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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).
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Compliance with the New EU Clinical Trial Regulation
Laura Brown
60 Min
Product Id: 705007
This webinar will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU.
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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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Effective Deviation Investigators Under GMP
David L Chesney
120 Min
Product Id: 704974
This 120 minute training course will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.
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Project Management Essentials: The 8 Keys to Successfully Completing Every Project On-Time and On Budget
Christopher R DeVany
90 Min
Product Id: 705013
This training program will help attendees grasp the essentials of project management and plan effectively for identifying project needs. It will also discuss practices for keeping content, process, and structure on track to produce positive outcomes.
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Compliance with the New ICH GCP revised 2 Guidelines
Laura Brown
60 Min
Product Id: 704989
This New ICH GCP E6 Revision 2 changes will cover those new requirements for running clinical trials, evaluate the changes and discuss how to implement these for sponsors, CROs and study sites. This session will enable you to meet the new international GCP standard to ensure the acceptance of clinical trial data by the regulatory authorities internationally including the European Union (EU), Japan, the United States, Canada and Switzerland.
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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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Equipment Qualification Basics
Joy McElroy
90 Min
Product Id: 704403
This training program will list the documents required for equipment qualification and process validation and discuss how to manage documents appropriately. Attendees will gain insight into best practices for writing and maintaining a Validation Master Plan (VMP). The course will also discuss best practices for writing and executing sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.