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Setting Specifications for Drug Substances and Drug Products
Peggy Berry
90 Min
Product Id: 704859
This 90-minute training will discuss the requirements of ICH for using testing and stability data to set specifications for drug substances and drug products including use of special stability studies. Attendees will also learn the requirements for changing specifications through the lifecycle of the product.
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Remediating Water System Biofilm - What to Do After It Gets Ahead of You
T.C Soli
90 Min
Product Id: 702860
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.
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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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Drug Product Performance, In Vivo: Bioavailability and Bioequivalence
Leon Shargel
90 Min
Product Id: 705461
This webinar will discuss the basic concepts of bioavailability and bioequivalence and their relationship to drug product performance, in vivo. It will also provide practical examples to show how bioavailability and bioequivalence studies can be applied to drug product development.
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Good Manufacturing Practices for Active Pharmaceutical Ingredients (APIs)
Stephanie Cooke
90 Min
Product Id: 705486
This webinar will cover ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (API). Attendees will gain a deeper understanding of the importance of GMPs for APIs, apply these principles in their current roles in order to better manage quality, make improvements, solve problems and make decisions.
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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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Pharmacokinetics of Oral Absorption
Leon Shargel
90 Min
Product Id: 705458
This webinar will discuss pharmacokinetic principles of systemic drug absorption and its applications to the development of oral dosage forms. It will also provide practical examples to show how pharmacokinetics of oral absorption can be applied to drug product development.
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Cosmetic Testing for US FDA Compliance
Rachelle D Souza
75 Min
Product Id: 705450
This webinar will help attendees understand FDA recommendations and requirements concerning the safety and quality testing of cosmetics. Attendees will understand different types of cosmetic testing, when they are applicable and related compliance requirements.
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Auditor Training: Excipients and APIs
Madeleine Fairweather
120 Min
Product Id: 705438
This webinar covers the excipients and APIs regulatory requirements, audit planning and execution, basic to advanced auditing techniques, with emphasis on advancing the auditor’s people-skills, effectiveness and reporting skills.
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Commercial and HTA Policy in the UK
Leela Barham
90 Min
Product Id: 705431
This webinar will provide an understanding of the key European market’s approach to pricing including the details of Pharmaceutical Price Regulation Scheme (PPRS). It will further discuss the key issues shaping the future of HTA policy in the UK.
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Whistle While You Work: Protecting Your Organization from Whistleblower Threats
Christine Zack
60 Min
Product Id: 705413
This webinar will provide an overview of SEC Whistleblower Rules such as False Claims Act, Dodd-Frank, Sarbanes-Oxley and Commodity Exchange Act. It will also discuss best practices on how to mitigate damages from an actual or purported whistleblower.
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Predicting Plasma Drug Levels and Relevant Concepts of Convolution/Deconvolution and In Vitro-In Vivo Correlations (IVIVC)
Saeed Qureshi
120 Min
Product Id: 705280
This training program will discuss in detail the method for predicting plasma drug levels from in vitro dissolution results. It will also provide details of the underlying scientific principles involved such as convolution, deconvolution and IVIVC with simple practical examples.
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Pharmaceutical Water Systems
Carl Patterson
60 Min
Product Id: 705311
This webinar provides an overview on the different types of water systems used in the pharmaceutical industry. Attendees will be provided a comprehensive overview of the different types of water systems, their validation, and handling of excursions.
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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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Process Validation - Current Industry Practices and FDA Guidance Document Review
John R Godshalk
60 Min
Product Id: 705316
This webinar will cover basics of process validation along with current industry practices. It will also discuss recent FDA draft guidance document and the importance of good process validation.
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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.