On Demand Webinars
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Recording
Risk Management in GMP Facilities
Description: This FDA GMP training will help you understand the current requirements for raw material management with tips for practical implementation. It covers FDA’s expectations from GMP facilities regarding raw material vendor selection, measures for assuring acceptable quality of... -
Recording
Marketing FDA Regulated Products Through Social Media
Description: The seminar will discuss the do’s and don’ts for using social media in marketing FDA-regulated products. Common issues, misconceptions, perceptions, and possible solutions will be discussed. In a social media rich environment, manufacturers cannot avoid information dissemination via... -
Recording
How to Comply with FDA’s Off-Label Promotion Guidelines
Description: Many FDA approved products have uses beyond what they have been approved for. Manufacturers have to follow very strict guidelines to inform physicians about these additional uses. Manufacturers also have to deal with consumers directly asking for more... -
Recording
FDA Expectations from 505(b)(2) Product Development Pathway
Description: A 505(b)(2) product is an improved or altered version or a new use application for a previously FDA-approved drug. This unique regulatory pathway, available only for marketing approval in the US, offers an attractive pathway to cheaper and... -
Recording
The Hybrid Pharmaceutical GMP Quality System – From API To Final Dosage
Description: Does your company need two GMP quality systems – one for API and one for finished products? Your answer is most likely “that’s the way the FDA or my regulatory body has established the GMP’s”. And that is... -
Recording
ICH Q 10 Product Lifecycle
Description: This 90 minute webinar will give you the necessary guidance on the ICH Q 10 Product Lifecycle – From Concept to Ensuring User/Patient Satisfaction. The Product Lifecycle concept is certainly not new and has been practiced and observed... -
Recording
Current GMP Requirements for Combination Products – Final Rule
Description: As you know, medical diagnosis, technology, and treatment is very dynamic and is rapidly advancing. New discoveries are made that do not fit the “regulatory mold “and thus require new approaches to regulation. Combination products is one such... -
Recording
ICH Q10 Pharmaceutical Quality System
Description: ICH Q10 is particularly important because the USA, Canada, Europe, and Japan have announced their intentions to adopt the ICH Q10 guidance. Therefore, it is necessary to understand and comply with this guidance in order to market your... -
Recording
Proactive Internal Auditing-The Key to Establishing, Maintaining, and Improving Quality Systems
Description: This webinar provides a broad overview of the internal auditing functions starting with the concept of quality systems and their objectives, primarily using graphical methods. The webinar focuses on the role of the internal audit function throughout the... -
Recording
How to select Software for a Regulated Environment
Description: Software is widely used in our industry and selection of new software or upgrade of existing software is one of the activities that crop up every year in an IT department’s task list. Our industry, has the added... -
Recording
FDA’s 21 CFR Part 11 Add-on Inspections
Description: In December 2010 the FDA began a project to better understand the industry’s adherence (or lack thereof) to 21 CFR Part 11. This involves the add on’ surveillance inspections of the sponsors’ computer systems during the course of... -
Recording
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
Description: This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin... -
Recording
21 CFR 11 Compliance for Excel Spreadsheets
Description: In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional findings. Spreadsheet Applications such as MS Excel are frequently used in 21 CFR... -
Recording
Pharmaceutical Quality Management System – Applying the Principles of Lean Documents and Lean Configuration
Description: The Theory of Lean Documents is the product of applying lean principles to the Quality Management System (QMS) documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and “push” systems, many traditional document... -
Recording
U.S. FDA’s Strategic Priorities – 2014 and Beyond
Description: This webinar will examine the FDA’s recently instituted annual “Strategic Priorities” initiative, with emphasis on 2014, and future issues. Such a review will focus on the broad range of issues a company’s senior management and QA/RA need to...
