Friday, June 28, 2013

Stop Blaming The Same Old "False" Root Causes

Pinpointing the wrong cause (for example, a "false" root cause) can result in ineffective immediate, corrective, and preventive actions.
  • Throwing fixes at the wrong things might not fix the problem.
  • Blaming and overusing human error as the root cause can result in incomplete and ineffective root cause analysis.
By taking our courses, you'll more confidently identify the real root causes, and craft clearer and more concise investigation reports.

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These highly popular cGMP & QSR training classes are taught at the location of your choice, as a client on-site in-house training. You might be interested in two of our highly inter-related courses.
  1. Root Cause Analysis for Better Investigations, and
  2. Deviation Investigation Reports
- - - FIRST - - -

Root Cause Analysis for Better Deviation Investigations: On-site Training by SkillsPlus International Inc.:
"Purpose:
  • To conduct or facilitate an individual or team-based investigation that solves problems and gets results, and complies with FDA expectations in the pharmaceutical and biotech industries. 
Objectives
1. Use tools and techniques to effectively identify the deviation statement.
2. Identify the root cause of the deviation.
3. Generate and objectively select the best corrective and preventive actions.
4. Assess the risk of implementing the corrective action and preventive action.
5. Develop a contingency plan to preventive action implementation.
6. Create corrective actions and preventive action metrics. 
About the Class
1. This class uses current deviations to practice the techniques taught.
2. The optional final exam is approximately 25 questions.
3. Each student receives a student guide containing a representation of the program's
slides and graphics with space provided for note taking.
4. This class can accommodate up to 25 people.
5. Duration: 8 hours."
'via Blog this'

- - - SECOND - - -

Deviation Investigation Reports: On-Site Training by SkillsPlus International Inc.:

Purpose:
  • To use the data collected in an investigation to write a report and answer management and FDA questions.
 Objectives 
  1. Increase investigation report suitability for FDA review. 
  2. Decrease the number of reports returned by internal reviewers. 
  3. Write supported deviation statements. 
  4. Provide a detailed background statement to include related information, investigations, affected materials and references. 
  5. Document deviation investigation findings. 
  6. State the root cause with supporting facts. 
  7. Generate supported, plausible, and defensible corrective actions. 
  8. Develop effectiveness measures for the corrective actions. 
  9. Generate realistic preventive actions. 
  10. Develop effectiveness measures for the preventive actions. 
  11. Develop a follow up plan for corrective and preventive actions. 
  12. Write accurate executive summary statements. 
 About the Class
  1. In-house deviation reports will be used to demonstrate and practice the skills and principles of this class.
  2. This course is best taught in a computer lab. We can ship computer labs to your site if needed.
  3. This course is customized to reflect your company procedure on writing deviation investigation reports. As we review that document we will make any recommendations to for change that we feel would be helpful.
  4. The optional final exam is approximately 25 questions.
  5. Each student receives a student guide containing a representation of the program's  slides and graphics with space provided for note taking.
  6. This class can accommodate up to 12 people.
  7. Duration: 8 hours as a minimum.
For more information:

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Tuesday, June 25, 2013

Friday, June 21, 2013

FDA Gets EC Waiver To Export APIs

Press Announcements > FDA obtains waiver from European Commission to facilitate export for U.S. pharmaceutical manufacturers:

" . . . the U.S. is now a “listed” country with the European Commission (EC) so that U.S. companies need not obtain an export certificate from the FDA before shipping certain pharmaceutical products to Europe.

Without the waiver, all U.S. companies shipping active pharmaceutical ingredients (APIs) to Europe after July 1, 2013 would have had to first submit documentation from the FDA that the product was manufactured in accordance with Europe’s good manufacturing practices."

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Monday, June 17, 2013

FDA - Hurricane Preparedness Free Tips

Be safe, be prepared. Follow the link below to the FDA's tips on hurricane preparedness.

Public Health Focus > Hurricane Safety Checklist:

"The FDA reminds consumers to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves, their families, and their pets during and after any hurricane-related rain, possible flooding and power outages.

The agency also reminds consumers that it is important to have a plan in place for emergency medication and medical supplies for both people and animals. This is especially true for those with health concerns, particularly if the power goes out.

In general, FDA encourages consumers to: . . . "

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