WEBINARS

 

Biotechnology Products Testing and Validation 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.

Recording Available

* Per Attendee $299

 

Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

webinar-speaker   Joy McElroy

webinar-time   120 Min

Product Id: 704086

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.

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

 

Steam Sterilization Microbiology and Autoclave Performance Qualification

webinar-speaker   Danielle DeLucy

webinar-time   60 Min

Product Id: 705027

In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.

Recording Available

* Per Attendee $299

 

Implementation and Management of GMP Data Integrity

webinar-speaker   Danielle DeLucy

webinar-time   90 Min

Product Id: 705029

Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.

Recording Available

* Per Attendee $299

 

Bioanalytical Methods Validation

webinar-speaker   Edward O Connor

webinar-time   60 Min

Product Id: 701769

This training on bio-analytical methods validation will help you to understand the FDA and EMA guidance for Instrumental, ligand binding and cell-based assays and also review of recent 483s impacting validation.

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

 

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

 

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

 

Assay Validation for Clinical Diagnostics

webinar-speaker   Todd Graham

webinar-time   60 Min

Product Id: 702872

This training on assay validation will teach you how to validate an assay for clinical diagnostics and transition the assay into the clinical laboratory for diagnostic use.

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

 

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

 

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

 

How to Select and Manage Vendors in a Regulated Environment (incl. ICH E6)

webinar-speaker   Angela Bazigos

webinar-time   90 Min

Product Id: 705488

Buying software is a fact of life for most companies. There is fierce competition in the market, with multiple software vendors trying to convince to buy their product. How do you determine whether to buy the software or having it built in house? Or which vendor to choose? And if you buy something, how do you determine whether to have it hosted? And are there any regulations that apply to this software? And if so, what are they?

Recording Available

 

Method Validation: Yesterday, Today and Tomorrow

webinar-speaker   Steven Walfish

webinar-time   60 Min

Product Id: 705439

This webinar will focus on analytical method validation and its evolution to be a risk based process using statistical concepts. The idea of an Analytical Target Profile (ATP) in the context of target measurement uncertainty (TMU) will be explored.

Recording Available

* Per Attendee $279

 

Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach

webinar-speaker   Joy McElroy

webinar-time   90 Min

Product Id: 704306

This 90-minute training program is designed for people tasked with performing external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have quality management system responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes and documentation.

Recording Available

* Per Attendee $299

 

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

 

Performing an Effective Out-of-Specification Result Investigation

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 705064

This webinar will provide the basic understanding of how to conduct a compliant and effective out-of-specification (OOS) result investigation which is critical in preventing product recalls, voluntary and involuntary plant shut down, and FDA 483 findings or warning letter. It will also provide a basic mainframe for the Quality Assurance unit in the final disposition of the affected finished product as well as provide guidance for the different types of OOS investigational systems.

Recording Available

 

 

 

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