All FDA Regulated Industry

$200.00
Good Documentation Practices (GDPs) to Support FDA-Regulated Computer System Validation (CSV)

 Recorded Webinar
 90 Minutes
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Good Documentation Practices (GDPs) to Support FDA-Regulated Computer System Validation (CSV)

The webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In addition, you’ll learn about the various computer system validation deliverables and how to document them.Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems..

$200.00
Horizon Planning on Emerging Issues on Prop 65

 Recorded Webinar
 60 Minutes
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Horizon Planning on Emerging Issues on Prop 65

The Food Industry has also been subject to Prop 65 legal battles on a host of products from French fries, chocolate, coffee, bakery products, candy and baby food that may now require warning labels or other actions to mitigate safety concerns for the public. This course will provide an overview of how to navigate Prop 65 with a Preventative Control Program approach. Highlights will include Preventative Cont..

$200.00
How Successfully Apply for a Breakthrough Therapy Designation

 Recorded Webinar
 60 Minutes
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How Successfully Apply for a Breakthrough Therapy Designation

The Breakthrough Therapy Designation (BTD) is perhaps one of the most impactful incentives from the FDA as it helps get the product to market much faster than any other expedited approval pathway. Once a drug is successful in getting the BTD, the non-clinical and clinical requirements for market approval are significantly reduced. The applicants can request special meetings with FDA to discuss the developme..

$200.00
How to Conduct a Human Factors/Usability Validation

 Recorded Webinar
 60 Minutes
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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..

$200.00
How to Make Design Part of Your Product Development DNA

 Recorded Webinar
 60 Minutes
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How to Make Design Part of Your Product Development DNA

Getting your development team to move forward in a cohesive fashion can be hard. Engineers and designers can have different goals and methods during a development project. In this session, we will explore ways to embark on design research work that will fuel the product development work down the road, and learn a few things about creativity and our brains. The methods discussed will enable participants to d..

$200.00
How to prepare a standard operating procedure (SOP)

 Recorded Webinar
 60 Minutes
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How to prepare a standard operating procedure (SOP)

Standard Operating Procedures (SOPs) are required for companies that are regulated. However, there is no guidance available by regulatory bodies on how to write, maintain, and update SOPs. Often, SOPs are prepared in a way that makes compliance difficult, leading to errors or delays that will be discovered during an audit. Technically, all FDA inspections include an SOP review and it is very important to ha..

$200.00
How to Prepare for and Conduct a Regulatory Audit

 Recorded Webinar
 60 Minutes
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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..

$200.00
How to Prepare for and Host a FDA Inspection and Respond to 483’s

 Recorded Webinar
 60 Minutes
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How to Prepare for and Host a FDA Inspection and Respond to 483’s

In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection ( front room, back room), the value of mock audits, how personnel should conduct themselves, the inspection process and how to respond to 483s and warning letters. How to respond and when is critically impo..

$200.00
How to Write Error Proof Procedures

 Recorded Webinar
 90 Minutes
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How to Write Error Proof Procedures

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. Human errors start at the design stage. Procedures play a vital role in human reliability. Nevertheless, it is essential to understand human behavior and the psychology of error as well as underst..

$200.00
How to Write SOP’s for Human Error Reduction

 Recorded Webinar
 90 Minutes
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How to Write SOP’s for Human Error Reduction

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. Human errors start at the design stage. Procedures play a vital role in human reliability. Nevertheless, it is essential to understand human behavior and the psychology of error as well as underst..

$200.00
Human Error Reduction in GMP & Manufacturing Floor

 Recorded Webinar
 90 Minutes
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Human Error Reduction in GMP & Manufacturing Floor

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. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrenc..

$200.00
Human Error Reduction Techniques For Floor Supervisors

 Recorded Webinar
 90 Minutes
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Human Error Reduction Techniques For Floor Supervisors

Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allow it. To work with these challenges, it is essential to understand human behavior and the psychology of error as well as understand exactly where the ..

$200.00
Human Error Solutions: How we Reduced 60% of Human Errors in Less than a Year, a Case Study

 Recorded Webinar
 90 Minutes
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Human Error Solutions: How we Reduced 60% of Human Errors in Less than a Year, a Case Study

Pharmaceutical manufacturing sites continuously compete, even within the same company to maintain production volumes and avoid closures. To attain a status of a high performing organization manufacturing sites are implementing strategies and practices like operational excellence and performance reliability. To achieve this goal, innovative approaches to traditional processes need to take place. This webinar..

$200.00
Human Factors and Ergonomics in New Product Development: Methods and Technique

 Recorded Webinar
 60 Minutes
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Human Factors and Ergonomics in New Product Development: Methods and Technique

Human factors engineering is extremely integral to user/market adoption. Getting a product to market is difficult whether you are a struggling startup or an established original equipment manufacturer (OEM). Understanding some of the tools available on the front end of product development can help you avoid downstream problems before they become time and money wasters. Human factors engineering is one such ..

$200.00
Human Factors/ Usability following ISO 62366 and new FDA Guidance

 Recorded Webinar
 60 Minutes
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Human Factors/ Usability following ISO 62366 and new FDA Guidance

Human Factors/Usability is an analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating results with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to t..

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