Key Microbiology Audits

מרצה: Mrs Ziva Abraham

תאריך: 25, 26 פברואר 2015
מיקום הקורס: משרדי ביופורום, גולדה מאיר 3, נס ציונה. קומה 4
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: 15697
שפת הקורס: אנגלית
על הקורס

The risk of non-compliance related to microbiological causes is too great in terms of FDA observations, warning letters, patient safety and loss of consumer confidence. Beyond auditing microbiological aspects of manufacturing in-house, key vendor audits that can have an impact on the microbiological quality of product are crucial. Moreover, personnel performing audits where microbiological quality is critical may not have the expertise to do so.

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

Key Microbiology Audits
התועלת שתופק

This intensive two day course will emphasize the importance of performing microbiological quality audits of manufacturing, microbiology laboratories, product contact compressed air or gas suppliers, gown suppliers and media suppliers. An in-depth audit of these systems provides confidence in product quality and microbiological test integrity.

Additionally, for non-sterile products, the manufacturer is required to define microorganisms that will be objectionable via the mode of administration. To understand objectionable microorganisms, clinical microbiology expertise is required. Most QC laboratories lack this expertise, and may not know where to find this information, how to test for these unique organisms and identify real risk.

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

Day 1
Auditing Microbiological Aspects of Aseptic and Non-Aseptic Manufacturing
This presentation will outline the microbiological aspects of the Quality Systems; learn the systems based approach while auditing microbiological aspects of pharmaceutical, medical device and biopharmaceutical manufacturing. Using a Quality Systems inspection (QSIT) approach, the presenter will teach how to look for microbial contamination risks in both aseptic and non-aseptic manufacturing environments.

  • Audit team for microbiology related audits
  • 21 CFR 211 and 21 CFR 820 step by step interpretation of the subparts with a focus on microbiology and contamination control
  • QSIT Approach for audit - Drugs and Devices
  • Microbiological Validation Master Plan – A roadmap to microbiology systems
  • Auditing microbiological data and their traceability for lot release and product reviews
  • Trends related to microbiological data deviations
  • Microbiology laboratory
  • Microbiological validation and qualification protocols and reports
  • Microbiology Audit Reports- special considerations

Auditing Contract Microbiology Laboratories

Quality personnel assigned the task of auditing contract microbiology laboratories may not have the expertise to provide a perspective on this task.  Beyond quality systems there are other aspects of microbiology laboratories that require a closer look through a well trained eye. Though this webinar will not make untrained microbiologists experts in the field it will provide relevant guidance and training to evaluate contract microbiology laboratories from a risk based perspective.

  • Importance of establishing an internal or external audit program for QC microbiology laboratories.
  • Discussion on the regulatory requirements and industry guidelines
  • Discussion on FDA’s Guidance on auditing the microbiology laboratory
  • Laboratory facility design and segregation of laboratory operations
  • Sample handling, storage and tracking
  • Media preparation and media handling
  • Microbiological test methods
  • Validation of test procedures  
  • Quality Systems
    • Quality systems procedures
    • Сontamination control strategies
  • Documentation and Data Storage
  • OOS and Corrective Actions
  • Management of complaints
  • Level of expertise and training of analysts

Auditing Microbiology Media Suppliers

More often than one would presume, growth on microbiology  media  may not be representative of product quality or environment. Dehydrated media is made by media companies and are considered in vitro diagnostics. Media suppliers prepare liquid and solid media from purchased dehydrated powder media. Dehydrated media is not necessarily sterile, it the processes that it goes through at the media manufacturer that makes it sterile and conducive to use for the microbiology laboratory. There are many steps and precautions that need to be taken by the ready to use, microbiological media supplier that will dictate the success of microbiological testing

  • Receiving dehydrated media an storage conditions
  • Quality control procedures for accepting dehydrated media
  • Does the powder media have to be used ill it expires- disposal methods and documentation
  • Agar media-preparation methods
    • Precautions
    • Dispensing errors
    • Storage conditions
  • Packaging
  • Irradiation
  • Quality control before shipping
  • Inspection and rejection
  • Shipping conditions
  • Accompanying certificates
  • Handling complaints
  • Quality Systems

Day 2

Auditing Cleanroom Gown Suppliers
Understanding product requirements for cleanroom apparel in sterile and non sterile products is crucial to effectively audit gown suppliers. Suppliers of disposable and laundered gowns have requirements and testing that must be met in order to be considered for use in cleanrooms. Learn about the standards, test methods and operational strategies that can be used as audit tools.

  • Brief overview of reasons behind gowning
  • Common gowning errors
  • IEST-RP-CC003 recommendations
  • Other standards followed by  suppliers
  • Sterility assurance for laundered gowns-11137-1
  • What to look for during the audit
  • Discussion on gowning related FDA 483 observations

Understanding Compressed Gases for a Meaningful Audit
Compressed gases are important components of manufacturing and R&D in the Pharmaceutical, Biotech, and Medical Device Industries and deserve a careful attention.  

  • Discussion of various types of compressed gases and related applicable testing
    • o    Outline and discussion of regulatory bodies:
      • International Organization for Standardization
      • European Union Annex
      • U.S. Food and Drug Administration
      • National Fire Protection Association
  • Guidance on types of testing required by each regulatory body
    • Outline of priority tests to satisfy regulatory bodies

Objectionable Organisms- Audit your microbiology data

FDA expects manufacturers of non-sterile products to identify and prevent microorganisms that are objectionable. This responsibility lies with the manufacturer of the product. Passing the sterility test for a sterile product made by aseptic processing does not guarantee that the entire batch is free of objectionable microorganisms.

There is very little understanding in the industry on what organisms should be considered objectionable. At times the specified organisms outlined in USP<1111> are the only ones considered objectionable leading to release or product with microorganisms that may harm the patient.

  • FDA’s expectations regarding objectionable microorganisms
  • Understanding USP <1111> and other guidelines related to objectionable microorganisms
  • Bacteria and Fungi that cause oral diseases and can be objectionable in oral and gingival products
  • Bacteria and Fungi that cause naso-pharyngeal or lung infections and can be objectionable in nasal or inhalation products
  • Bacteria and Fungi that can be objectionable in aqueous and non aqueous oral products
  • Bacteria and Fungi can be objectionable in ointments and patches causing Cutaneous and Sub-cutaneous infections
  • Bacteria and Fungi that can cause ear and eye infections
  • Microorganisms that can be objectionable in rectal and vaginal products
  • Microorganisms that cause systemic infections
  • How to perform research on whether the microorganisms found in your product have a chance of causing harm to the 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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