Thursday, November 14, 2013

2014 GMP Training - The cGMP Essentials Course

 
 
483 Observation Gotchas!
 
1. There is no documented training in CGMPs.
2. CGMP training has not been conducted for over three years.
3. Firm lacks qualified CGMP trainers. 
 
 
Planning for Training 2014!

 2014 is just around the corner! 
  1. Do you need to get CGMP and related training completed and do not have the staff, or
  2. Are you and your staff already overloaded, or
  3. Do you just need a new and exciting approach to CGMP training?

    If you answered "Yes" to one or more of these questions, then take a look at our CGMP Essentials course.
 

Featured Course
CGMP Essentials: This course can be structured with more than two dozen different training activities designed to reinforce learning and keep employees engaged. Prior students have high praise. One manager said, "I never knew CGMP training could be so much fun." One former FDA Inspector reported, "I actually learned something."
 
Topics addressed in this very popular course:
1. Heard on the Street
2. Review of 21 CFR 211 Subparts
3. Essential Quality System Tools
4. Consequences for non-compliance, and more!
 
If your firm needs a fresh new look at CGMP training, then you need to look into our CGMP Essentials 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

Monday, November 11, 2013

Recommendations for 2014 GMP Training - Executive Session: What Leadership Needs to Know

 
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! 
  1. Can't get management staff to attend your CGMP training sessions, or
  2. Not quite sure what to present to management staff for annual CGMP training, or
  3. 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.
Learn More About the SkillsPlus Executive Session 2014 CGMP Update Course
  


 
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!

 
Allan Dewes
Allan Dewes, President.
 
About Your Instructor
Allan Dewes

Allan Dewes has been training CGMP for over 30 years, including managers and executives. Allan knows how to adjust his comments and focus on the needs of executives and managers.
 
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

Thursday, November 7, 2013

Dietary Supplement Firms Still Violating Basic Manufacturing Rules - NPI

Dietary Supplement Firms Still Violating Basic Manufacturing Rules - Natural Products Insider:

"FDA has been bringing down the hammer on one out of three dietary supplement firms for failing to comply with cGMPs. Through the first several months of fiscal year 2013, of the 350 cGMP inspections FDA originally designated and concluded as falling under Part 111, the agency's 19 district offices collectively classified 33 percent, or 117 businesses, as OAI (official action indicated)."

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


Ideas For 2014 GMP Training - Deviation Investigation Report Writing Clinic

483 Observation Gotchas!
 
1. Deviation reports failed to include a discussion of product impact.
2. Investigation reports stated this was an isolated incident, yet the database revealed 13 similar incidents.
3. Investigation reports failed to provide data to support the root cause determination
 
 
Planning for Training 2014!

 2014 is just around the corner! 
  1. Do your investigation reports wander all over and never get to the point, or
  2. Do deviation reports fail to document a sound root cause conclusion, or
  3. Do deviation report writers never seem to know what Quality Assurance wants discussed in the report?

    If you answered "Yes" to one or more of these questions, then take a look at our Investigations Report Writing clinic.
 

Featured Course
Deviation Investigation Report Writing Clinic: This course is hands-on and personal. In this clinic, students: learn about each section of your company's investigation report; write each section of the report for a real investigation report, and then; receive personal coaching privately from Allan. This course is not the typical spelling and grammar checking training program often offered.
 
Common sections addressed in this very popular workshop:
1. Deviation Description
2. Previous Related Investigations
3. Product Impact Assessment
4. Root Cause Investigation Discussion
5. Root Cause Determination
6. Risk Assessment
7. Corrective and Preventive Actions and more!
 
If your firm is not satisfied with the quality of deviation investigation reports, then you need to look into our Deviation Investigation Report Writing Clinic!
 

Allan Dewes
Allan Dewes, President.
 
About Your Instructor
Allan Dewes

Allan Dewes has been teaching others to write deviation investigation reports for over 15 years. Allan understands CGMP regulations, the FDA expectations for deviation investigation reports, and how to coach others to write a quality document.
 
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

Tuesday, November 5, 2013

FDA Proposal - Head Off More Drug Shortages

FDA proposal aims to head off more drug shortages:

"The Food and Drug Administration announced a new proposal Thursday to try and head off more shortages of crucial medications that have disrupted care at hospitals and clinics nationwide.

Under the proposed rule, companies that make medically important prescription medicines would have to notify the FDA six months ahead of any changes that could disrupt the U.S. supply. That includes plans to discontinue a product or manufacturing changes that could slow production."

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