Microbial Contamination Investigations

מרצה: Mrs Ziva Abraham

תאריך: 22, 23 פברואר 2015
מיקום הקורס: כפר המכביה, רמת גן
מידע כללי
משך הפעילות: 2 ימי לימודים מלאים
שעות:  09:00-17:00
עלות: 4,300 ש"ח + מע"מ
נקודות זכות: 2
מק''ט: 15695
שפת הקורס: אנגלית
על הקורס

Microbial contaminations have many consequences. Inconclusive investigations and continuing contamination events are frequently associated with voluntary or involuntary plant shutdowns, product recalls, and warning letters.

קהל היעד

This course is valueable to personnel in:

  • Quality Assurance & Valiation
  • QC Microbiologists
  • Research and Development
  • Regulatory affairs
  • Manufacturing
  • Facilities
  • Engineering
  • Materials Management
  • From the following fields: Food, Biotech, Pharma, Cosmetics, Waste water, Biofuels
Microbial Contamination Investigations
התועלת שתופק

This comprehensive two day course on investigation of microbial contamination in cleanrooms, manufacturing processes, laboratory testing, and products will provide the practical tools needed for conducting in-depth investigations. Investigations are cost and labor intensive; detection of microbial contamination requires prompt attention and a good understanding of contaminants. Learn how to conduct and document meaningful investigations in order to prevent future contamination events, remediate current contamination issues and assess risk to product.

השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס

Day 1
Investigating Mold Contaminations
Mold contaminations are the least understood in the Pharmaceutical or Medical Device Industry. Many do not discover there is an existing mold issue until it has made its presence in the cleanroom in large quantities or has ended in the product circumventing antimicrobial efficacy. Mold unlike bacteria has various methods of propagation and in spore form can remain dormant till conditions are favorable. Understand how not to create favorable conditions for mold to grow.

This crash course in mold classification, methods of reproduction and their ability to withstand many disinfectants will help understand and prevent product contamination.

  • Understanding the three major groups of mold found in cleanrooms
  • Knowing how variants within each group differ in nature and structure
  • Simple keys to understand the different mold
  • Why fungal identification results could be misleading
  • Common contaminants in facilities that can proliferate
  • How different groups react to different disinfectants
  • What type of mold to consider when conducting disinfectant qualification
  • Points to consider when investigating mold contamination
  • Why excessive cleaning and disinfection is not the solution

After this training you will never put all mold contaminants in the same basket-you will want to know the real cause

Investigating Environmental Monitoring Excursions

The first step for investigating environmental monitoring excursions is to ensure that the excursion is not due to operator error. Often lot of energy is expended in investigating excursions that are not due to environment being out of control but due to analyst or laboratory errors.

Learn how to identify true and false excursions and proceed accordingly with the investigation.

  • Verify it is not an error
  • Validate the microbial identification
  • Separate Excursions from Out of specifications
  • Developing and action plan when an excursion occurs
    • Are the counts correct?
    • Is the ID correct?
    • Is it an objectionable?
  • Planning an investigation – information to be collected
  • How far back should you go or can you go for data review
  • Three step approach
    • Estimated cause(s)
    • Probable cause(s)
    • Root cause
  • What are corrective actions and how effective are they
  • When is it appropriate to use EM data as a product release criterion?

Day 2
Investigating Sterility Test and Media Fill Failures
This presentation will discuss the importance of Media Fills as the true parameter for assuring that a manufacturing process is capable of producing sterile pharmaceuticals using an aseptic process. Investigating sterility test and media failures have to be thorough for ensuring product quality and patient safety.

  • Discussion on Aseptic Media Fills and Sterility Testing
    • Similarities and differences between the two
  • Discussion on Validation of Aseptic Processing Guidance for Industry
  • Elements of Investigation for Failed Media Fill Runs
    • Facility
    • Equipment
    • Personnel
    • Training       
  • Addressing unusual events during media fills
  • Consequences of contamination during media fills

Investigation of Microbiological Out of Specification Results
Understanding the difference between an excursion and a true OOS is the first step. Many laboratory errors may contribute to OOS in Microbiology. A step by step evaluation of laboratory techniques and differentiating a lab error from a true representation of risk to product.

  • Investigating
    • Laboratory errors
    • Mistakes in making dilutions
    • Malfunctioning lab equipment
    • Mistakes in calculations
    • Mistakes in dispensing
    • Mistakes in transcribing numbers
    • Processing the wrong samples
    • Performing the wrong procedure
    • Inadequately trained personnel
    • Improperly prepared reagents
    • Changes in vendor reagents/materials
    • Expired reagents
    • Improperly maintained stock cultures
    • Aseptic techniques not followed
  • Retesting strategy
  • Resampling, when and how
  • Importance of documentation

Adequate Documentation of Microbial Investigations
Investigations reports need to be a thesis!

Writing lengthy investigation reports where the key elements such as   the event, presumptive causes of contamination, investigated causes and one or multiple root causes, remediation and corrective actions and the effectiveness of such actions are not clearly and chronologically documented may become onerous for the reviewer or regulator.

Learn how to document an investigation in a way that is conclusive and convincing.

  • What was the event
  • How long before it was discovered
  • Decide upfront if it is a risk for the product and to the patient
  • Do not mask the risks, it may lead to problems later
  • Assumed vs. investigated causes
  • Remedial vs. corrective actions
  • Measuring effectiveness
  • Change controls
  • Measure confidence
  • Everything relates to product and patient
אודות המרצה

Mrs Ziva Abraham

Ziva Abraham a known microbial contamination control expert and a seasoned mycologist has educated industry on fungal identification and investigating mold contaminations for over two decades. Her understanding of the origin and behavior of mold makes her a well respected investigator for mold contaminations. She has over 25 years of academic, research, clinical and industrial experience in Microbiology, and Quality Assurance.
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