Wednesday, March 19, 2014

FDA Reduces GMP Inspections by 40 Percent, Focuses on Imports - PharmaManufacturing

FDA Reduces GMP Inspections by 40 Percent, Focuses on Imports - PharmaManufacturing:

"The FDA plans to conduct 591 domestic good manufacturing practice (GMP) inspections in fiscal 2014 and 2015, down from the 967 performed last year. The agency in turn hopes to perform 30 percent more foreign GMP inspections, conducting 843 inspections each year, up from last year’s 604. Companies will be chosen for inspection based on the agency’s risk-based inspection model that grants leeway to high-quality companies. The FDA takes into account risk factors including Class I recalls and adverse events, as well as compliance history, in applying the risk-based inspections model to its decision making."

'via Blog this'

You might also be interested in:
GMP Trainer Certification Workshop - May 5-9, 2014 Public Seminar - Fort Lauderdale, FL
Surviving An FDA Inspection - a GMP Training Course

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Friday, March 14, 2014

GMP Trainers - Why You Should Get Training

  • It's important to learn the most effective ways to train your employees
  • Never stop learning! Train & be trained as often as possible
  • Your training toolbox should have a ton of things in it. 
"The mediocre teacher tells. The good teacher explains. The superior teacher demonstrates. The great teacher inspires." - William Arthur Ward
Learn more about the GMP Trainer Certification Workshop (by SkillsPlus Intl Inc.), May 5-9, 2014 in sunny South Florida. In this course, you will be actively involved!

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Saturday, March 8, 2014

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
If you think you or a member of your team needs help in developing training skills, then consider attending our only 2014 offering of this course, on May 5-9:
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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