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Validation of Complex Cell-Based Potency Methods
Gwen Wise Blackman
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.
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Bioavailability and Bioequivalence Studies submitted in NDAs and INDs
Stephanie Cooke
90 Min
Product Id: 705506
Attendees that need to perform bioavailability (BA) and bioequivalence (BE) studies for INDs, NDAs or for NDA supplements should attend this training. They will learn the requirements of such studies, per 21 CFR 320 and all other relevant regulatory documents.
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How to Select and Manage Vendors in a Regulated Environment (incl. ICH E6)
Angela Bazigos
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?
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Risk Based Approach in cGMP - Quality Risk Management (QRM)
Shana Dressel
60 Min
Product Id: 705412
This webinar will cover FDA’s current thinking on QRM and Guidance for Industry - Q9 Quality Risk Management, provide information to help understanding of QRM concepts, and applications. In addition, brief review of how ICH Q8, Q9, and Q10 work in coherence throughout product lifecycle.
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Tests for Outliers
Steven Wachs
60 Min
Product Id: 704404
This training program will address when to exclude outlying data points from an analysis. It will illustrate how best to apply sensitivity analysis to determine the impact of removing data. Participants will learn to perform and interpret hypothesis tests for outlier detection.
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Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects
John R Godshalk
60 Min
Product Id: 704841
This webinar will cover what is important in facility design from the FDA and regulatory standpoint. You will understand what FDA looks for during a facility inspection. You will be able to minimize possible design errors which are difficult and expensive to fix post-build. Understand what FDA looks for in reviewing the facility design and the flow patterns.
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The Revised Total Coliform Rule (RTCR)
Michael Brodsky
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.
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Vendor Qualification for Quality Services
Todd Graham
60 Min
Product Id: 705285
This webinar will teach you how and when to implement complimentary activities to an outsourced quality function and how to integrate this information into a fully-functioning program.
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FDA vs Health Canada
Rachelle D Souza
60 Min
Product Id: 704862
This webinar will provide an understanding of the organizational hierarchy of FDA and Health Canada, your regulatory and quality compliance obligations and the implications of the interactions between these two agencies on your organization.
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Bio-Relevant Drug Dissolution Testing: A New Simple and Practical Approach
Saeed Qureshi
120 Min
Product Id: 705256
This training program will highlight the current difficulties in conducting the dissolution tests, and then providing a simple and practical solution so that products could be evaluated appropriately and efficiently.
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Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing
Henry Urbach
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.
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Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
Joy McElroy
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.
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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.
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Use of SPC in the Biopharmaceutical industry: use and implementation
Jeffrey Staecker
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.
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Quality Control for Microbiological Media and Reagents
Todd Graham
60 Min
Product Id: 705060
This webinar will give you the tools you need to maintain a quality supply of media and reagents in a variety of microbiology laboratories. A thorough understanding of the variety of challenges necessary in maintain quality media and reagents will be brought to the fore. This will allow you to perform microbiology testing with confidence.
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Performing an Effective Out-of-Specification Result Investigation
Charity Ogunsanya
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.
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Strategies to Conduct a Successful Method Transfer according to FDA Expectations
Kim Huynh-Ba
90 Min
Product Id: 705059
This webinar discusses how to execute meaningful Method Transfers by selecting appropriate analytical performance characteristics and acceptance criteria, documentation of the transfer process and how to avoid failures.
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Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production
Henry Urbach
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.
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Risk-based Approach to Biopharmaceutical Method Transfers
Jeffrey Staecker
60 Min
Product Id: 705049
This Webinar will discuss how non-compendial biopharmaceutical analytical method transfers can leverage a risk-based approach to address Quality and Regulator concerns. Method transfers using a statistical equivalence approach with tight criteria as frequently suggested by regulators makes it difficult to transfer methods and can result in a high transfer failure rate.
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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.