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Investigating Out of Specification Guidance (OOS) in the Laboratory
Michelle Sceppa
60 Min
Product Id: 701127
This Pharmaceutical training provides guidance to the pharmaceutical industry pertaining to the investigation process for occurrences where laboratory results fall outside of specification limits.
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Deviations and Process Failures within a CAPA program
Michelle Sceppa
40 Min
Product Id: 701096
This CAPA training presentation will review Failure Investigations and CAPAs; it will describe methods for meeting those requirements. Many regulated companies still do not have a robust Failure Investigation and/or CAPA programs. Failure investigations and Corrective and Preventive actions (CAPA) are amongst the most frequently found deviations in FDA warning letters. Companies have procedures but either they are not adequate or are not followed. This CAPA training presentation will review Failure Investigations and CAPAs; it will describe methods for meeting those requirements.
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Gage R & R - Improving the Reliability and Reducing the Variation of Your Measurement System
Vinny Sastri
60 Min
Product Id: 701084
This Webinar will provide a basic and practical understanding of the method and will include both continuous and attribute test methods. All measurements have variation. Identifying the root causes and sources of this variation and finding ways to minimize the variation will result in test methods that one can use with high confidence to test and release acceptable products to the end-user. One of the most common methods used to assess a measurement system’s capability is the Gage Repeatability and Reproducibility (Gage R&R). It focuses on identifying and reducing the variation in the measurement system.
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Principal Investigator responsibility in Research Involving Human Subjects: The International Conference on Harmonization (ICH) view
Charles H Pierce
90 Min
Product Id: 701077
This webinar 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.
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Integrating Risk Management with the Quality System
Edwin L Bills
90 Min
Product Id: 701039
The purpose is to assure that the medical product is designed, manufactured, and distributed in such a manner that the customer receives the safest possible product. This webinar will provide guidance to those responsible for implementation of risk management processes in medical product companies.
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How to conduct a Clinical Trial in accordance with FDA regulations and how to avoid the common deficiencies observed during FDA clinical audits
Elizabeth Bergan
90 Min
Product Id: 701054
This Clinical Trial training will provide a detailed review of the FDA regulations for Clinical Trials Process. This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. After attending this session, participants will have an understanding of FDA regulations pertaining to the implementation of clinical trials and concepts of Good Clinical Practice (GCP) and Bioethics.
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510(k) Applications made Simple
E.J Smith
60 Min
Product Id: 701082
This 510(k) Training covers the content requirements of a traditional 510(k) application and covers in detail the recommended 20 sections. This 510(k) Training deals only with those medical devices that require a 510(k) application. All Manufacturers introducing Class II medical devices to the US market must submit a FDA 510(k). It is also required for manufacturers that are changing the intended use of the medical device, or changing the technology of a cleared device such a way that it may significantly affect its safety or effectiveness.
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Clinical Trials Process: Study Sponsor's and Investigator's Responsibilities
Elizabeth Bergan
Product Id: 701095
FDA Regulations and Good Clinical Practice Guidelines will be discussed with an emphasis on data integrity and the protection of study subject’s welfare/rights. This course will provide an overview of the Clinical Trial Process. It will discuss in detail the responsibilities of the Sponsor (company or institution managing the trial) and Investigators conducting a clinical trial.
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Changes to the Medical Devices Directive: 93/42/EEC
David Dills
60 Min
Product Id: 701073
This webinar will provide valuable assistance and guidance to medical device companies that are preparing for CE Mark and ensuring compliance to MDD 93/42/EEC.
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Best Practices in GLP Final Reporting and Study Closure
Anne E Maczulak
60 Min
Product Id: 701091
This GLP (Good Laboratory Practices) webinar reviews the process of closing a study by preparing a final report and managing all records and specimens in a proper manner. The GLP final study report represents the last chance for a study team to present their results in a clear and compelling manner. The report may also be a place where difficulties can be explained so that the study provides meaningful and trustworthy information. This webinar reviews the process of closing a study by preparing a final report and managing all records and specimens in a proper manner. It provides two areas of concentration: (1) the best practices in final report writing and (2) the step-by-step process of closing studies.
