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Drug Pharmacy Compounding
Rachelle D Souza
60 Min
Product Id: 704907
This webinar will discuss conditions under which certain compounded human drug products are exempted from compliance with cGMPs, labeling, market approval and reporting requirements. It will cover conditions that require an outsourcing facility to comply and the latest developments in drug pharmacy compounding.
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Pharmaceutical Packaging - Regulations and Testing Standards
Thomas Feinberg
90 Min
Product Id: 705305
This webinar will present the current state of US and EU (pre-Brexit) regulatory policy with some insights into the CFDA (China) related to pharmaceutical packaging and testing. A unified risk assessment strategy will be presented to guide laboratory and eventual regulatory reporting activities.
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ICH Q11 - API Manufacturing
Peggy Berry
90 Min
Product Id: 705303
The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. By the end of this program, attendees will understand the requirements of the ICH Q11 guidance and learn skills for practical implementation of those requirements.
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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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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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Creating and Maintaining an Effective and Efficient Technical Training Programs
Ginette M Collazo
90 Min
Product Id: 704373
This training program will analyze key elements of training programs in regulated environment. It will also list key performance indicators related to training and offer best practices for developing technical training programs to improve their effectiveness.
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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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Good Manufacturing Practices (GMPs) for Phase I Investigational Drugs / Clinical Studies
Peggy Berry
90 Min
Product Id: 705255
This webinar will help attendees understand differences between GMP requirements for early and later stage clinical development. It will explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.
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How to Design and Implement a Dynamic Control Plan
William Levinson
90 Min
Product Id: 705171
Learn how the FMEA and control plan can be combined to create a dynamic control plan, a living document that helps to drive continual improvement.
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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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Audits - Seven reasons they don't work
Susanne Manz
90 Min
Product Id: 705042
Continuous Improvement starts with awareness of issues and opportunities. And without an effective internal audit program, management lacks awareness of the issues within their quality system. Management is blind to the gaps in the quality system and the risk that poses for the company. Even worse, management is blind to the impact on product quality and risk to the customer. This webinar will highlight red-flags and ways reduce compliance and quality risk.