Appropriate as a GMP Microbiological Refresher
With the increasing number of Regulatory Actions throughout North America to include Form FDA 483s and Warning Letters for both Active Pharmaceutical Ingredients (APIs) and finished products, it has become increasingly important for companies and individuals manufacturing both non-sterile and sterile final products, to have a basic understanding of microbiology — regardless of the department in which they work.
Every individual within varying departments from Facilities to Manufacturing to Quality Control should understand the basics of microbiology and the issues that non-compliance can create. Recently, a large multi-national pharmaceutical company was cited for the second time by the FDA for not determining that mold was growing on the “clean side” of the HEPA filters in an ISO Class 5 environment after it had been identified by mechanics several years previously.
In addition, a Form FDA 483 (January 2011) which was subsequently followed by an extensive recall (January 2011), a seizure, and ultimately a Consent Decree for a manufacturer of non-sterile and sterile alcohol prep pads, swabs, and swab sticks, illustrate the importance of having knowledgeable personnel regarding microbiological procedures within your manufacturing and laboratories facilities. This facility received multiple observations for not providing its personnel with adequate microbiological training and ultimately closed.
The objective of this accredited course is to provide for the non-microbiologist an introduction and background to enable this individual to understand the basics of microbiology, as well as provide to the microbiologist (who may have moved on to other areas) a refresher course which addresses selected issues and answers facing those that may have microbiological concerns within their facilities. Plan to bring a cross-functional group of your personnel to attend this invaluable seminar.
Upon completion of this course, you will be able to:
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This course is intended for all scientists and technologists interested in developing a basic understanding or refresher of the basics of microbiology and the ramifications of non-compliance.
The material will be presented in such a way as to be of value to varying levels of expertise.
This course will especially benefit those in:
When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.Learn more
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