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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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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.
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Metrics and Dashboards for Quality and Compliance
Susanne Manz
90 Min
Product Id: 703928
This training program will discuss the challenges faced by medical device companies amid close scrutiny by industry regulators. It will also offer best practices for combating lack of transparency in quality/compliance data.
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Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?
Henry Urbach
90 Min
Product Id: 703058
This webinar on biopharmaceutical raw material testing will discuss how to implement processes for the control of microbial contamination, establish microbial limits and mitigate the risk of contamination.
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Understanding the Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program
Charity Ogunsanya
90 Min
Product Id: 705008
This webinar will help the attendee gain an understanding of the requirements of current USP <85> Bacterial Endotoxin Test (BET), European Pharmacopoeia (Chapter 2.6.14) and the Japanese Pharmacopoeia (General Tests, No. 4.01). The webinar will provide the attendee the ability to understand the different LAL testing methodologies, choosing the best test method applicable to the product type, criticality of the BET test result as it applies to the release of a cGMP manufactured product.
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The 21 Elements of a 510(k)
John E Lincoln
90 Min
Product Id: 702323
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product requirements and documentation necessary to file a 510(k). The 510(k), in any of its three allowable formats, with up to 21 required elements. A brief discussion of how to address device changes and when to file a new 510(k). Consideration of the U.S. FDA's current K-97-1 Memo / guidance document on 510(k) Device Modifications: Deciding When to submit a 510(k) for a Change to an Existing Device, to provide tools to document such decisions.
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Data Analysis in QSR
Daniel O Leary
90 Min
Product Id: 704990
Data analysis is one of the most powerful improvement tools because it can lead to cost reductions and preventive action. To use these techniques you need to know both the regulatory requirements and the analysis framework. This webinar gives you the tools and techniques to implement an effective data analysis program.
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Russia: Compliance Processes and Regulations
Robert J Russell
90 Min
Product Id: 703870
This training course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.
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Quality Assurance at the (Clinical Research) Site: How to Develop a Manageable Plan
Jennifer Holcomb
60 Min
Product Id: 702406
This clinical compliance training will help attendees understand how they can develop and implement a Quality Assurance (QA) program at their clinical research site that ensures the staff are properly trained and that the research is carried out in accordance with regulatory expectations.
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What is Required for RoHS2 per EN 50581, 2012?
Jim Kandler
60 Min
Product Id: 704988
This training program will discuss the manufacturer’s obligations mentioned in the EN 50581, 2012 guidance document. The topics in the guidance document will be explored from the perspective of a US manufacturer.
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Creating a Good Design History File (DHF) for Audit Success
Mercedes Massana
60 Min
Product Id: 701978
This DHF regulatory compliance training will discuss the structure of a good Design History File, elements to look for when auditing a DHF and how to address issues. It will provide the information necessary to maintain a good DHF that will help manufacturers during a regulatory compliance audit.
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You Found an Objectionable Microorganism, Now What? Risk of presence of Objectionable Microorganisms in Biopharmaceuticals
Henry Urbach
60 Min
Product Id: 702964
This webinar on objectionable microorganisms will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.
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The Investigational Medicinal Product Dossier (IMPD): EU's CTA vs. FDA's IND
Robert J Russell
90 Min
Product Id: 702030
This 90 minute webinar will help you comprehensively understand the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application.
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Life Cycle Risk Management for 21 CFR 820 and ISO 13485
Russell Pizzuto
90 Min
Product Id: 704964
This webinar will present a Lifecycle Risk Management System that meets FDA and ISO requirements. That risk management system (based on ISO 14971) creates a closed loop system that identifies risks, and uses field use feedback to adjust risks and to improve designs and processes. The objective evidence produced by a Lifecycle Risk Management Systems can be used to demonstrate risk management compliance to 21 CFR Part 820 and ISO 13485.
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FDA & CFIA 2016 Regulatory Changes/Updates Since ACE | Make Sure Your Business is Updated
Grant Smith
90 Min
Product Id: 704621
This training program will cover the 2016 regulatory changes and updates for the FDA (US Food and Drug Administration) and the CFIA (Canadian Food Inspection Agency). The program will also discuss updated product code classifications, license requirements for SFCA/CFIA, Automated Import Reference System updates and latest product marking requirements.
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Device Design and Risk Management
Daniel O Leary
90 Min
Product Id: 704561
As medical device requirements and expectations increase, coupled with strengthened standards, the design project must seek every opportunity to leverage activities in the area to satisfy requirements in other areas. This reduces the total work and helps make these processes more efficient. By attending this presentation, you will learn techniques to improve your device design project.
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Prove 21 CFR 820 Compliance Using Requirements Traceability
Russell Pizzuto
90 Min
Product Id: 704935
This webinar will demonstrate how to use requirements tractability to systematically connect Engineering, Manufacturing and Risk Management processes, and how to systematically collect the objective evidence necessary to prove 21 CFR 820 compliance to the FDA.
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Critical Elements of Quality Risk Management Relating to FDA Compliance
Danielle DeLucy
60 Min
Product Id: 704829
This training program will discuss risk management and outline the requirements for applying risk management to the quality system. It will also discuss how to conduct and implement risk management practices at your firm and review communication techniques to highlight the benefits of risk management.