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3-Hour Virtual Training: Lean Leadership, Quality and the Customer
Charles H Paul
180 Min
Product Id: 705109
Lean is not a quick fix for doing more with less and doing it in half the time – it is not something you undertake to realize short-term improvements – it is on the other hand, a new way of thinking about your business and a new way of executing business activities. This virtual training and the others in the series will lead you through the journey of lean from its inception through complete implementation.
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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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Putting the Quality in Audit Reports
Jonnie T Keith
90 Min
Product Id: 705066
The objective of any report is to provide important information to management in the area reviewed. It represents the end result of weeks of reviews, analyses, interviews and discussions. The quality of that report will have an impact on how well the report is understood and accepted. This training program will review the audit standards related to audit report quality and encourage attendees to participate in various quality report exercises.
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Linear Regression Analysis for Medical Device Manufacturing
Daniel O Leary
90 Min
Product Id: 705108
Analyzing processes to understand their operation and implementing improvement is a necessary element in any quality system, but is especially important in medical devices. One of the more important tools is linear regression. Using Excel, you can get the information you need for process improvement.
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Introduction to FDA and EU Medical Device Submission
Charles H Paul
60 Min
Product Id: 705065
This webinar will overview each critical aspect of the FDA submissions process to include 510(k) and PMA) and contrast those key steps to those of the EU Medical Device Directives Submissions process.
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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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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-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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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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How to prepare a 510(k) FDA Submission
Edwin Waldbusser
60 Min
Product Id: 705024
This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission.
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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.
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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).