Thursday, November 29, 2012

2013 GMP Training - It's Time To Start Planning

It's time to start planning your 2013 QSR and cGMP training, and consider engaging SkillsPlus International Inc. as your external trainer.
  1. Tackle 2013 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 2013 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 20 years. Past students rave about the engagement and interactivity experienced in SkillsPlus courses.
Partner now with SkillsPlus International Inc. for your 2013 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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GHTF Archives Can Be Found On The IMDRF Website

SkillsPlus International Inc.: Overview | LinkedIn:

"The Global Harmonization Task Force (GHTF), the global medical device harmonization body no longer exists. The GHTF has been permanently replaced by the IMDRF (International Medical Device Regulators Forum), a successor organization comprised of officials from regulatory agencies around the world. The GHTF website no longer exists. Fortunately, the GHTF Archives are now housed on the IMDRF website. These archives (follow the hyperlink below) should be considered historic information, no longer current, and therefore, should not be acted upon.

http://www.imdrf.org/ghtf/ghtf-archives.asp "

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Thursday, November 22, 2012

FDA Adopts ICH Q11 (Development & Manufacture of Drug Substances)

The Food and Drug Administration (FDA) posted a guidance entitled “Q11 Development and Manufacture of Drug Substances.” The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes approaches to developing and understanding the manufacturing process of a drug substance and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities). The discussion of principles in the guidance is intended to apply only to the manufacture of drug substance, not the manufacture of finished drug products.

Related Links:
FDA Guidance for Industry - Q11 Development and Manufacture of Drug Substances (PDF)
ICH Q11 - Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological Biological Entities)  (this links navigates to a page containing Q11-related documents)

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Tuesday, November 13, 2012

Why GMP Training Does Seem To Work

Why GMP Training Does Seem To Work
Free Training Tips from SkillsPlus International Inc. - by Allan Dewes

GMP training doesn’t always seem to make a difference. We send our employees to class, yet they never change their compliance practices. Perhaps our employees are doing what we unintentionally encourage them to do – even though it’s not what we really want. There can be several reasons for this:
  1. poorly designed or delivered training, 
  2. a disconnect between what is taught in class and what is professed on the line and in meetings, and 
  3. a lack of an organizational infrastructure to support and encourage GMP compliance 

Poorly Designed or Delivered Training 
A good design doesn’t have to look good, but it helps. A good design follows a logical flow and links concepts together in a logical flow that leads to a logical conclusion of what is the appropriate behavior. Employees need to know what the gaps are between what is currently practiced, and what is expected. However, even the best design in the world may be totally ineffective if the class is asleep. For instance, employees that have been working for eight hours before a class, are often made to sit in a dimly lit conference room, listening to the instructor drone on for the 93rd time about using black ink in documentation. GMP training delivery must be alive – kick it up! Remember, as trainers we are competing with the jazz of Nintendo, Wii, iPad, smartphones, and the Internet. Activities that reinforce learning objectives are a great way to jazz up training for even the most reserved trainers.

Disconnect Between Preaching & Practice 
A telltale sign of a disconnect between what is preached in the organization and what is practiced can be quickly assessed in the plant floor rumblings. Have you ever heard someone say, "I know what ‘they’ told me in class, but my supervisor wants me to get the product out the door." Perhaps you recently heard, "Those trainers don’t know how the job is really done around here." Or maybe you heard, "Tell management about these rules, they need to hear it." These comments are usually countered with, "Where did they ever get those ideas from? Of course I want GMP compliance!" However, somewhere in the employee’s work life they heard a message different than the one you intended. For example, the speed limit on many highways is stated as 65 mph (your area may be different). The message appears to be clear, but many drivers exceed the speed limit. So, what is the message many drivers hear – it’s okay to drive 70 mph. Is that second message intentional or not? Is it spoken or unspoken? Do we send the right messages about our compliance intentions?

Lack of Organizational GMP Compliance Support and Encouragement 
If behavior doesn’t change, so say behaviorists, then the environment hasn’t encouraged or supported the desired change. Let’s continue the analogy of the driver speeding on the highway. There are obviously little or no consequences for exceeding the speed limit by perhaps 5-7 mph. (Please note: I’m not giving drivers permission to exceed the speed limit, nor am I liable for those who do get tickets, I’m merely reporting an observation.) What would happen if we were all (100% of us) given speeding tickets for even 1 mph over the limit? Behavior would change, or some of us would go broke. So how are we doing in the area of GMP compliance in our plants? I see many QA auditors correcting batch records with little or no feedback to the person who made the mistake for the 93rd time. I see people responsible for SOP updates that can’t get comments back because, "We were too busy." I see trainers with empty classes because we had product to get out the door.

