Monday, June 29, 2015

Who Offers GMP Training?

Updated March 10, 2021

Given the COVID-19 pandemic, people also search for:

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Who Offers GMP Training?

SkillsPlus International Inc. offers highly respected cGMP training. Here's why you need to choose SkillsPlus Intl Inc.:

SkillsPlus Intl Inc. can be your one-stop shop that: meets your needs, wows students, and makes your training delivery easier!

Visit SkillsPlus Intl Inc. training products & services, or call (415) 948-5220.

#FDA #GMP #training #cGMP #courses #classes

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Thursday, June 25, 2015

FDA slaps U.S. drugmaker over drug testing issues - FiercePharma Manufacturing

Read the full article: FDA slaps U.S. drugmaker over drug testing issues - FiercePharma Manufacturing:

"Inspectors were particularly troubled with batch testing after inspectors found "multiple incidents of inaccurate batch production records containing erroneous statements, including results that were not derived from analytical testing" or from certificates of analysis (CoAs) of its suppliers."

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You might also be interested in the following GMP training course:

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SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Wednesday, June 24, 2015

New FDA Guidance to Avoid Overfill of Vials - ECA GMP News

Updated February 1, 2021

People are also asking about:

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Read the full article: GMP News: New FDA Guidance to Avoid Overfill of Vials - ECA:

"If a liquid is withdrawn from a vial by means of a syringe, remains of the liquid stay in the vial or on its walls. Since it is nearly impossible to extract 100 % of the liquid but the dosage has to be correct, nevertheless, vials usually are slightly overfilled. A vial with a dosage of 1 ml might for example contain 1.1 ml. The FDA has two points of concern: on the one hand some manufacturers fill up to much or not enough drug products without sufficiently justifying this which may result in medication errors. On the other hand the leftover of several vials with excess volume could be pooled to obtain a further dose which could lead to microbial problems."

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View the guidance:
Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products - FDA Guidance for Industry (PDF)

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
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Root Cause Analysis - GMP Training
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Wednesday, June 17, 2015

Ex-Homeland Security cyber chief warns of threats to outsourcing firms - Outsourcing Pharma


Read the full article: Ex-Homeland Security cyber chief warns of threats to outsourcing firms - Outsourcing Pharma:

. . . "drug companies should consider the weaknesses in all their relationships, from research contracts to materials supply, big data, logistics, cloud solutions such as SalesForce used by sales and marketing companies, and file-sharing services."

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SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around