6 Best Training Courses on Cleanrooms: How to Maintain and Control Contamination/Disinfection

This webinar will provide valuable guidance on how to maintain cleanrooms and all the related regulations, techniques and operations related to it. And also will guide you about various strategies to avoid risks and implication for cleanrooms.
Instructor: Tim Sandle, Kierstan Andrascik, Joy McElroy
Product ID: PACK70069

CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations
  • Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants
  • Get unlimited access for Recorded links
  • Free shipment of CDs within 72 hours from the date of purchase
  • Reference materials for Webinar Recording Link/CDs will be mailed to your registered e-mail id

Webinar Topics:

Who will benefit?

  • Production and manufacturing
  • Engineering
  • Regulatory personnel
  • Microbiologists
  • Regularity
  • Procurement
  • Students
  • Healthcare professionals
  • Facilities management
  • Infection control personnel
  • Cleanroom operators
  • Pharmaceuticals
  • Healthcare
  • Medical devices
  • Biotechnology
  • Academia
  • Disinfectant validation managers
  • Operations managers
  • Cleanroom managers
  • Personnel and contractors that clean and disinfect cleanrooms
  • EH&S managers
  • Regulatory compliance managers and environmental monitoring managers
  • QA/QC managers and personnel
  • Validation managers and personnel
  • Manufacturers of implantable medical devices
  • Manufacturers of single-use medical devices
  • VP, Directors and Managers of medical device design functions
  • Manufacturers of reprocessed/reusable medical devices
  • Risk Managers

Webinars included in the Package:

ISO 14644 - The Revised Standard and Implications for Cleanrooms (Duration: 60 Minutes)

The international standard for cleanrooms has undergone a major revision. This webinar discusses the revisions in the context of global GMPs and the overall contamination control strategy. The webinar discusses testing approaches and the assessment of test data. The learning point is with keeping cleanrooms compliant.

Objectives of the Presentation:

  • How to assess a cleanroom as built, at rest and in operation
  • How cleanroom standards inter-link to global GMPs
  • How to evaluate cleanroom data
  • How to assess cleanroom contractors
  • The importance of a risk based approach
  • Assessing microbial and particulate risks

Instructor Profile:

Tim Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing.

Global Best Practices for Cleaning and Disinfection of Cleanrooms and Disinfection Validation(Duration: 60 Minutes)

Cleaning and disinfection of cleanrooms is of great importance as part of a contamination control strategy. For this to be effective, correct disinfectants need to be selected, rotation between biocides must in place, a Sporicidal agent needs to be selected, disinfectants need to be qualified cleaning frequencies need to be established, and appropriate training given. This is hampered by the lack of a global approach to satisfy regulatory agencies. This webinar provides an overview of the focal points required to achieve a global approach for cleanroom disinfection.

Objectives of the Presentation:

  • What is cleaning and disinfection?
  • How to select disinfectants?
  • Global guidelines for disinfection in cleanrooms
  • EU GMP (& draft Annex 1), USP <1072>, FDA aseptic processing guidance, PIC/S
  • How to use disinfectants effectively
  • Points for success
  • Approaching disinfectant validation: Differences between European and U.S. standards
  • Practical approach to disinfectant validation: what is best for pharma?
  • Legal requirements for disinfectants: Europe and U.S.

Instructor Profile:

Tim Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing.

Control of Cleanroom Garments and Supplies: Contamination Control(Duration: 60 Minutes)

This webinar considers the important considerations for the control of operators in cleanrooms so that microbial and particulate contamination can be reduced. The focus is with people being the main contamination source within cleanrooms. Considered in the webinar are: Selection of gowns, gowning requirements, gowning tests, environmental monitoring associated with people, selection of gloves and facemasks. Other topics considered include the differences between disposable gown and re-laundered gowns, gown repair policy, and sterilization of gowns.

Objectives of the Presentation:

  • Major contamination sources within cleanrooms
  • Trends in operator derived contamination
  • Cleanroom design and operation
  • Variances with particle generation
  • How to select gowns, gloves and face masks
  • How operators should be trained
  • How to target microbiological environmental monitoring
  • Investigating out of limits events
  • Data review

Instructor Profile:

Tim Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing.

What to identify? Why Screening Cleanroom Microbes Matters(Duration: 60 Minutes)

This webinar will look at microbial identification for pharmaceutical and healthcare facilities, examining the common types of organisms isolated from pharmaceutical cleanrooms; the methods of identification; and the inferences that can be drawn from identification patterns; how often to identify and when to identify; ways to trend cleanroom microorganisms; the level of detail that can be assessed from genotypic and phenotypic identification; and the uses of isolates in terms of the testing of culture media, use in microbial validation; and for disinfectant efficacy testing.

Objectives of the Presentation:

  • Common types of microorganisms from pharmaceutical and healthcare cleanrooms
  • Identification strategy
  • What variances in trend signify, e.g. a shift in spore-forming organisms
  • Actions to take for out-of-trend situations
  • Methods for trending
  • Differences between identification technologies
  • Different types of culture media

Instructor Profile:

Tim Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing.

Understanding and Preventing Cleanroom Contamination: Gaining and Re- establishing Control of your Cleanroom(Duration: 90 Minutes)

This webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case even

Objectives of the Presentation:

  • The critical steps needed to release the room for manufacturing will be discussed
  • Routine cleaning and disinfection strategies will be covered as well as the latest in equipment and application
  • Establishing control of the cleanroom after a worst case event
  • Excursion events will be discussed and case studies will be covered regarding excursion events

Instructor Profile:

Joy McElroy With over 20 years of total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing.

Cleaning Validations Using Extraction Techniques (Duration: 60 minutes)

Cleaning validations are an essential step in the medical device development process. One of the most common methods is using extraction techniques to validate the cleanliness of a device. This webinar will provide valuable guidance on how to achieve a thorough validation of a cleaning process. These cleaning processes may include initial cleaning validations, in process cleaning validations, or reprocess cleaning validations.

Objectives of the Presentation:

  • Importance of device cleanliness and cleanability
  • Basics of validating a cleaning process
  • Choosing test soils based on target contaminants
  • Available test methods for cleaning validations
  • Validation of the extraction method
  • Establishing and justifying residue limits

Instructor Profile:

Kierstan Andrascik founder of QVET Consulting, with her years of experience in the medical device industry assists manufacturers with their validation needs. She specializes in cleaning validations for both new and reprocessed medical devices and has established herself as one of the foremost experts in medical device cleanliness.

Price:$700.00
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