industry.

Activities from this highly interactive workshop include:

• Heard on the Street 
• Team-based regulation review 
• GMP Challenge 
• Inspection Detection, and more! 

This course can be customized to meet a variety of content and time constraints.

Learn more: GMP Olympics – Course Outline

Allan Dewes, President. About Your Instructor Allan Dewes    Allan Dewes has been training employees for over 40 years, with 30 years in the pharmaceutical industry. Allan understands CGMP regulations, the FDA expectations, and how to make training fun to maximize retention. Email today to request a quotation

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Do You Have SOP Compliance Problems? Need Help?

Updated 12/26/2022

The original post got outdated.

You might also be interested in:

FDA cGMP online training courses by SkillsPlus International Inc.

---  the original post follows below  ---

• Do CGMP documents contain many errors, or
• Are change controls often side-stepped, or 
• Is the Quality Unit often side-stepped, or 
• Are procedures not always followed?

If you answered "Yes" to any of these questions, then take a look at our Qualstar: A CGMP Training Simulation course.

Featured Course:   Qualstar - A CGMP Simulation
Designed to teach and to change the culture of companies in order to focus on quality and compliance. This competitive simulation is an eye-opener for participant and executive staff observers alike. Issues addressed in this exciting simulation:

1. Documentation problems
2. Procedures not being followed
3. Change control not practiced
4. QA not consulted on deviations 

If this describes some of your issues, then you need to experience Qualstar!
Examine The Qualstar Outline

Ready? Set? Go! and feel the high energy of this popular and exciting course.

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SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

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