Food and Dietary Supplements

$179.00
Robust CAPA Process for Medical Devices

 December 07 2022
 01 : 00 PM EST    
 60 Minutes
Robust CAPA Process for Medical Devices

Mr. Yuval Shapiro shall present the requirements for Corrective and Preventive actions as required by medical devices standards (ISO13485, etc.) and the common practice.The difference between Correction, Corrective Action and Preventive Action will be discussed.Mr. Shapiro shall present common sources for CAPA, tools for root-cause-analysis, e.g. – 5 Why, Cause and Effect Diagram, Pareto Charts, etc.Also, w..

$179.00
Best Practices for Auditing of Vendor of Computer Systems Regulated by FDA

 December 08 2022
 01 : 00 PM EST    
 90 Minutes
Best Practices for Auditing of Vendor of Computer Systems Regulated by FDA

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health, organ donation, and tobacco. Functions that are applicable include research and development, clinical sample manufacturing, packaging, labeling and distribution, clinical testing and management, adverse events management, and post-marketing surveillance. You should..

$179.00
Environmental Monitoring Investigations

 December 08 2022
 02 : 00 PM EST    
 60 Minutes
Environmental Monitoring Investigations

This seminar will provide an overview of environmental monitoring investigations and tools to complete an investigation. Environmental monitoring is the method by which clean rooms are known to maintain a certain level of cleanliness. The methods by which clean rooms are monitored are through viable and non-viable testing. Through this testing, a room may demonstrate that it is out of control. This seminar ..

$179.00
Risk Based Design Control - The New Paradigm for Medical Device Design

 December 20 2022
 01 : 00 PM EST    
 60 Minutes
Risk Based Design Control - The New Paradigm for Medical Device Design

Design Control is essentially a quality assurance program for the Research and Development department. The VP or Director of research and development owns the design control effort. Over the years many companies have included the design control requirements into their project plans and build the Design History File as part of the development process. Nothing has changed in these basics, but FDA’s and ISO’s ..

$179.00
EU Medical Devices Regulation: The Practice

 January 25 2023
 01 : 00 PM EST    
 90 Minutes
EU Medical Devices Regulation: The Practice

The EU Medical Device Regulation (MDR 745/2017) represents a considerable change from the directives it is replacing. Device manufacturers who conduct business in the EU must start their transition now in order to meet the deadline. This training is the first peek into this uncharted realm. During this class participants will be introduced to the new requirements in the Medical Device Regulation (MDR), incl..

$179.00
Risk Management - Implementing ISO14971: 2019

 Feb 07 2023
 01 : 00 PM EST    
 60 Minutes
Risk Management - Implementing ISO14971: 2019

Mr. Shapiro shall present the basic principles and practices of Risk Management and Risk Analysis.The risk-based approach has become a key element of quality management and as a fundamental process in the design and development of medical devices product.This process has been streamlined within ISO14971 standard and has become the best practice to show application of risk-based approach implementation in th..

$200.00
Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software

 Recorded Webinar
 90 Minutes
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Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software

Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges. The approach to developing software, performing validation, and maintaining a sy..

$200.00
Effective Batch Record Review

 Recorded Webinar
 60 Minutes
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Effective Batch Record Review

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production a..

$200.00
Implementing a Change Control Quality System Successfully

 Recorded Webinar
 60 Minutes
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Implementing a Change Control Quality System Successfully

This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution, and final implementation. The importance of proper planning, critical thinking skills, and coordination of all change activities will also be discussed.Learning ObjectiveIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrate..

$179.00
The FDA Inspection: Best Practices for Preparation, Behavior, and Response

 November 15 2022
 01 : 00 PM EST    
 60 Minutes
The FDA Inspection: Best Practices for Preparation, Behavior, and Response

This session 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. Also contained in this session will be the limits of the FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.Areas CoveredTypes of InspectionsPreparation&..

$200.00
Trends in FDA Compliance and Enforcement for Regulated Systems

 Recorded Webinar
 90 Minutes
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Trends in FDA Compliance and Enforcement for Regulated Systems

FDA requires that all computer systems used to produce, manage, and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit. As a “GxP” system, following Good Manufacturing, Laboratory, and Clinical Practices, the ..

$200.00
2019 Safe Food For Canadians Regulations

 Recorded Webinar
 60 Minutes
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2019 Safe Food For Canadians Regulations

The new standards will be covered in this session encapsulating everything industry needs to know on launching the SFCR.Understanding SFCR and HistoryLicensingPreventative ControlsImportingExportingPortal Overview and ResourcesCompliance Timelines for ImplementationNew Food Safety Regulation to process, import or export foods.Learning ObjectivesBackground on SFCRGuidance ResourcesProvincial TradingForeign S..

$200.00
2019 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance

 Recorded Webinar
 90 Minutes
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2019 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by an explanation on how to get from..

$200.00
2020 Safe Food for Canadians Regulations

 Recorded Webinar
 60 Minutes
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2020 Safe Food for Canadians Regulations

Safe Food for Canadians Regulation (SFCR) kicked off January 2019 after several long gazette comment periods by the CFIA (Canadian Food Inspection Agency). This session delivers a broad overview of the standard and covers resources for compliance. Under this regulation, many food companies are now required to register for a license, with many aspects mimicking the new FDA FSMA requirements. The new portal, ..

$200.00
21 CFR Part11 Compliance

 Recorded Webinar
 60 Minutes
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21 CFR Part11 Compliance

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants t..

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