WEBINARS

 

Bio Technologies and Processes Regulatory Compliance Training - Live Webinars, Recordings & CDs

How to Implement the FDA SUPAC Guidance

webinar-speaker   Michael Levin

webinar-time   60 Min

Product Id: 704312

This webinar training will cover various topics on Scale-Up and Post-Approval Changes (SUPAC). Participants will learn how to properly scale-up or scale-down pharmaceutical batch process and learn the standard set of documentation to successfully support post-approval changes.

18 / Nov / 2021 - Thursday

* Per Attendee $199

 

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

webinar-speaker   Joy McElroy

webinar-time   120 Min

Product Id: 704531

This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.

Recording Available

* Per Attendee $349

 

Product Stability Testing Program - Designing and Sustaining New and Existing Programs

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 703000

This life science product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.

Recording Available

* Per Attendee $299

 

Automating Assays for Clinical Diagnostics

webinar-speaker   Todd Graham

webinar-time   60 Min

Product Id: 703268

This webinar on automating laboratory assays will teach you how to translate an assay that is performed manually to one that is fully automated, with high quality and with proper validation and quality assurance for regulatory purposes.

Recording Available

 

Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)

webinar-speaker   Steven Wachs

webinar-time   90 Min

Product Id: 705020

This webinar discusses methods for estimating process capability for both normal and non-normal data. Methods include estimating the proportion of defective products that may be produced as well as the calculation and use of common process capability indices (e.g. Cpk and Ppk). Process Capability assessments are discussed in the overall context of quality improvement/management.

Recording Available

* Per Attendee $299

 

Scale-Up, Cycle Transfer, and Maximum Throughput Capability for Lyophilized Products

webinar-speaker   J. Jeff Schwegman

webinar-time   90 Min

Product Id: 702893

This training on lyophilization cycles will cover the process of transferring and or scaling-up a lyophilization process to a larger or different freeze-dryer. It will discuss a methodical approach to understand the thermal properties of a product and simplify the scale-up or transfer process resulting in a consistent product being produced in any freeze-dryer.

Recording Available

* Per Attendee $299

 

Lyophilization Process Development and Cycle Design with a Case Study

webinar-speaker   J. Jeff Schwegman

webinar-time   90 Min

Product Id: 701961

This webinar on Lyophilization Process Development and Cycle Design will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle.

Recording Available

* Per Attendee $299

 

Pre-Formulation and Formulation Development of Small and Large Molecules for a Lyophilized Product

webinar-speaker   J. Jeff Schwegman

webinar-time   90 Min

Product Id: 702305

This webinar on lyophilization technology will provide you the understanding physical properties of formulated products through the use of very specialized analytical techniques. Also attendees will learn pre-formulation assessment, pre-formulation studies including choosing an optimal solution pH and buffer system, solubility enhancement, controlling oxidation, and bulking agents.

Recording Available

* Per Attendee $249

 

Container Closure Systems for Liquid and Lyophilized Products

webinar-speaker   J. Jeff Schwegman

webinar-time   60 Min

Product Id: 702082

This webinar will discuss various container closure systems that are available for use with liquids and lyophilized products, the components that constitute a container closure system and also cover specialized delivery systems.

Recording Available

* Per Attendee $299

 

QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and Transfer

webinar-speaker   Gregory Martin

webinar-time   90 Min

Product Id: 703644

This training on using the QbD approach to analytical method lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements. The webinar presenter will use case studies to illustrate each stage in the process.

Recording Available

* Per Attendee $299

 

Data Governance for Computer Systems Regulated by FDA

webinar-speaker   Carolyn Troiano

webinar-time   60 Min

Product Id: 704745

In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.

Recording Available

* Per Attendee $249

 

Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training

webinar-speaker   Gwen Wise Blackman

webinar-time   180 Min

Product Id: 705019

This 3 hour virtual training will provide an overview of the concepts and types of immune responses elicited by biologics. The factors contributing to immunogenicity and impact on efficacy and safety will be identified. Validated screening and confirmatory methods that measure an immune response to a biologic during the various stages of development, clinical studies and post-approval surveillance will be discussed.

Recording Available

* Per Attendee $349

 

Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 704848

A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records / signature V&V as well. This training program will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing cloud environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects.

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

 

Validation of Complex Cell-Based Potency Methods

webinar-speaker   Gwen Wise Blackman

webinar-time   60 Min

Product Id: 705172

Some cell-based methods are multifaceted. This webinar will address development and validation of complex cell-based methods. It will discuss the selection of the method and the cell line, correlating the method with the pharmaceutical activity, the need for orthogonal methods, and the timeline for method validation.

Recording Available

* Per Attendee $249

 

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

 

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

 

Use of SPC in the Biopharmaceutical industry: use and implementation

webinar-speaker   Jeffrey Staecker

webinar-time   60 Min

Product Id: 705074

The webinar will describe application of SPC in manufacturing and QC and how to integrate SPC into the Quality System.

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

 

 

 

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