Medical Devices

$179.00
Navigating California Prop 65 During COVID While Incorporating FSMA Preventative Controls, Best Practice Approach

 April 12 2021
 01 : 00 PM EST    
 60 Minutes
Navigating California Prop 65 During COVID While Incorporating FSMA Preventative Controls, Best Practice Approach

This session will detail the history, process, and unique CA OEHHA system for compliance and warning labeling for consumers. Additionally, we will cover all the changes since the COVID crisis hit the state and how 60 Day notices are proceeding. Also, we will cover pending cases, proposed labeling changes, and most importantly, how to navigate compliance within existing FSMA best practice preventative cont..

$179.00
Risk Management - Principles of Lean Documents and Lean Configuration

 April 13 2021
 01 : 00 PM EST    
 60 Minutes
Risk Management - Principles of Lean Documents and Lean Configuration

Risk management over arches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device. During all phases of a project, any new consideration must be held up against the scrutiny of potential risk and harm to the health of people, damage to property or to the environment during all ..

$179.00
DSHEA Compliance In 2021 And Beyond

 April 16 2021
 01 : 00 PM EST    
 90 Minutes
DSHEA Compliance In 2021 And Beyond

In 1994, Congress passed the Dietary Supplement Health & Education Act (DSHEA) which changed the health food and dietary supplement industry forever. Unfortunately, lack of enforcement and inconsistent rulings have caused countless companies headaches when deciding on new product formulations. Join us to gain a true understanding of what DSHEA is, why it was created, what compounds can be used without f..

$179.00
Sample Size Selection: Is That Number Right?

 April 21 2021
 01 : 00 PM EST    
 60 Minutes
Sample Size Selection: Is That Number Right?

Mr. Yuval Shapiro shall review the basic statistics that are behind the Sample Size selection. Explanations on how to select samples for the Design (verification and validation) phase, and for the Production phase. Also, explanations on how to use the ISO2859-1 for simple cases at production shall be provided. Selection of the correct sample size is a challenging task, especially, when regulatory authorit..

$179.00
The Role of Logbooks and Recordkeeping in Identifying Root Causes

 April 21 2021
 01 : 00 PM EST    
 60 Minutes
The Role of Logbooks and Recordkeeping in Identifying Root Causes

An out-of-compliance under GLP or ISO 17025 is a discreet and specific event. Its occurrence has major consequences for the laboratory operation. Can the incident and its timing give clues to what caused the non-compliance?The records in a lab – the logbooks for chemicals, reagent and calibration solutions, for sample preparation, for instrument maintenance and calibration, for quality checks – all are ..

$179.00
Analytical Method Validation And Transfer

 April 22 2021
 01 : 00 PM EST    
 90 Minutes
Analytical Method Validation And Transfer

This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH, and USP have each recognized the importance of th..

$179.00
FDA Regulation of Artificial Intelligence/Machine Learning

 April 22 2021
 01 : 00 PM EST    
 60 Minutes
FDA Regulation of Artificial Intelligence/Machine Learning

AI/ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance. This happens because the FDA approves the final, validated version of the software. The point of AI/ML is to learn and update the following de..

$179.00
Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017

 April 22 2021
 01 : 00 PM EST    
 90 Minutes
Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017

The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One hot topic is the focus on the “Post-Market-Surveillance-Process” and the new requirements e.g. reporting to Authorities and Notified Bodies and how this process is connected to other processes. The understanding of these changes and how to implement last-minute changes until May 2020 is essential to ke..

$179.00
Best Practices for Equipment Validation, Tracking, Calibration, and Preventive Maintenance

 April 23 2021
 03 : 00 PM EST    
 60 Minutes
Best Practices for Equipment Validation, Tracking, Calibration, and Preventive Maintenance

FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces a produc..

$149.00
Implementing Cost Effective Regulatory Compliance

 April 23 2021
 01 : 00 PM EST    
 60 Minutes
Implementing Cost Effective Regulatory Compliance

This webinar will introduce and overview the concept of containing compliance costs – working smart. The webinar will provide a comprehensive strategy for cost reduction in regulatory affairs and compliance by presenting strategies for complying with FDA regulations in a cost-effective manner. These strategies include Regulatory Documentation – Regulatory documentation is the most visible aspect of regulato..

$179.00
Aseptic Processing Overview and Validation

 April 26 2021
 01 : 00 PM EST    
 90 Minutes
Aseptic Processing Overview and Validation

This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls, and acceptable personnel behaviors. Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a high-level overview of microbiology in regards to cleanroom environmental monitoring and the associated impac..

$179.00
How to Establish, Conduct and Maintain an Effective Supplier Management Program

 April 27 2021
 01 : 00 PM EST    
 90 Minutes
How to Establish, Conduct and Maintain an Effective Supplier Management Program

The requirement for qualifying suppliers, as part of the Quality System Requirements covering the supply chain for companies, is one that presents significant challenges to the industry. The challenges include the number of suppliers to qualify, the risk to product quality that each represents, and the resources and cost to manage the program. This webinar will look at the basics of establishing a compliant..

$179.00
Design Control, Verification and Validation

 April 28 2021
 01 : 00 PM EST    
 90 Minutes
Design Control, Verification and Validation

This workshop will explore the relationship between design inputs and the verification and validation of those inputs in design control. Design control is the process under the Quality System Regulations in the Code of Federal Regulations under which medical devices are developed. The strategy and methodology of verifying and validating design inputs, including verification of product requirements..

$179.00
Effective Batch Record Review

 May 05 2021
 01 : 00 PM EST    
 60 Minutes
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..

$179.00
Vaccine Patents in the Current COVID19 Pandemic Climate

 May 05 2021
 01 : 00 PM EST    
 90 Minutes
Vaccine Patents in the Current COVID19 Pandemic Climate

The current pandemic has turned the global focus on the issues surrounding the patenting and protection of COVID-19 vaccines, drugs, and other treatments. On the one hand, companies and institutions developing these treatments want to protect their innovations. Like other patent claims, compound, composition, and method claims for vaccines must have a novel, non-obvious, and useful properties. They may also..

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