WEBINARS

 

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

How to Prepare a Standard Operating Procedure (SOP)?

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705131

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.

Recording Available

* Per Attendee $299

 

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

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 703875

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.

Recording Available

* Per Attendee $299

 

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

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 703885

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.

Recording Available

* Per Attendee $299

 

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

webinar-speaker   Gerry O Dell

webinar-time   60 Min

Product Id: 703288

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.

Recording Available

* Per Attendee $299

 

Basics of Testing Associated with Sterilization Validation and Routine Processing

webinar-speaker   Gerry O Dell

webinar-time   60 Min

Product Id: 701330

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.

Recording Available

* Per Attendee $299

 

Ethylene Oxide (EO) Sterilization Basics for R&D Engineers

webinar-speaker   Gerry O Dell

webinar-time   90 Min

Product Id: 701272

This Sterilization training will provide valuable information to companies that design products for terminal sterilization with ethylene oxide.

Recording Available

* Per Attendee $299

 

Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements

webinar-speaker   John Chapman

webinar-time   60 Min

Product Id: 700831

This training program will explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.

Recording Available

* Per Attendee $299

 

Process Challenge Device Development for EO Sterilization

webinar-speaker   Gerry O Dell

webinar-time   90 Min

Product Id: 703443

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.

Recording Available

* Per Attendee $299

 

Gaining and Re-establishing Control of Your Cleanroom

webinar-speaker   Joy McElroy

webinar-time   60 Min

Product Id: 705317

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.

Recording Available

* Per Attendee $249

 

FDA Inspections: What Regulations Expect

webinar-speaker   Joy McElroy

webinar-time   90 Min

Product Id: 705346

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.

Recording Available

* Per Attendee $249

 

Contamination Control in Pharmaceutical, Biotech and Medical Device Cleanroom

webinar-speaker   Jim Polarine

webinar-time   90 Min

Product Id: 705078

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.

Recording Available

 

Basic Concepts of Sterility Assurance

webinar-speaker   Mark Seybold

webinar-time   90 Min

Product Id: 705046

This course will provide a foundation for developing your technical skills related to sterility assurance.

Recording Available

 

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

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 705008

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.

Recording Available

 

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

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 704587

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.

Recording Available

* Per Attendee $229

 

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

webinar-speaker   Marisel Ortiz

webinar-time   60 Min

Product Id: 701452

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.

Recording Available

* Per Attendee $229

 

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

webinar-speaker   Marisel Ortiz

webinar-time   60 Min

Product Id: 701616

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.

Recording Available

* Per Attendee $299

 

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

webinar-speaker   Lisa Foster

webinar-time   60 Min

Product Id: 702187

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.

Recording Available

* Per Attendee $299

 

Sterilization Options for Challenging Products

webinar-speaker   Gerry O Dell

webinar-time   60 Min

Product Id: 701928

Attend this webinar to understand various sterilization processes and their general compatibility to various types of challenging medical products.

Recording Available

* Per Attendee $299

 

Gamma Sterilizer Validation: Method 1 and VDmax25 per ISO 11137

webinar-speaker   Mark Dott

webinar-time   60 Min

Product Id: 701255

This Sterilization validation training will review the general requirements for validation as described in ISO 11137:2006.

Recording Available

* Per Attendee $299

 

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

webinar-speaker   Gerry O Dell

webinar-time   80 Min

Product Id: 701680

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.

Recording Available

* Per Attendee $299

 

 

 

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