ComplianceOnline

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

Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training
19
/ Dec
Wednesday-2018

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

  • Speaker: Gwen Wise Blackman
  • Product ID: 705019
  • Duration: 180 Min
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.
* Per Attendee
$299
Data Governance for Computer Systems Regulated by FDA
23
/ Jan
Wednesday-2019

Data Governance for Computer Systems Regulated by FDA

  • Speaker: Carolyn Troiano
  • Product ID: 704745
  • Duration: 60 Min
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.
* Per Attendee
$199
Process Capability for Normal and Non-Normal
13
/ Feb
Wednesday-2019

Process Capability for Normal and Non-Normal

  • Speaker: Steven Wachs
  • Product ID: 705020
  • Duration: 90 Min
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.
* Per Attendee
$199
Recorded/CD
Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

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

  • Speaker: John E Lincoln
  • Product ID: 704848
  • Duration: 90 Min
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.
CD/Recorded
$249
Recorded/CD
Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

  • Speaker: Joy McElroy
  • Product ID: 704531
  • Duration: 120 Min
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.
CD/Recorded
$249
Recorded/CD
Remediating Water System Biofilm - What to Do After It Gets Ahead of You

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

  • Speaker: T.C Soli
  • Product ID: 702860
  • Duration: 90 Min
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.
CD/Recorded
$249
Recorded/CD
Product Stability Testing Program - Designing and Sustaining New and Existing Programs

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

  • Speaker: Charity Ogunsanya
  • Product ID: 703000
  • Duration: 90 Min
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.
CD/Recorded
$249
Recorded/CD
Validation of Complex Cell-Based Potency Methods

Validation of Complex Cell-Based Potency Methods

  • Speaker: Gwen Wise Blackman
  • Product ID: 705172
  • Duration: 60 Min
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.
CD/Recorded
$249
Recorded/CD
Troubleshooting Microbial Excursions in Pharmaceutical and Biotech Operations

Troubleshooting Microbial Excursions in Pharmaceutical and Biotech Operations

  • Speaker: Jim Polarine
  • Product ID: 701022
  • Duration: 90 Min
This webinar will discuss the details of specific excursion investigation for outbreaks of molds, vegetative bacteria, and Bacillus.
CD/Recorded
$249
Recorded/CD
Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing

Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing

  • Speaker: Henry Urbach
  • Product ID: 703474
  • Duration: 90 Min
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.
CD/Recorded
$249
Recorded/CD
QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and Transfer

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

  • Speaker: Gregory Martin
  • Product ID: 703644
  • Duration: 90 Min
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.
CD/Recorded
$249
Recorded/CD
Use of SPC in the Biopharmaceutical industry: use and implementation

Use of SPC in the Biopharmaceutical industry: use and implementation

  • Speaker: Jeffrey Staecker
  • Product ID: 705074
  • Duration: 60 Min
The webinar will describe application of SPC in manufacturing and QC and how to integrate SPC into the Quality System.
Recorded/CD
Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

  • Speaker: Henry Urbach
  • Product ID: 705072
  • Duration: 90 Min
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.
CD/Recorded
$249
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
Designing an Effective and Compliant Standard Operating Procedure (SOP) and Standard Test Method (STM)

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

  • Speaker: Charity Ogunsanya
  • Product ID: 705018
  • Duration: 90 Min
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.
Recorded/CD
Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?

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

  • Speaker: Henry Urbach
  • Product ID: 703058
  • Duration: 90 Min
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.
CD/Recorded
$199
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
Understanding and Remediating Corrosion Problems during Parenterals Manufacturing

Understanding and Remediating Corrosion Problems during Parenterals Manufacturing

  • Speaker: Barrett Rabinow
  • Product ID: 704983
  • Duration: 2 hrs
In this two-hour webinar you will learn how to recognize problems related to corrosion, how to diagnose their specific causes, and how to remediate them. This webinar surveys the range of corrosion-mediated failure modes of parenteral solution manufacture. The roles of physical factors such as temperature, humidity, oxygen as well as formulation variables such as chloride level, pH, and inorganic metals will be discussed in this session.
Recorded/CD
You Found an Objectionable Microorganism, Now What? Risk of presence of Objectionable Microorganisms in Biopharmaceuticals

You Found an Objectionable Microorganism, Now What? Risk of presence of Objectionable Microorganisms in Biopharmaceuticals

  • Speaker: Henry Urbach
  • Product ID: 702964
  • Duration: 60 Min
This webinar on objectionable microorganisms will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.
CD/Recorded
$229
Recorded/CD
4-Hr Virtual Training: Key Factors to Write an Effective Standard Operating Procedure and Work Instructions

4-Hr Virtual Training: Key Factors to Write an Effective Standard Operating Procedure and Work Instructions

  • Speaker: Joy McElroy
  • Product ID: 704778
  • Duration: 4 hrs
This training program will guide attendees in writing effective Standard Operating Procedures and Work Instructions. It will also discuss how to assess and write to the audience and how to review and revise SOPs and Work Instructions.
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