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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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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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Submitting FDA Electronic Regulatory Filings - Drug Establishment Registrations and Drug Listings
Camille Davis Thornton
60 Min
Product Id: 703234
This webinar on FDA electronic filings will discuss and provide clarification on the process of submitting drug establishment registration and drug listing information to the FDA using its Electronic Submission Gateway (ESG).
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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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Budgeting for Clinical Trials: Costs of a Study and Which Costs Sponsors are Responsible to Cover
Jennifer Holcomb
60 Min
Product Id: 702332
This 60-minute webinar will help you understand what the true costs are for completing a clinical study and the unanticipated costs that may arise. You will learn about costs that a sponsor must include in a budget and costs that a site bears in the conduct of clinical research.
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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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Clinical Trial auditing - Identifying risks and building a more compliant and successful trial
Calin Popa
90 Min
Product Id: 701860
Learn how to successfully pass a clinical trial audit, how to prepare for it, where and how to identify the non compliance. Know FDA inspection strategy to identify areas of common deficiency.
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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).
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4-hr Virtual Seminar: The Quality Manual Ensuring Regulatory Requirements
Howard Cooper
4 hrs
Product Id: 704915
This 4-hr webinar will focus on product lifecycle concepts that are applicable to all of the FDA regulated industries. Learn the objectives, purpose and scope of the quality manual and how to can be adapted to each different business environment.
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The FDA Compliance Enforcement Process
David L Chesney
90 Min
Product Id: 704913
This 90 mins webinar will provide a thorough understanding of the range of FDA enforcement options and the criteria the agency applies in deciding which to use.
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eLabeling for Medical Devices: Valuable but not easy
Daphne Walmer
90 Min
Product Id: 704912
This webinar will explore the benefits of internet-based manuals/IFUs (instructions for use), as well as the products that are eligible to replace paper manuals with internet-based manuals, along with the compliance and business requirements for implementing eLabeling.
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Integrating ISO 14971 Risk Analysis into the Product Development Process
Russell Pizzuto
90 Min
Product Id: 704926
This Webinar will present the best practices for integrating medical device risk analysis into a quality system. This integrated processes spans new product development, design change, production, and post market surveillance for the lifecycle of the device. Objective evidence produced by the integrated processes can be used to demonstrate risk analysis compliance to 21 CFR 820 and ISO 14971 during an audit.