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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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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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Subcontractor auditing (cGMP/Pharma/Med device industries)
Jan Warner
90 Min
Product Id: 705063
This course will describe the basic principles and requirements for building a supplier audit program. This webinar will provide a framework on which to build your subcontractor auditing program.
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Packaging and Labeling for Commercial and Clinical Products
Peggy Berry
90 Min
Product Id: 704378
This training program will discuss optimizing your packaging design for commercial and clinical products and translating a protocol into effective packaging design. Attendees will learn how to implement an effective artwork change management system. Real-life case studies and dos/don’ts for packaging and labeling for commercial and clinical products will also be discussed.
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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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Implementing a Modern Pharmaceutical Quality System
Steven Laurenz
60 Min
Product Id: 705055
This presentation explores the basic concepts making up an ICH Q10 Quality System approach and steps to properly implement the concepts.
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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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Compliance with Brexit's Impact on the Global Pharmaceutical industry
Laura Brown
60 Min
Product Id: 705047
Pharmaceutical companies will need to develop strategies for their drug programmes to deal with Brexit. This webinar will provide an essential understanding to help develop a strategy for managing Brexit.
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Quality by Design
Heath Rushing
60 Min
Product Id: 705051
This training program will guide attendees in implementing QbD principles from discovery through product discontinuation. It will also illustrate applying statistics to set specifications and validate measurement systems (assays) and discuss utilizing risk management tools to identify and prioritize potential critical process parameters.
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TSCA Reform - Immediate Actions Required
Rose Passarella
60 Min
Product Id: 705036
This webinar will provide an overview of the new law and major changes to Toxic Substances Control Act (TSCA). All chemical stakeholders doing business in the U.S. will need to understand the fundamental shifts in requirements, the new concepts and approaches that are introduced by the law, and the timetable that the U.S. Environmental Protection Agency (EPA) must follow in implementing the new law.
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Moving FDA Boundaries for Direct-to-Consumer Advertising
Casper Uldriks
90 Min
Product Id: 705033
FDA encourages companies that offer DTC advertising to include accurate information in their ads. Through a comprehensive surveillance and enforcement program, the agency ensures that consumers are not misled or deceived by advertisements that violate the law. This webinar will bring attendees up to speed so you are clearer about when DTC advertising makes you ripe for legal picking by the FDA.
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Perceptions of The Health Risks of Cosmetics, and What it means to Their Regulation
Rob Ross Fichtner
90 Min
Product Id: 704955
This webinar will discuss some of the major issues in the regulation of cosmetics. Upon completion of the session attendees will learn how regulators regulate cosmetics compared to other categories, fine line between cosmetics and drugs, and future directions for cosmetic regulations.
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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.
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Designing an Effective and Compliant Standard Operating Procedure (SOP) and Standard Test Method (STM)
Charity Ogunsanya
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.
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Tools for Human Error Reduction
Ginette M Collazo
90 Min
Product Id: 704364
This training program will analyze the factors and causes behind human errors. It will define the process to manage human error deviations and participants will learn about human error measurement. The program will also discuss tools for measurement and Key Performance Indicators (KPIs).
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Applying Statistical Process Control Effectively
Steven Wachs
60 Min
Product Id: 701994
This training will help you gain a solid understanding of what Statistical Process Control (SPC) is and what it isn’t. We will discuss the common misunderstanding and misapplications of SPC so that you may avoid them.
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Prospects for Change at FDA Under the Trump Administration: Early View of What 2017 Will Bring
Steven Grossman
90 Min
Product Id: 705023
This webinar will discuss FDA's current priorities and the agency's likely priorities and the future of regulations and policies in 2017 under the new Trump administration.
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Project Risk Management
Mario Mosse
90 Min
Product Id: 705015
Project risk management includes the processes of conducting risk management planning, identification, analysis, action planning, and controlling risk on a project. This training program will analyze the objectives of project risk management - to increase the likelihood and impact of positive outcomes while decreasing the likelihood and impact of negative events affecting the success of the project.