Microbiological Quality Considerations

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Microbiological Quality Considerationsin Non-Sterile Dosage Forms Manufacture

Expert Lecturer: Mrs. Karen Taylor (Ginsbury)

Categories: Manufacturing, Pharmaceutical/Biologics, Quality

SKU: 241119

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The objective of this course is to understand microbiological concerns from a process, product, patient and regulatory perspective:

To be able to review processes
To identify microbial hazards
To put in place appropriate controls
- Microbial Control Strategy
- FDA Draft Guidance on Microbiology for Non-Sterile Drugs
- USP / Ph Eur General Microbiology...Continue reading

The objective of this course is to understand microbiological concerns from a process, product, patient and regulatory perspective:

To be able to review processes
To identify microbial hazards
To put in place appropriate controls
- Microbial Control Strategy
- FDA Draft Guidance on Microbiology for Non-Sterile Drugs
- USP / Ph Eur General Microbiology Chapters:
  - <1111> Microbiological Examination of Non-Sterile Products
  - <1112> Application of Water Activity in Determination of Non-Sterile Pharmaceutical Products
  - <1231> Water for Pharmaceutical Purposes
- USP/Ph Eur Monographs:
  - <60> <61> <62> Microbiological Tests for Non-Sterile Products
  - Environmental Monitoring vs. Microbial Limit Test (vs. Bioburden)
Objectionable organisms / High plate counts for Microbial Limit Test
Use of preservatives to reduce the high microbial count
High counts in the Purified Water System and no testing for objectionable organisms
Ineffective quality management system

Dates: יפורסם בקרוב.
הקורס יפתח על פי רמת ההתעניינות בנושא.

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Course location: Virtual Course

Duration: 2 Day Course

Hours: 09:00 - 17:00

Credits: 2

Course Language: עברית

Course price: 4,600 NIS + VAT

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Issues to be covered

What is a control strategy for microbial risks
Contamination prevention vs. mopping up the mess
FDA’s draft Guidance on Microbiology for Non-Sterile Drugs
EU Annex 1 for Sterile Products – applicable or not?
WHO Guides? (HVAC for non-sterile manufacturing, other?)
The pharmacopoeias: general chapters – process vs. product monographs
The role of Environmental Monitoring
Cleaning and Disinfection
Recent inspection findings PIC/s Concept Paper on revision of Annex 11
What awaits industry in future inspections?
Quality Unit role vs. rest of management
Interactive Group Activity:
Develop a framework for a microbial control strategy in small groups for different types of non-sterile dosage forms

Who should attend

API / Drug Substance and non-sterile Finished / Drug Product manufacturers
R&D, Technology Transfer, QC / Microbiology laboratory personnel
Those involved in clinical trials, regulatory affairs, and manufacture, testing and oversight of microbial aspects of Investigational Medicinal Products will also find the course very useful
The course will be of particular value to small “virtual” start-up companies manufacturing and testing their product at CDMOs – contract manufacture and / or contract microbiology testing. In the absence of a microbiologist in the company, the course will allow understanding of the risks which need to be managed

Benefits to the Participants

Participants will come away able to develop a systematic microbial control strategy tailored to their process.

The strategy

Is tied in to and an extension of risk assessment/ control / management
Considers the process(es) and product(s)

About The Lecturer

Karen Taylor (Ginsbury)

Karen Ginsbury, CEO of PCI Pharmaceutical Consulting Israel Ltd. Karen