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How to Prepare for, Manage, and Follow-up to an FDA Inspection
Jeff Kasoff
60 Min
Product Id: 701236
This FDA inspection training will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.
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Preparing for Regulatory Audits
Nick Campbell
60 Min
Product Id: 701170
In this FDA audit & Inspection training we will focus on ideas that will help identify areas of improvement before the formal inspection occurs. Further, you will learn techniques that will enhance your effectiveness during the audit execution.
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How to perform effective supplier audits, and avoid FDA 483
Dennis Moore
60 Min
Product Id: 701193
This FDA audit & inspection training will provide your firm with key insights on how to perform superior supplier audits. It will help you uncover purchasing controls GMP violations.
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cGMP 'Pitfalls' in the QC Laboratory-Preparing the QC Laboratory and Staff for an FDA Inspection
Michelle Sceppa
60 Min
Product Id: 701187
The FDA Audit inspection training defines the laboratory environment; points out problem areas and common pitfalls; and details solutions and also details how to prepare the Laboratory staff for an Inspection as well.
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Surprise FDA GMP inspection - how to prepare for it
Peter Calcott
90 Min
Product Id: 701203
This FDA GMP (Good Manufacturing Practice) inspection training will walk you through the elements you should plan for, the timing and the logistics of who should do the various components in preparation for the inspection.
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Auditing Failure or Process Deviation Investigations
Michelle Sceppa
42 Min
Product Id: 701128
This FDA Inspection training will examines the audit process and how to manage Process Deviation Investigations.
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GxP Computer Systems Validation: The Investigator's Point of View
Dale Hunscher
60 Min
Product Id: 701069
In this presentation, we will look at these documents from the investigator’s point of view, reviewing the FDA training manual and actual FDA warning letters and responses. This will reveal what the investigator is trained to look for and what types of problems are actually being discovered in the field offices.
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FDA at the Door: Ten Essential Steps for Inspection Success
Anne E Maczulak
60 Min
Product Id: 701090
This FDA inspection training compiles the best practices now being used by many companies to host FDA inspections that will satisfy FDA inspectors and result in a good experience for the company. FDA inspections require a large amount of preparation and knowledge. Are you informed enough to avoid Warning Letters
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The Secret of Study Conduct Documentation to ensure a successful Audit: What the FDA Inspectors looks for
Charles H Pierce
90 Min
Product Id: 701075
This FDA audit training will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Data keeping for clinical research trials involving human subjects has to be as accurate and valid as possible. Does yours meet the mark?
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NEW Guidance for Industry: CGMP for Phase I Investigational Drugs
Jamie Jamshidi
90 Min
Product Id: 701064
This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a) (2) (B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND).
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PASSING A US FDA GMP INSPECTION: A-Z Guaranteeing a Pass the First Time through an FDA Inspection
Michael Anisfeld
90 Min
Product Id: 701026
In this FDA cGMP Inspection training learn all the background information and key Techniques needed to guarantee a cost-effective, first-time pass through an FDA inspection - whether for a pharmaceutical product, an active pharmaceutical ingredient (API), a medical Device or a biological production. The world of GMP compliance has dramatically changed with FDA stressing pre-approval inspections, risk management, investigations and CAPA, quality systems approaches, and process and analytical technology (PAT) applications. If you last passed an FDA inspection more than four years ago, or if you have never faced an FDA inspection, you will be unprepared for FDA’s 21st-century inspection methods. This course provides all the background information and key techniques needed to guarantee a cost-effective, first-time pass through an FDA inspection— whether for a pharmaceutical product, an active pharmaceutical ingredient (API), a medical device or a biological product. All API, medical device, diagnostic product manufacturer, biotechnology product or pharmaceutical manufacturers—no matter in which country they operate—must pass an on-site FDA inspection of their facilities and operations if products are to be sold in the United States.
This webinar is designed to provide background and insight into the inspection process, as well as practical strategies and tactics that a company must know and implement in order to have the potential to pass an inspection the first time through. The webinar covers everything you need to know—from the background to the inspection, including the importance of the commitments made in the product application (the DMF, the NDA, the BLA or the PMA). In addition we will discuss the differences between good science and GMP compliance issues. The inspection process itself will be analyzed and reviewed in a manner that will allow you to immediately begin effective strategizing on how to pass the inspection. Nothing has been left out. The course touches on everything, and we do mean everything, you need to know to have a smooth and successful inspection.
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A FDA Audit - What You Need to Know
Bernice Russell Bond
90 Min
Product Id: 701042
This presentation will provide you with the tools to prepare for and support the audit process executed by regulatory bodies.
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What We Can Learn From Warning Letters
Anne E Maczulak
90 Min
Product Id: 700946
In this Good Laboratory Practices training on FDA warning letter learn how to avoid making the same mistakes in your study and to avoid having your company's name publically cited for inspection findings.
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Investigations and Corrective/Preventive Actions
Nick Campbell
60 Min
Product Id: 701019
In this seminar, you will learn how to document unexpected situations accurately and completely. Are your investigations done haphazardly or in an inconsistent manner? Are your reports hard to understand? Is the discrepancy resolution process slowing your product release efforts unnecessarily?
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Preparing for FDA Pre-Approval Inspections
Peter Calcott
60 Min
Product Id: 700894
An assessment of your people to determine who should be talking with the FDA and most importantly, who should not must be performed. This webinar will provide the process map for the compliance and quality staff to build their strategy and plans for preparing for and executing their preparation work for a PAI in the Pharmaceutical and Biotechnology world.
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How to Prepare for FDA GMP Inspections
James Harris(PhD)
60 Min
Product Id: 700990
This program outlines a system for preparing for an unexpected inspection and details SOPs that should be established in advance of the appearance of an inspector at your front door. This Webinar will provide valuable assistance to all regulated companies that face unscheduled inspections by regulatory agencies.
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Investigator responsibility/Legal commitment in drug and device clinical research: the reality
Charles H Pierce
90 Min
Product Id: 700923
To follow the regulations is Good Clinical Practices (GCP) and common sense. To not know and follow these regulations is folly. This Webinar will provide invaluable assistance to investigators and staff with regulatory/ legal responsibilities. It also delves into the complex ethical considerations in pharmaceutical product (drug or device) research involving human subjects.
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How to prepare for the unannounced FDA compliance inspection
Peter Calcott
60 Min
Product Id: 700892
This webinar will walk you through the elements you should plan for, the timing and the logistics of who should do the various components in preparation for the inspection.
Why investigators often lose money in conducting sponsored clinical trials
Stephen Schwartz
60 Min
Product Id: 700880
A proven process for investigators will be presented to address common deficiencies with respect to costs associated with clinical investigator site requirements for studay conduct.
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'Performing effective supplier audits: a coming FDA compliance focus'
Dennis Moore
60 Min
Product Id: 700436
his presentation will cover auditing and management techniques in relation to purchasing control compliance. Real supplier auditing processes and other management tools associated with purchasing controls will be discussed Many firms feel that they are adequately auditing and managing suppliers, yet find they are having myriads of quality issues. FDA and other auditing organizations are going to focus on supplier auditing compliance in 2007-2008