Wednesday, January 23, 2013

Things To Do in FL - When here for our GMP Trainer Certification Course May 6-10, 2013

English: This image was taken from the 17th St...
Things to do while you're here in the Fort Lauderdale & Miami area for our public seminar:
Sign-up soon to get the early registration discount for our upcoming May 6-10, 2013 Public Seminar in Fort Lauderdale, FL.
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

Learn more about SkillsPlus Intl Inc. products & services:  http://www.skillsplusinc.com/

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Tuesday, January 22, 2013

FDA Final Rule on Combo Product CGMPs - New!

Fda
Fda (Photo credit: Wikipedia)
Hot off the press!

This final rule clarifies which CGMP requirements apply when drugs, devices, & biological products are combined to create combination products:

Current Good Manufacturing Practice Requirements for Combination Products - A Rule by the Food and Drug Administration on 01/22/2013

In a nutshell:

The FDA is issuing this regulation on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for "single-entity" and "co-packaged" combination products.

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Tuesday, January 15, 2013

QSR GMP Trainer Certification in FL - May 6-10, 2013

Updated May 6, 2014:


Did you miss our public seminar? We also offer this program as an on-site course conducted at your location. Give us a call: (415) 487-3500, or learn more:  http://www.skillsplusinc.com/Pub_Sem.htm

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You've been clamoring for our public seminar at an East Coast location, so here we are!
Visit warm and sunny Fort Lauderdale, FL in May, for this highly recommended public seminar course.


Register soon to qualify for an early registration discount.

This is the most popular trainer certification course on the market!
  • Learn how to train CGMPs and QSR courses from successful compliance professionals
  • Experience, practice, and master the skills to make compliance training fun, informative, and exciting
Graduates of this course say that attending this public seminar is a life-changing event!

Overview:
This is a five-day public seminar that leads participants through many different ways to teach CGMPs and QSRs. Learn what your instructor is thinking about during sessions, so that you can repeat that training approach in your organization. Students make two presentations demonstrating their skills during the class. This class is also suitable for food and dietary supplement manufacturers.

Course Details:

Participants will learn how to:
  • Explain the essentials of the CGMP/QSR regulations.
  • Use the philosophical basis for the rules and interpretation to respond to CGMP/QSR related questions.
  • Demonstrate techniques to present CGMP/QSR content in memorable ways.
  • Design and conduct activities that reinforce learning.
  • Facilitate discussions and questions like a pro.
  • Respond to difficult questions.
  • Deal successfully with difficult students.
  • Manage classroom media
Event Details:
Date: May 6-10, 2013
Location:  Fort Lauderdale, FL
Seminar & Lodging Location:  Pelican Grand Beach Resort in Fort Lauderdale

Additional Information:

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Monday, January 7, 2013

FDA - Proposed Rules To Implement FSMA

Food and Drug Administration logo
Food and Drug Administration logo (Photo credit: Wikipedia)
The FDA has released for public comment a proposed rule on Preventive Controls for Human Food and a proposed rule on Standards for Produce Safety. These rules are two of the proposed rules that are key to the preventive food safety approach established by the 2011 FDA Food Safety Modernization Act (FSMA). The proposed rules build on existing voluntary industry guidelines for food safety, which many producers, growers and others currently follow. FDA expects to soon issue its proposed rule on importer foreign supplier verification; future proposed rules will address preventive controls for animal food, and accreditation of third-party auditors.:
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