Friday, April 12, 2013

Root Cause Analysis for Better Deviation Investigations - Onsite Courses - Popular

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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Monday, April 8, 2013

How To Become A Better GMP Trainer

Trainers must be skilled!
  • They must be expert course designers and facilitators
  • They must pay attention to the experiential learning process
  • They must keep students involved, engaged, and energized
It’s a given that GMP & QSR trainers must have mastery over the regulations that they are teaching. Mastering applicable laws, regulations, directives, standards, guidance, and compendia for manufacturing biologics, drugs, dietary supplements, and medical devices is essential for raising your company’s employees and management team compliance competency.

GMP & QSR trainers must also be able to help others expand their knowledge of relevant regulatory requirements, and to help others apply that knowledge in the workplace.

What does that mean?
It means that trainers must have the skills needed to teach others. We often find that trainers, program designers, training supervisors, training managers, and others who conduct GMP or QSR training in the pharmaceutical, biotech, medical device or dietary supplement industries need help in developing their training skills.

Expert GMP & QSR trainers:
  1. Focus on experiential learning processes
  2. Teach in a facilitation and learning style that’s appropriate to particular regulatory topics
  3. Design and facilitate learning activities
  4. Facilitate meaningful discussions, and create safe environments through the debrief process
  5. Model different teaching strategies
  6. Tell compelling case stories
  7. Keep students involved, engaged, and energized

11/21/13 Update:
Attend our May 5-9, 2014 GMP Trainer Certification Public Seminar in Fort Lauderdale, FL. Learn more: http://www.skillsplusinc.com/Pub_Sem.htm

If you think you or a member of your team needs help in developing training skills, then consider attending our only 2013 offering of this course, on May 6-10th:
 GMP-QSR Trainer Certification Public Seminar by SkillsPlus International Inc.
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