ComplianceOnline

Medical Device Sterilization Regulatory Compliance Training - Live Webinars, Recordings & CDs

Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes
20
/ Feb
Wednesday-2019

Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes

  • Speaker: Charity Ogunsanya
  • Product ID: 703885
  • Duration: 90 Min
This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.
* Per Attendee
$199
Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements
11
/ Apr
Thursday-2019

Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements

  • Speaker: John Chapman
  • Product ID: 700831
  • Duration: 60 Min
This training program will explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.
* Per Attendee
$199
Recorded/CD
Gaining and Re-establishing Control of Your Cleanroom

Gaining and Re-establishing Control of Your Cleanroom

  • Speaker: Joy McElroy
  • Product ID: 705317
  • Duration: 60 Min
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 event.
CD/Recorded
$249
Recorded/CD
How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

  • Speaker: Charity Ogunsanya
  • Product ID: 703875
  • Duration: 90 Min
This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes.
CD/Recorded
$249
Recorded/CD
FDA Inspections: What Regulations Expect

FDA Inspections: What Regulations Expect

  • Speaker: Joy McElroy
  • Product ID: 705346
  • Duration: 90 Min
Attend this webinar to increase one’s knowledge of FDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. It will provide an in-depth understanding of how to prepare for unannounced FDA audits and inspections.
CD/Recorded
$249
Recorded/CD
How to prepare a winning Standard Operating Procedure (SOP)

How to prepare a winning Standard Operating Procedure (SOP)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705131
  • Duration: 60 Min
This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.
Recorded/CD
Contamination Control in Pharmaceutical, Biotech and Medical Device Cleanroom

Contamination Control in Pharmaceutical, Biotech and Medical Device Cleanroom

  • Speaker: Jim Polarine
  • Product ID: 705078
  • Duration: 90 Min
This 90-minute webinar will cover general considerations for microbial control for non-sterile manufacturing areas, including attributes of an effective cleaning and disinfection program. Points to consider specifically aimed at oral solid dose (OSD) manufacturers will also be presented, including cleaning and disinfection of both product contact and non-product contact surfaces.
Recorded/CD
Basics of Testing Associated with Sterilization Validation and Routine Processing

Basics of Testing Associated with Sterilization Validation and Routine Processing

  • Speaker: Gerry O Dell
  • Product ID: 701330
  • Duration: 60 Min
This sterilization validation process training webinar will review the FDA or ISO requirements for tests following validation and emphasis is placed on the appropriate tests for validation, the appropriate routine tests and the frequency of testing.
CD/Recorded
$279
Recorded/CD
Basic Concepts of Sterility Assurance

Basic Concepts of Sterility Assurance

  • Speaker: Mark Seybold
  • Product ID: 705046
  • Duration: 90 Min
This course will provide a foundation for developing your technical skills related to sterility assurance.
Recorded/CD
Understanding the Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program

Understanding the Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program

  • Speaker: Charity Ogunsanya
  • Product ID: 705008
  • Duration: 90 Min
This webinar will help the attendee gain an understanding of the requirements of current USP <85> Bacterial Endotoxin Test (BET), European Pharmacopoeia (Chapter 2.6.14) and the Japanese Pharmacopoeia (General Tests, No. 4.01). The webinar will provide the attendee the ability to understand the different LAL testing methodologies, choosing the best test method applicable to the product type, criticality of the BET test result as it applies to the release of a cGMP manufactured product.
Recorded/CD
You have a BI Positive or Product Sterility Positive - Now What?

You have a BI Positive or Product Sterility Positive - Now What?

  • Speaker: Gerry O Dell
  • Product ID: 703288
  • Duration: 60 Min
This webinar will discuss what actions should be taken following a positive result in a sterility test on a biological indicator (BI) during performance qualification or routine testing. It will also explain the various items that should be investigated to determine the root cause and the follow up to the investigation.
CD/Recorded
$279
Recorded/CD
US, EU, Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus

US, EU, Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus

  • Speaker: Robert J Russell
  • Product ID: 704587
  • Duration: 90 Min
This 90-minute webinar will help you gain a comprehensive understanding of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will prepare you for regulatory inspections in these countries.
CD/Recorded
$229
Recorded/CD
Process Challenge Device Development for EO Sterilization

Process Challenge Device Development for EO Sterilization

  • Speaker: Gerry O Dell
  • Product ID: 703443
  • Duration: 90 Min
This webinar will discuss the role of Process Challenge Devices (PCDs) both during ethylene oxide (EO) validation and during routine processing. It will explain the difference in requirements for PCD during both the processes.
CD/Recorded
$229
Recorded/CD
How to Implement Parametric Release in EO Sterilization - A Practical Approach

How to Implement Parametric Release in EO Sterilization - A Practical Approach

  • Speaker: Marisel Ortiz
  • Product ID: 701452
  • Duration: 60 Min
This webinar will present a practical approach for implementing parametric release in EO sterilization. We will discuss the cycle validation and other requirements for implementation of parametric release in EO sterilization as per EN/ISO 11135.
CD/Recorded
$229
Recorded/CD
Reducing Ethylene Oxide (EO) Sterilization Costs While Maintaining Regulatory Compliance

Reducing Ethylene Oxide (EO) Sterilization Costs While Maintaining Regulatory Compliance

  • Speaker: Marisel Ortiz
  • Product ID: 701616
  • Duration: 60 Min
In this Ethylene Oxide (EO) Sterilization training, you will learn how to evaluate your sterilization process for cost reduction/process efficiency, and also learn how to implement such changes without jeopardizing product safety and regulatory compliance.
CD/Recorded
$299
Recorded/CD
Application of CAPA in (Device) Sterilization - For the Non-Expert

Application of CAPA in (Device) Sterilization - For the Non-Expert

  • Speaker: Lisa Foster
  • Product ID: 702187
  • Duration: 60 Min
This webinar will review the typical non-conformances experienced in the (Medical Device) sterilization process and the course of action that should be taken by the manufacturer or contract sterilizer.
CD/Recorded
$299
Recorded/CD
Sterilization Options for Challenging Products

Sterilization Options for Challenging Products

  • Speaker: Gerry O Dell
  • Product ID: 701928
  • Duration: 60 Min
Attend this webinar to understand various sterilization processes and their general compatibility to various types of challenging medical products.
CD/Recorded
$299
Recorded/CD
Gamma Sterilizer Validation: Method 1 and VDmax25 per ISO 11137

Gamma Sterilizer Validation: Method 1 and VDmax25 per ISO 11137

  • Speaker: Mark Dott
  • Product ID: 701255
  • Duration: 60 Min
This Sterilization validation training will review the general requirements for validation as described in ISO 11137:2006.
CD/Recorded
$299
Recorded/CD
Developing an ethylene oxide (EO) sterilization process for a product with limitations

Developing an ethylene oxide (EO) sterilization process for a product with limitations

  • Speaker: Gerry O Dell
  • Product ID: 701680
  • Duration: 80 Min
This EO sterilization training Webinar will discuss how to modify EO sterilization process for complicated medical products which are sensitive to moisture, temperature, vacuum changes.
CD/Recorded
$299
Recorded/CD
Sterilization as a Benchmark for Cleaning Validation and Control

Sterilization as a Benchmark for Cleaning Validation and Control

  • Speaker: Anthony DeMarinis
  • Product ID: 701278
  • Duration: 60 Min
This Cleaning validation training will emphasize on interrelationships with other processes and using the information gained during validation to monitor and control the cleaning process to prevent failure.
CD/Recorded
$299
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