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The IDE (Investigational Device Exemption) - It's Purpose and Preparation
John E Lincoln
60 Min
Product Id: 701087
This IDE (Investigational Device Exemption) webinar will cover its purpose and preparation recommended subject headings and content Submission and follow up Usage in the clinical trial(s).
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Test Method Validation Basics - Ensuring Adequacy and Reliability of Your Test Methods
Vinny Sastri
60 Min
Product Id: 701083
This webinar describes the importance of and the key elements in a test method validation, including an understanding of its adequacy, range of detection, accuracy, the precision of measurements, and ultimately its robustness and reliability.
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Internal Control: Concepts & Application
Bernice Russell Bond
Product Id: 701046
This workshop will provide you with the knowledge necessary to apply the COSO model in order to manage your business risk. Today when we talk about internal control, we’re talking about a new standard. Promulgated by the Committee of Sponsoring Organizations (COSO), also known as the Treadway Commission, which has caused a paradigm shift where the emphasis is on identification and management of business risks.This workshop will provide you with the knowledge necessary to apply the COSO model in order to manage your business risk.
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The Food And Drug Amendments Act of 2007-Does IT Affect You?
Sandra N. Whetstone
60 Min
Product Id: 701041
This presentation will give an overview of the FDAAA and summarize the new provisions pertaining to specialized pediatric medical device development, food safety, advisory committee provisions, clinical trial registries and drug safety enhancement.
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Basics of Writing Validation Protocols for Medical Devices
Lawrence Spritzer
Product Id: 701099
This Medical Device training will describe the information needed to write such protocols, and the basic contents of those protocols. This webinar will provide valuable assistance to all regulated companies that need to validate their manufacturing processes.
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Basic USDA and FDA Food Labeling: Learn to Create Labels in Compliance with Regulations and Understand the Essential Elements of Labels
Cathy Crawford
60 Min
Product Id: 701094
This Food Safety Training will assist employees of the food industry in knowing how to legally prepare labels for both FDA and USDA interstate commerce food products. Food labels can be complex for those who prepare and apply them as well as those who simply want to understand the products they are purchasing. Those who create and apply labels must understand the regulations to avoid the potential negative consequences of labeling errors. An inaccurate label can lead to customer or consumer complaints, product recalls, FDA or USDA enforcement actions, fines, and even harm to consumers’ health. Companies need to know how to legally label their products and the accuracy that is required. Those who purchase products should also know what information on the label is mandatory and where to find that information. They should be aware of the level of accuracy required, or not required, regarding the data presented on labels. Does an expiration date mean the product should be thrown out after that date? When comparing items for purchase, is the one with 150 calories better for you than the one with 160? Those responsible for purchasing products to serve in restaurants, hospitals, day cares or schools should know what they are buying based on the data on the label. Understanding the labeling rules will help with purchasing decisions.
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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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GMP Expectations for Products Used in Early Phase IND Studies
Steven S Kuwahara
75 Min
Product Id: 701009
This presentation will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. This presentation will be aimed at helping Regulatory, Quality Assurance and Quality Control personnel to understand the varying levels of quality activities that accompany early stages of Product development.
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Documenting & Conducting CAPA Investigations
Nathan Conover
60 Min
Product Id: 701038
This CAPA training provides a process to overcome challenges for Documentation and Conducting CAPA Investigations and integrates FDA requirements and guidelines. "Failure to employ effective CAPA systems can lead to FDA Warning Letters and worse. Accurate documentation is a must – but capturing information from a diverse workforce can be very difficult. Do you have what it takes to meet these challenges?".
Fact: The FDA has noted that 76% of all Warning Letters have CAPA-related issues. This is a significantly large percentage – the results of companies doing a bad job of identifying corrective and preventive actions as well as not validating plan effectiveness.