This webinar on Objectionable Micro-organisms will provide examples of objectionable microorganisms and will review specific actions to take when one is found. It will also review how to conduct an effective risk analysis to mitigate the risk they present.
Areas Covered in the seminar:
This course will focus on conducting the risk assessment and will include the following topics:
* Definition of an objectionable microorganism.
* The difference between pathogenic and objectionable microorganisms.
* The risk if an organism is found in a raw material.
* The risk if an organism is found in the environment.
* The risk if an organism is found in a sterile environment.
* The risk if an organism is found in a product.
* Factors to consider when conducting a risk assessment
o Potential risk from the organism, risk to the product, from the manufacturing process.
o Potential risk from the route of administration, from the patient population, from biofilm.
o Potential risk to products on the market, risk from customer complaints, risk from adverse events.
o Propagation study
* Examples will be given on
o Oral dosage facility
o Aseptic processing facility
* Product Safety and Quality
Please contact Customer Care to avail 15% Christmas Offer on Regular Pricing (650-620-3937)
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