Pharmaceutical

$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
The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory

 December 07 2022
 01 : 00 PM EST    
 60 Minutes
The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory

Compliance under GLP can be difficult. The setting up of a system to monitor the performance of methods and instruments can lessen this. Statistical Process Control (SPC) uses control charts and statistical guidelines to monitor a wide variety of things in the compliant laboratory. These generate a proactive system to assess problems early on and quickly to be handled by adjustments rather than the strict s..

$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..

$179.00
Computer Validation: Methodologies and Approaches for Greater Innovation and FDA Compliance

 April 19 2023
 01 : 00 PM EST    
 90 Minutes
Computer Validation: Methodologies and Approaches for Greater Innovation and FDA Compliance

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 syst..

$179.00
Computer Software Assurance (CSA) – FDA’s Draft Guidance for Validation of Regulated Computer Systems

 May 15 2023
 01 : 00 PM EST    
 90 Minutes
Computer Software Assurance (CSA) – FDA’s Draft Guidance for Validation of Regulated Computer Systems

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 syst..

$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..

$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
5S for Operators

 Recorded Webinar
 90 Minutes
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5S for Operators

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. One method to improve productivity and reduce human error is the “5S Method”. This webinar is intended to provide you with practical knowledge on how to keep your workplace cleaner, safer, simpler..

$200.00
Adverse Event Reporting Rules for Drugs, Dietary Supplements & Cosmetics

 Recorded Webinar
 60 Minutes
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Adverse Event Reporting Rules for Drugs, Dietary Supplements & Cosmetics

This event will cover everything you need to know about how to Define a Serious Adverse Event and FDA’s Serious Adverse Event (SAE) reporting requirements for OTC Drugs, Cosmetics, and Dietary Supplements. It will also cover what to expect regarding reporting changes for Cosmetics when the Personal Care Products Safety Act is passed.All OTC drugs and Dietary Supplements are required to report Serious Advers..

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