Purchase on-demand webinar recordings

IEST webinar's are now available on-demand to purchase!* View the courses below that are currently available. More content coming soon.

Frequently Asked Questions

Q: How will I access the recording?

A: You will receive an email after your purchase with a link to the recording. You will be returned to type in your name and email before the recording is played. You will have access to view the recording for 30 days.

Q: Can the recording be view more than once?

A: Yes, you can view the recording more than once. Just use the same link that was emailed to you.

Q: Can multiple people view the recording?

A: No, the recording purchases are for one individual and you will be required to type in your name and email before the recording is played. If more than one individual would like to listen to the training, you will need to purchase the recording individually for them.

Q: Are CEUs issued for these classes?

A: Yes, CEUs are issued for these classes. These units will be applyed to your transcript on your IEST account. You can access this by clicking here.  You must login to your IEST account. This information is periodically updated and not updated in real time. If you need a certificate of completion emailed to you, please send your request to sstamatkin@iest.org.

Q: Do we receive a copy of the print presentation?

A: If you would like to receive a PDF copy of the presentations, please send an email to hwooden@iest.org. These are not automatically sent.



Selecting the Right Accelerometer

The course will focus on providing guidelines for the selection and application of accelerometers that are used in the measurement of shock and vibration. The course is based upon the IEST Recommend Practice (RP) document IEST-RP-DTE011: Mechanical Shock and Vibration Accelerometer Selection. The focus will be on the practical use of the devices and will act as an introductory course on accelerometers.

Pricing

Member: $225
Non-member: $285
CEUS: .3

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Airflow Visualizsation (AKA Smoke Studies) Techniques and Technology

Understanding airflow patterns in cleanrooms and controlled environments is an important aspect in contamination control.  Personnel, equipment, and material flow can influence airflow and affect contamination levels in even the most well-designed cleanrooms.

Air Flow Visualization (AFV) studies, sometimes referred to as “Smoke Studies” are useful in providing a visual representation of air flow in cleanrooms.  These studies (or series of tests) can also be useful in troubleshooting cleanroom contamination issues resulting from undetected air patterns that limit a cleanrooms ability to provide adequate contamination control.Though considered an optional test as listed in the international cleanroom standard, “ISO 14644-3:2019, Airflow Visualization is an expected test by pharmaceutical inspection authorities and mentioned in FDA, PIC/S and USP guidance documents. This 3-hour training will go into detail the techniques and technology behind smoke studies.

Pricing

Member: $225
Non-member: $285
CEUS: .3

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​Practical Considerations for Implementing a GMP Annex 1 CCS - Scope and Principle

A significant change in requirements, recommendations and detailed specifications are included in the GMP Annex 1 drafts. While the intent of Annex 1 is to provide guidance for the manufactures of sterile products; some of the principles and guidance such as a Contamination Control Strategy (CCS), facility design, cleanroom classification, qualification, monitoring, and personnel gowning may be used to support other medical product manufacturing.

This session will include:

  • Brief history of the document and the reasons behind the updates.
  • Discussion regarding the scope and its extension into non-sterile manufacturing.
  • Introduction to the various sections of the CCS

Pricing

Member: $98
No-member: $150
CEUs: .1

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Practical Considerations for Implementing a GMP Annex 1 CCS - Premises and Equipment

Cleanrooms are high technology environments designed to control and limit airborne particles and other types of contamination. The International Organization for Standardization (ISO) has a series of standards for cleanrooms and contamination control.  These standards are a baseline that is applicable for all industries. Cleanrooms used for medical products such as pharmaceuticals have additional requirements (beyond cleanrooms used in other industries) and regulations that apply to the design, construction, qualification, and operation. GMP Annex 1 introduces a grade system related to cleanroom occupancy states that utilizes the ISO 14644 series of standards but places particle and microbial limits assigned to each grade based upon the occupancy state of each grade.

Additionally the qualification testing of cleanrooms in Annex 1 calls for very specific testing such as:

  • Installed filter leakage and integrity testing.
  • Airflow measurement - Volume and velocity.
  • Air pressure difference measurement.
  •  Airflow direction and visualisation.
  • Microbial airborne and surface contamination.
  • Temperature measurement.
  • Relative humidity measurement.
  • Recovery testing.
  • Containment leak testing.

This 3-hour module will address:

  • Cleanroom concepts
  • Cleanroom and barrier system integration
  • Door openings and ingress of contamination
  • Passthrough designs
  • Airflow disruptions due to to inadequate cleanroom design
  • Case studies and regulatory observations related to cleanroom flaws that have led to environmental monitoring excursions, media fill failures, product failures, regulatory observations, warning letters , import alerts and patient harm.

