
How to Prepare a Standard Operating Procedure (SOP)?
Dr. Afsaneh Motamed Khorasani
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.

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation
Charity Ogunsanya
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.

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

You have a BI Positive or Product Sterility Positive - Now What?
Gerry O Dell
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.

Basics of Testing Associated with Sterilization Validation and Routine Processing
Gerry O Dell
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.

Ethylene Oxide (EO) Sterilization Basics for R&D Engineers
Gerry O Dell
90 Min
Product Id: 701272
This Sterilization training will provide valuable information to companies that design products for terminal sterilization with ethylene oxide.

Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements
John Chapman
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.

Process Challenge Device Development for EO Sterilization
Gerry O Dell
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.

Gaining and Re-establishing Control of Your Cleanroom
Joy McElroy
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.

FDA Inspections: What Regulations Expect
Joy McElroy
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.

Contamination Control in Pharmaceutical, Biotech and Medical Device Cleanroom
Jim Polarine
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.

Basic Concepts of Sterility Assurance
Mark Seybold
90 Min
Product Id: 705046
This course will provide a foundation for developing your technical skills related to sterility assurance.

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

US, EU, Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus
Robert J Russell
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.

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

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

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

Sterilization Options for Challenging Products
Gerry O Dell
60 Min
Product Id: 701928
Attend this webinar to understand various sterilization processes and their general compatibility to various types of challenging medical products.

Gamma Sterilizer Validation: Method 1 and VDmax25 per ISO 11137
Mark Dott
60 Min
Product Id: 701255
This Sterilization validation training will review the general requirements for validation as described in ISO 11137:2006.

Developing an ethylene oxide (EO) sterilization process for a product with limitations
Gerry O Dell
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.