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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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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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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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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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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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Selection and Management of Contract Vendors
Peggy Berry
90 Min
Product Id: 704884
This webinar will discuss approaches to selecting vendors to perform manufacturing and testing activities as well as clinical study activities. The information obtained will enable implementation of an effective vendor selection program and a comprehensive vendor management and oversight program. The webinar will address aspects of requesting bids, performing audits, evaluating risks, and preparing plans and agreements for effective oversight and management.
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Integrating Pharmacovigilance and Technical Complaint Systems
David L Chesney
90 Min
Product Id: 704956
This webinar will discuss the FDA requirements for pharmacovigilance and complaint evaluation under GMP
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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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Executive Exposure under Strict Liability Doctrine in FDA Enforcement
David L Chesney
90 Min
Product Id: 704951
This webinar will discuss the FDA requirements for the involvement of the executive level in compliance governance. It will also discuss two major Supreme Court cases relied upon by the FDA to support their position on strict liability. Attendees will gain an understanding of the FDA policy and steps you can take to mitigate its impact.
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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.
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Providing DMFs in eCTD format
Peggy Berry
90 Min
Product Id: 704934
This webinar will review the CTD format and content requirements for the DMF. It will discuss the transition from other formats to the CTD/eCTD and technical requirements for eCTD submission.
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Implementing the New Usability Engineering Standard
Daniel O Leary
90 Min
Product Id: 704894
Usability Engineering has become a major topic. The current standard tightens the linkage to risk management. In addition, there are changes in the US and EU approach, all of which find a basis in this standard. Attending this presentation provides the information you need to prepare for these major changes.
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Validation Master Planning - The Unstated Requirements
John E Lincoln
90 Min
Product Id: 704292
This training program will focus on U.S. FDA and EU's MDD expect documented risk-based VMP planning, though the CGMPs mention little about it. The course will analyze product V&V versus process/ equipment V&V and how to use DQ, IQ, OQ, PQ, and ASTM E2500 equivalents.
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Creating Effective SOPs for Regulatory Compliance
Henry Urbach
60 Min
Product Id: 702999
This FDA documentation webinar will explain the regulatory expectations for, and the proper design and maintenance of effective and compliant standard operating procedures (SOPs).