Showing posts with label plan. Show all posts
Showing posts with label plan. Show all posts

Wednesday, November 11, 2015

Free GMP Training Tips - A Focus On Class Times & More


For optimal throughput, choose class schedules & format wisely.

Coordinate training schedules for maximum gain

Give some thought on how to minimize the impact on production and other critical daily work responsibilities. Unless your production lines are down, you'll want to make sure production quality doesn't suffer. For some, even though they're in class, their minds are elsewhere (distracted by what's waiting for them back at their desks). Try to limit putting extra demands & stress on staff (for example, a stressor such as asking staff to attend class before/after their normal work shift, especially if they work 3rd shift). Here are a few ideas:
  • Split it.  If the course is 8 hours long, split the classroom time in half, and conduct the class over a 2 day period.
  • Deliver training at some time other than regular shift hours (this might be obvious). And be sure to consider offering training on the weekend.

Choose the best format & venue

  • Chunk training into digestible sessions. It's important to create an effective learning experience. For content heavy topics or workshop courses, it might make sense to split it up to avoid full day training overload, and give a little time for homework or just a breather to let it all sink in. 
  • Sometimes you have no choice but to get very larger numbers of employees through training as fast as possible. One possibility is to use a large venue (for example, an auditorium or conference facility) to meet your training goals & objectives, and achieve the necessary training throughput.

Get a trainer that teaches at your desired times

The right training vendor will do their best to accommodate your unique site and staffing situation to deliver training courses at the times that work best for you. For example, explore having the trainer teach a class during 3rd shift or on the weekend.

Do these tips touch on your situation, and you need GMP training?

If you said yes:
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Thursday, October 31, 2013

2014 GMP Training Ideas - GMP Olympics Refresher Course

Updated September 26, 2022

The GMP training course described in the original post is no longer offered.

People also search for:

---  the original post follows below  ---
 
Plan for cGMP Training 2014!

 2014 is just around the corner! 
  1. Do your employees avoid CGMP training, claiming they've heard it all, or
  2. Do they resist attending CGMP training because "their" job is never discussed, or
  3. Do some employees "drift off" in CGMP training because it is too theoretical?

    If you answered "Yes" to one or more of these questions, then you need to take a look at our GMP Olympics Refresher course.
 

 
Featured Course
GMP Olympics 2014: Become a participant in the Olympics! This course challenges even the most seasoned employee's knowledge of CGMPs. This course is definitely not for new employees who are new to the industry.
Activities from this highly interactive workshop:
1. Heard on the Street
2. Team-based regulation review
3. GMP Challenge
4. Inspection Detection, and more!
This course can be customized to meet a variety of content and time constraints.
Examine the GMP Olympics 2014 Course Outline


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.
Email today to request a quotation

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Tuesday, December 4, 2012

2013 Plan For FDA CDRH Guidance Documents

The CDRH is considering developing a variety of guidance documents in fiscal year 2013. Specific topics and status as final and draft guidance document, are provided in the two lists:


Prioritized medical device guidance documents that the Agency intends to publish in FY 2013 ("A-list")


Final Guidance Topics
  • Refuse to Accept (RTA) Policy for 510(k) Submissions
  • Acceptance and Filing Review for Premarket Approval Applications
  • Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies
  • In Vitro Companion Diagnostic Devices
  • Design Considerations for Pivotal Clinical Investigations for Medical Devices
  • De Novo Classification Process (Evaluation of Automatic Class III Designation)
  • The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications
  • CDRH Appeals Processes
  • Medical Device Classification Product Codes
  • The Pre-Submission Program and Meetings with FDA Staff
  • Mobile Medical Applications
  • eCopy
  • Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents

Draft Guidance Topics
  • Distinguishing and Reporting Medical Device Recalls from Product Enhancements
  • Types of Communication During the Review of Medical Device Submissions
  • FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations
  • eCopy
  • Appropriate Use of Voluntary Consensus Standards in Premarket Submissions

Device guidance documents that the Agency intends to publish, as the Agency’s guidance-development resources permit each in FY 2013 ("B-list")


Final Guidance Topics
  • Finalizing existing draft guidance documents.

Draft Guidance Topics
  • Benefit-Risk Determinations in Premarket Notifications (510(k)s)
  • Direct to Consumer (DTC) Genetic Testing: IVDs
  • Transfer of Ownership of a Premarket Notification (510(k)) - Questions and Answers
  • Custom Devices


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Thursday, November 29, 2012

GMP Training - It's Time To Start Planning

Updated December 6, 2025

GMP Training - cGMP Training - Plan your upcoming year!

It's time to start planning your upcoming new year QSR and cGMP training, and consider engaging SkillsPlus International Inc. as your external trainer.
  1. Tackle the new year now! Coordinating future training is involved, so get ahead of the new year before it arrives. Waiting to start planning conversations in the new year only perpetuates delays, and contributes to pushing off training to the last minute.  
  2. Send the right message!  By delaying early planning for next year's training, there's a risk of sending unintended and unspoken messages that training isn't very important.
  3. Deliver the best training!  Brainstorm your training needs with the leaders in GXP compliance training. Sometimes discussing things with, or bringing in external trainers can ratchet up the quality of training that students will experience. SkillsPlus International Inc. is a leader in compliance training, having trained thousands of students, over more than 30 years. Past students rave about the engagement and interactivity experienced in SkillsPlus courses.
Partner now with SkillsPlus International Inc. for your upcoming year's QSR & GMP training needs, to ensure that your Master Training Plan delivers timely quality training programs throughout the coming year. Simply visit our website to get started:

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