WEBINARS

 

Biotechnology Contamination Control Regulatory Compliance Training - Live Webinars, Recordings & CDs

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.

7 / Dec / 2021 - Tuesday

* Per Attendee $249

 

Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates

webinar-speaker   Travis Austin MacKay

webinar-time   90 Min

Product Id: 702154

This training will review the dietary supplement regulations in the USA and explain how to verify that your products are compliant with the most recent regulations and provisions. It covers the FDA regulatory structure and considerations for manufacturing, labeling and advertising dietary supplements.

Recording Available

* Per Attendee $279

 

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

 

Understanding Aseptic Technique and Cleanroom Behavior

webinar-speaker   Danielle DeLucy

webinar-time   60 Min

Product Id: 704429

This training program will discuss how, in sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It provides sterility, safety, and efficacy to the sterile product, especially various injections for patients. In this course, cleaning, gowning and proper methods of contamination control will be reviewed along with why clean rooms are designed the way they are.

Recording Available

* Per Attendee $299

 

Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing

webinar-speaker   Joy McElroy

webinar-time   90 Min

Product Id: 705929

In this cleaning validation webinar attendees will learn the Total Organic Carbon (TOC) feasibility, method validation and transfer from the laboratory to the manufacturing floor, as well as reviewing a feasibility study of multiple, difficult to oxidise or low solubility organic compounds.

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

 

Understanding and Controlling Endotoxin in Water Systems

webinar-speaker   T.C Soli

webinar-time   60 Min

Product Id: 701301

This Water system compliance training cover all these issues and more so that the attendee can have a better appreciation of the endotoxin test, a better understanding of what can go wrong in WFI systems to allow endotoxin into the finished water.

Recording Available

* Per Attendee $249

 

Water System Investigation "How-To's" and Example Case Studies

webinar-speaker   T.C Soli

webinar-time   90 Min

Product Id: 701585

In this Water System Webinar the author will explain the process he uses as a consultant for investigating and solving water system or product contamination problems with water organisms. Case studies of real life problems he has resolved will be presented to illustrate the process.

Recording Available

* Per Attendee $249

 

Remediating Water System Biofilm - What to Do After It Gets Ahead of You

webinar-speaker   T.C Soli

webinar-time   90 Min

Product Id: 702860

This pharmaceutical water systems webinar training will discuss what you should do when your monitoring data tells you that you may have a significant biofilm problem. It covers how to verify that the data and your interpretation of the data are correct, as well as the location of the problem which gives you clues as to what caused the problem and its impact on manufacturing and product.

Recording Available

* Per Attendee $249

 

Solutions for Addressing Fungal and Bacterial Spore Outbreaks in Pharmaceutical, Biotech, and Medical Device Operations

webinar-speaker   Jim Polarine

webinar-time   90 Min

Product Id: 701766

This webinar on addressing fungal and bacterial spore outbreaks will discuss case studies on excursion investigations and show how facility design, personnel practices and cleaning and disinfection effect excursion investigations.

Recording Available

* Per Attendee $229

 

Bacterial Endotoxin Test to Include the Latest on Low Endotoxin Recovery (LER)

webinar-speaker   Barry A Friedman

webinar-time   90 Min

Product Id: 705433

The webinar will review the current testing requirements as defined in the new, revised FDA guidance on Endotoxin and Pyrogen testing. It will further help attendees understand the issues surrounding the Low Endotoxin Recovery (LER) and its regulatory outcome.

Recording Available

 

Troubleshooting Microbial Excursions in Pharmaceutical and Biotech Operations

webinar-speaker   Jim Polarine

webinar-time   90 Min

Product Id: 701022

This webinar will discuss the details of specific excursion investigation for outbreaks of molds, vegetative bacteria, and Bacillus.

Recording Available

* Per Attendee $249

 

The Revised Total Coliform Rule (RTCR)

webinar-speaker   Michael Brodsky

webinar-time   60 Min

Product Id: 705279

This training program will discuss in detail the requirements of Revised Total Coliform Rule (RTCR) including its history and background, key provisions, comparison with the TCR (Total Coliform Rule) and much more. It will also describe the best practices to comply with the RTCR requirements.

Recording Available

 

Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing

webinar-speaker   Henry Urbach

webinar-time   90 Min

Product Id: 703474

This webinar will enable participants to understand sources of contamination and to investigate various contamination issues in the biopharmaceutical manufacturing of sterile and non-sterile products. Learn how to create an effective Environmental Monitoring (EM) program.

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

 

Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

webinar-speaker   Henry Urbach

webinar-time   90 Min

Product Id: 705072

This webinar you will discuss how to help your organization get a better handle on what is an “objectionable microorganism, ” exactly how “objectionable” it really is and what you can do to minimize the risk if you find one in your process or product.

Recording Available

* Per Attendee $249

 

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

 

Designing an Effective and Compliant Standard Operating Procedure (SOP) and Standard Test Method (STM)

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 705018

This webinar training will benefit manufacturers of manufactured products to achieve an effective, robust and compliant SOP and STM which will result in a cost effective and efficient manufacturing and testing of products. A well planned and written SOP or STM will reduce the incidence of out-of-specification (OOS) results, failure, product non-conformances, deviation and invalid assay investigations.

Recording Available

 

Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?

webinar-speaker   Henry Urbach

webinar-time   90 Min

Product Id: 703058

This webinar on biopharmaceutical raw material testing will discuss how to implement processes for the control of microbial contamination, establish microbial limits and mitigate the risk of contamination.

Recording Available

* Per Attendee $199

 

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

 

 

 

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