Pricing:

Member Regular: $225
Nonmember Regular: $285
CEUs: .3

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Practical Considerations for Implementing a GMP Annex 1 CCS - Cleaning And Disinfection

This module provide a roadmap to the cleaning and disinfection process by covering current industry trends, global regulatory expectations, and essential elements needed to keep the cleanroom in a state of continuous control.  The current draft 12 of Annex 1 related to cleaning and disinfection includes RABS cleaning, drain cleaning, pass thru decon, disinfectant rotation, and residue removal which will all be covered.   Cleaning and disinfection are a critical component of a successful contamination control strategy.  There will be an in-depth discussion on current industry regulations.  Sanitizers, disinfectants and sterilant technologies, operator safety, and applications of these products will be discussed.   Videos will be shown to cover the usage and effective application techniques with these products. Current industry trends in disinfectant rotation, biocidal sterility, application techniques, SOP development, and rinsing and residue removal will be discussed.  Regulatory expectations of FDA, MHRA, ANVISA, ANMAT, HPRA, EMA, IFM, and ANSM inspectors will be discussed.  The current draft version 12 of Annex I, USP 43 <1072>, PDA Technical Report #70, IEST-RP-CC-018.5, and other industry related guidance documents will be covered.  The attendees will gain a stronger understanding of current industry trends regarding cleaning and disinfection best practices and how to design an effective risk-based contamination control strategy. Recent industry FDA Warning Letters, FDA 483’s, and case studies will be covered as teaching tools.

Pricing

Member: $98
No-member: $150
CEUs: .1

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Practical Considerations for Implementing a GMP Annex 1 CCS - Personnel

This comprehensive module on “Personnel” has been developed to meet the requirements as highlighted in the revision of GMP Annex 1 as part of the  Contamination Control Strategy.

  • Overview of contamination generated or brought in by personnel into the cleanrooms. 
  • Guidance on development of gown choice and management program to ensure integrity of garments and protection of product.
  • Goggle choice and management for controlling personnel borne contamination of open product.
  • Importance of glove choice and gloving procedures as a part of CCS.
  • Gowning procedures, best practices and common mistakes.
  • Training, qualification and disqualification of personnel.
  • Managing and analyzing personnel monitoring data.
  • Using of airflow visualization as a pert of qualification and training of aseptic personnel as required per GMP Annex 1 and current regulatory thinking.

Pricing

Member: $98
No-member: $150
CEUs: .1

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Practical Considerations for Implementing a GMP Annex 1 CCS - Radiation Processes and Dose Settings

This module will cover the following:

  • Overview of sterilization
  • Traditional sterilization methods
  • Dry Heat
  • Moist Heat
  • Radiation (Gamma E Beam and X Ray)
  • EO (traditional and SEO)

It will also describe and compare the three Ionizing radiation processes (Gamma, E Beam and X-ray and includes how each is delivered, areas of use, benefits and limitations, availability and guidance in references and standards on validation of sterilization doses to make a claim for terminal product sterilization. 

Defining and comparing Gamma, Electron Beam and X-ray irradiation will be discussed with this additional information:

  • How they are produced
  • Comparison of key function properties
  • Benefits of Ionizing processes
  • Reference and Guidance Standards that apply
  • Dose setting Process for a Sterility Assurance Claim
  • Considerations in deciding to use radiation processes
    • Materials effects
    • Validation time
    • Maintaining a validation with audits

Pricing:

Member: $98
No-member: $150
CEUs: .1

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Practical Considerations for Implementing a GMP Annex 1 CCS - Viable Monitoring

This comprehensive module on “Viable Monitoring” has been developed to meet the requirements as highlighted in the revision of GMP Annex 1 as part of the  Contamination Control Strategy.

  • Choice of viable monitoring equipment.
  • Media choice and management.
  • Incubation time and temperature.
  • Setting up alert and action levels.
  • Frequency of monitoring.
  • How to set up risk-based monitoring sites using airflow visualization per Annex 1 requirements.
  • Viable monitoring for performance qualification and routine monitoring.
  • Microbial identification; how and how much.
  • Personnel monitoring.
  • Monitoring of process gases.
  • Development and review of EM trend reports.

Pricing:

Member: $98
No-member: $150
CEUs: .1

Click here to purchase

 

*Note: These recordings have been unedited and some have been recorded live. Refunds will not be giving for recording quality.