Wednesday, May 29, 2013

FDA : Draft Guidance - Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability

Comments are due to FDA by July 29, 2013.

Federal Register | Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability:

"This guidance describes our current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy."

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Thursday, May 2, 2013

Food or Dietary Supplement - Therapeutic Claims = Drugs

FDA Law Blog: Using Scientific Literature in Food or Dietary Supplement Marketing? Proceed with Caution:

"Recent actions by FDA and the FTC serve as reminders that both agencies will consider the use of scientific literature in determining whether marketing for a food or dietary supplement conveys disease treatment or prevention.

FDA recently issued a warning letter to a company that sells eye health dietary supplements. FDA alleged that the company’s website included “therapeutic claims” that established that its products were unapproved new drugs."

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Wednesday, May 1, 2013

Choose Live On-Site Instructor-Led GMP Training - - Benefits

On-site training, taught live by an instructor, is the perfect choice for companies that need to train groups of employees.

The Benefits of Live On-Site Instructor-Led cGMP Training:

You'll . . .
  1. Get a maximum number of employees trained in new skills in a minimal amount of time on the date, and location of your choice. 
  2. Be able to deliver the same customized message & course content at the same time, ensuring everybody gets on the same page. 
  3. Ensure knowledge & skills transfer from classroom to workplace.
  4. Get an expert trainer's insights and hear real-world examples.
  5. Experience face-to-face interaction with real-time feedback.
  6. Get a more comfortable training environment that supports the learning of complex material.
Taking advantage of onsite instructor-led training classes gives you the optimal balance of facilitation, group exercises, case studies, and practical application exercises. Call our master trainer, Allan Dewes, to arrange your next client site class, (954) 873-7422.

Explore the full line of SkillsPlus Intl Inc. live on-site courses:
On-Site cGMP, QSR, and Other Compliance Training Courses by SkillsPlus International Inc.

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