The Recipe For A Successful GMP Compliance Initiative Includes: 
  1. Strong training program design 
  2. Delivery with the energy and jazz of current entertainment media 
  3. Rich and accurate content 
  4. Consistent messages with the practices demonstrated by our behavior and decisions 
  5. Organizational systems that encourage and support GMP compliance! 
  6. Have SkillsPlus Intl Inc. deliver your next training. Call:  (415) 487-3500 or (954) 873-5422 

About the Author 
Allan Dewes is the President and Founder of SkillsPlus International Inc. Allan is a master trainer, possessing over 25 years experience in identifying training needs and designing QSR & cGMP training programs. He is known for designing user friendly courses and conducting highly interactive classes that teach concepts easily and playfully.

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Monday, November 12, 2012

Regulators, Industry Discuss Potential Impact of IMDRF

The International Medical Device Regulators Forum (IMDRF) may be the newest global harmonization body.

Regulators, Industry Discuss Potential Impact of IMDRF > RAPS > News - Article View:

"Unlike GHTF, which was a blend of agency regulators and industry representatives, IMDRF relegates industry to a consultation role while keeping regulators in the drivers' seat. "After 20 years, time for a change," said Minor

This desire for accelerated change is written into the agency's mission, observed Trautman, speaking to the session by video link after an East Coast hurricane prevented her from attending in person. "The mission of the IMDRF is to strategically accelerate international medical device regulatory convergence to promote an efficient and effective regulatory model for medical devices that is responsive to emerging challenges in the sector while protecting and maximizing public health and safety," she relayed, quoting its mission statement."

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You might also be interested in:
Essentials for Medical Device Manufacturers - A Training Course - Teaches the FDA QSR Regulations

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Sunday, November 11, 2012

Consider On-Site Training - Popular GMP Classes and QSR Courses

Comprehensive master training plans often take advantage of a 'blended' training approach . That is, a mixture of multiple training modalities, including online training and live instructor-led classes.

As 2013 approaches, you might want to consider and/or justify bringing in SkillsPlus Intl Inc. to deliver your on-site in-person training classes.


Consider these features and benefits of live, on-site, in-person training.

Convenient, Flexible, & Interactive 
  • You get to pick the date, time, & location – adjust for shifts, or number of days that works best for your employees; select your facility, plant, training center, or other desired location 
  • In-person training engages students – with the right instructor on-site training encourages interaction according to class size and level of training, ensures consistent messages, and fosters team building 
Content That Fits Your Needs 
  • Your training needs are addressed - training content & activities are adjusted, based on students’ prerequisite & current skill levels, and the organization’s specific needs, objectives, issues, and challenges. Tailoring the content ensures that training is unique & relevant. 
  • Confidential issues can be covered - Training on-site means you can candidly discuss your organization's unique challenges and opportunities. Sensitive company information can be shared by participants and used as concrete examples during interactive and workshop sessions in complete confidence. 
Great Value 
  • Avoid having to leave the building - Without ever leaving the building, staff can gain new skills, boost their confidence, and improve their productivity. Since on-site training takes place at client’s premises, there is no travel, no time away from the plant, and no unrelated expenses that are often associated with public courses (e.g. travel, hotel, subsistence, etc.). 
  • You get live in-person expert instruction! The best on-site teachers are skilled facilitators and/or consultants. With the right instructor, you get the added advantage of getting expert advice alongside the training.
You won't be disappointed by selecting SkillsPlus Intl Inc. to deliver your on-site training. Our past students say that they love our interactive style, learn a lot that they can put into immediate use, and recommend us to their industry friends.


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Saturday, November 10, 2012

November is Natl Home Care and Hospice Month

California Association for Health Services at Home:

"November is National Home Care & Hospice Month

Celebrate the Heroes of Home Care
Each November, the California Association for Health Services at Home (CAHSAH) along with the entire home care industry throughout the country celebrates National Home Care and Hospice Month to honor care giving heroes who make a remarkable difference in the lives of patients and the families they serve. It is an important opportunity to recognize the health care administrators, nurses, clinicians, therapists, aides, homemakers, chore workers, companions and other home care professionals who assist some of our most frail citizens and help them to remain at home and in the community.
“During National Home Care and Hospice month, we take time to honor the thousands of individuals in home care and hospice who, on a daily basis, provide remarkable care in people’s homes. Thank you for all that you do.” - - - CAHSAH President Joe Hafkenschiel"
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You might also be interested in:
CA HMDR Exemptee online training certification - for HME DME retailers wholesalers
The Designated Representative and Exemptee Blog

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CA Designated Representative internet-based training certification by SkillsPlus Intl Inc.
FL Designated Representative web-based exam preparation by SkillsPlus Intl Inc.

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