All FDA Regulated Industry

$200.00
GMP’s Applied to Medical Cannabis: All You Need to Know

 Recorded Webinar
 90 Minutes
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GMP’s Applied to Medical Cannabis: All You Need to Know

When we discuss growing, producing, and manufacturing medical cannabis, we must think of it as a medicine. Medicine by definition is a substance intended to assist you with a medical condition, to help you feel better and not harm you. Drugs produced in the pharmaceutical industry go through extensive quality controls to ensure a level of safety for the consumer or patient. Yet when we talk process and qual..

$200.00
Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

 Recorded Webinar
 60 Minutes
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Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

Good Documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified. This 60-min Webinar covers the essentials of GDP, its definition, purpose, and importance. Then expands on general ru..

$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 Use Foreign Trade Zones and Bonded Warehouses in the U.S.

 Recorded Webinar
 60 minutes
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How to Use Foreign Trade Zones and Bonded Warehouses in the U.S.

The use of Foreign Trade Zones and Bonded warehouses for FDA regulated products create different opportunities and different obligations. Firms need to understand the requirements of each to use them to their advantage. The imported products will have different regulatory requirements depending on the option chosen. In some cases, the FDA does not give you an option and the outcome is expensive. Firms also ..

$200.00
How to Write and Manage a Change Control System

 Recorded Webinar
 60 Minutes
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How to Write and Manage a Change Control System

This webinar 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.This course will provide attendees with the proper tools and information to build a robust change contr..

$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..

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