Tuesday, February 25, 2014

Monday, February 24, 2014

Analytical Procedures and Methods Validation for Drugs and Biologics - New FDA Draft Guidance

FDA Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics - DRAFT GUIDANCE (February 2014 - PDF):

"This revised draft guidance supersedes the 2000 draft guidance for industry on Analytical Procedures and Methods Validation and, when finalized, will also replace the 1987 FDA guidance for industry on Submitting Samples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:


Return to SkillsPlus International Info Blog - Home

GMP Trainer Certification - May 5-9, 2014 Public Seminar in Fort Lauderdale, FL
SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around
SkillsPlus Intl Inc. - Sign-up for our announcements via Constant Contact
Enhanced by Zemanta

Friday, February 14, 2014

Certified Designated Representative

 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 - Available for iPad
The Designated Representative Institute

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

SkillsPlus Intl Info Blog

Enhanced by Zemanta

Wednesday, February 12, 2014

Thursday, February 6, 2014

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
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.

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around
SkillsPlus Intl Inc. - Sign-up for our announcements via Constant Contact
Enhanced by Zemanta

Wednesday, February 5, 2014

Do You Have SOP Compliance Problems? Need Help?

#FDA #GMP #cGMP #QSR #training #course
  • 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.

Allan Dewes
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.

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around
SkillsPlus Intl Inc. - Sign-up for our announcements via Constant Contact

Enhanced by Zemanta