Medical Devices

$179.00
Leverage Regulatory Documentation – Write SOPs that Actually Work and Have Value

 June 18 2021
 01 : 00 PM EST    
 60 Minutes
Leverage Regulatory Documentation – Write SOPs that Actually Work and Have Value

Compliance documentation to include Standard Operating Procedures – the documentation required by regulation – is essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purp..

$179.00
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

 June 21 2021
 01 : 00 PM EST    
 90 Minutes
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable, a test method must be reliable both in detecting defects and in not rejecting acceptable samples. Those who work with process optimization and validation focus..

$179.00
Achieving Compliance with Proper CAPA Systems

 June 23 2021
 01 : 00 PM EST    
 60 Minutes
Achieving Compliance with Proper CAPA Systems

This webinar will include discussions on proper CAPA system maintenance, root cause analysis, documentation of the Corrective and Preventative Actions, and developing a robust CAPA plan. It will give tips on how to develop CAPAs pertaining to longer-term projects and ensure they stay on track.   Learning ObjectivesDiscuss what to do when problems occurOutline the requirements of the CAPA process a..

$179.00
Using Kanban/JIT Systems and Lean Elements to Run a Startup Plant

 June 23 2021
 01 : 00 PM EST    
 90 Minutes
Using Kanban/JIT Systems and Lean Elements to Run a Startup Plant

A medical device or biotechnology startup plant needs to have products available yet be agile enough to respond quickly to demand and design changes without wasting excess inventory, especially from obsolete products that did not pan out. This webinar explains how to set up and use kanbans all the way from Purchasing and Procurement, to Receiving, Receiving Inspection, Component Stock, Work Order Picking/St..

$179.00
Training Requirements and Practices to Assure QSR and ISO Compliance

 June 25 2021
 03 : 00 PM EST    
 60 Minutes
Training Requirements and Practices to Assure QSR and ISO Compliance

A complete and effective employee training program must be in place to assure training requirements are established, implemented, and verified. This session will instruct attendees on the regulatory requirements of personnel training, and the establishment of a the training program, including new employee training, methods of training, how to document training so that it is readily available for r..

$179.00
How to Conduct a Human Factors/Usability Validation

 June 28 2021
 01 : 00 PM EST    
 60 Minutes
How to Conduct a Human Factors/Usability Validation

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria are qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 10..

$179.00
Biosafety and Blood-borne Pathogen Safety in the Lab

 July 01 2021
 01 : 00 PM EST    
 60 Minutes
Biosafety and Blood-borne Pathogen Safety in the Lab

This webinar will review how best to approach biosafety and implement an effective management program for blood-borne infections, safety and health, laboratory safety, infectious material, and blood infection. If you work in a laboratory exposed to viruses or bacteria that are biological hazards and are searching for a better way to manage your Biosafety program, this webinar will help give you the framewor..

$179.00
CDER Direct - Overview And Helpful Hints

 July 14 2021
 03 : 00 PM EST    
 60 Minutes
CDER Direct - Overview And Helpful Hints

The specifications for the electronic drug establishment registration and drug listing information required by FDA are generally defined in the Health Level 7 (HL7) Structured Product Labeling (SPL) document mark-up standard. Further, the HL7 SPL document mark-up standard provides compliance details about minimum requirements for the structure and semantics of the content of authorized published information..

$179.00
Software Validation Utilizing Principles of Lean Documents and Lean Configuration

 July 15 2021
 01 : 00 PM EST    
 90 Minutes
Software Validation Utilizing Principles of Lean Documents and Lean Configuration

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. New approaches to software validation will help avoid many of the structural costs with a major endeavor by removing legacy methods that applied to paper systems. This will also set the stage for further integratio..

$179.00
Practical CAPA

 July 16 2021
 01 : 00 PM EST    
 60 Minutes
Practical CAPA

The CAPA process is often so poorly implemented that it inevitably leads to compliance problems. Management often doesn’t properly allocate and support resources. In this talk, we’ll discuss pitfalls and a more practical approach.The CAPA process is one of the least understood and most reviled processes in the industry. This shouldn’t be the case. Historically, the CAPA process is the long-running number 1 ..

$179.00
21 CFR Part 11 (Electronic Records/Signatures) Compliance For Computer Systems Regulated By FDA

 July 19 2021
 03 : 00 PM EST    
 90 Minutes
21 CFR Part 11 (Electronic Records/Signatures) Compliance For Computer Systems Regulated By FDA

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes the development of a company philosophy and approach and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.Areas CoveredCo..

$179.00
GMP Audits: Tools and Techniques

 July 19 2021
 01 : 00 PM EST    
 60 Minutes
GMP Audits: Tools and Techniques

The extreme criticality of GMP audits and the potential consequences, many pharmaceutical manufacturers have adopted a program of internal and external GMP audits in order to find and correct areas where sites are not in full compliance with the GMP regulations before an FDA audit occurs. By providing proper tools and techniques to be used during a GMP audit. The auditor can begin to understand the areas wh..

$179.00
Developing A Strategic Approach To FDA Compliance For Computer Systems

 July 20 2021
 03 : 00 PM EST    
 90 Minutes
Developing A Strategic Approach To FDA Compliance For Computer Systems

This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is ma..

$179.00
How to Prepare for and Conduct a Regulatory Audit

 July 21 2021
 01 : 00 PM EST    
 60 Minutes
How to Prepare for and Conduct a Regulatory Audit

This session will be highly interactive with audience members actively participating in an open discussion of their audit experience. Through discussion and examples, participants will gain an understanding of how to prepare for an audit, strategies to conduct and support a successful audit, and ways to respond to audit observations. Special consideration will be given to virtual audits as a result of the C..

$179.00
How to Write Effective 483 and Warning Letter Responses

 July 21 2021
 01 : 00 PM EST    
 90 Minutes
How to Write Effective 483 and Warning Letter Responses

The outcome of regulatory inspections is critical to an organization’s success. If the outcome of the inspection results in FDA 483 observations or a warning letter, it is important to take the observations and subsequent responses very serious. This course will discuss the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters; as well as, edu..

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