Thursday, January 16, 2014

GMP Training Needs To Be Conducted By Trained & Qualified Individuals

English: Training Fran├žais : Formation
English: Training Fran├žais : Formation (Photo credit: Wikipedia)
Act now to avoid these common deficiencies:
  • Failure to ensure that each person has the education, training and experience to perform their assigned functions
  • Failure to document that all personnel are trained to adequately perform their assigned responsibilities
Food For Thought On GMP Trainers:
  • cGMP trainers should be trained and qualified instructors who have the required background and experience in the subject matter. 
  • Be aware that when “repeated” errors are noted in documents, inspectors will look at training records to see if the trainers have been trained. 
  • One documentation approach is to keep resumes of all trainers on file permanently, so that they are available for FDA inspection. 
What Now?:
Useful References:

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Wednesday, January 15, 2014

Training For GMP Trainers - Commit To Excellence

Public Seminar Location: Pelican Grand Beach Resort
New Year's Day has come and gone. If your new year resolution included a commitment to professional development, then act now to sign-up for this popular public seminar workshop.

GMP Trainer Certification Workshop - May 5-9, 2014 Public Seminar - Fort Lauderdale, FL

Early Bird Special - Save $600 - Limited Time Offer
Learn more:   GMP Trainer Certification Workshop - May 5-9, 2014 Public Seminar - Fort Lauderdale, FL

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Monday, January 6, 2014

About Training for GMP Trainers - Enhance Your Skills

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

If you think you or a member of your team needs help in developing training skills, then consider attending our May 5-9, 2014 GMP Trainer Certification Public Seminar in Fort Lauderdale, FL.
GMP-QSR Trainer Certification Public Seminar by SkillsPlus International Inc.
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SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around
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