Listings tagged with 'FDA regulations' (20)

FDA Regulations for Environmental Monitoring(EM) Program
FDA Regulations for Environmental Monitoring(EM) Program

$150.00

Overview: Upon completion of this training, you will be able to Describe how Clean room Environmental Monitoring Program fits into the Regulations. Explain t...

Phase I GMPs
Phase I GMPs

$150.00

Overview: Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lo...

Supplier Evaluation and Assessment How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner
Supplier Evaluation and Assessment How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner

$150.00

Overview: A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA does not directly regu...

FDA Regulations for Analytical Instrument Qualification and Validation Processes
FDA Regulations for Analytical Instrument Qualification and Validation Processes

$150.00

Overview: In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sou...

Pharmaceutical and Biologics Facility Design FDA and Regulatory Aspects
Pharmaceutical and Biologics Facility Design FDA and Regulatory Aspects

$150.00

Overview: This course explores some of the best practices of pharmaceutical facility design with an emphasis on regulatory aspects. FDA and other global regu...

3 Applying U.S. FDA Laws and Regulations 2017
3 Applying U.S. FDA Laws and Regulations 2017

$1,295.00

Course "Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC)" has been pre-approved by RAPS as eligible for up to 12 credits ...

Compliance trainings logo
Compliance trainings logo

$229.00

Description : Organizations governed by FDA must adhere to strict requirements relative to data being captured, analyzed, reported or stored on computer syste...

Compliance trainings logo
Compliance trainings logo

$229.00

Description : You should attend this seminar if you are responsible for planning, executing or managing the validation of laboratory computer systems governed...

3a73bea
3a73bea

$155.00

Overview: The FDA's Design History Files, Device Master Records, Device History Record, and the EU's MDD TF/DD -- Documentation to meet their different purpo...

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3a73bea

$155.00

Overview: Cleaning validation guidelines are an essential step in the medical device development. One of the most common methods is using extraction techniqu...

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3a73bea

$155.00

Overview: There is an on-going major shift in the emphasis of Federal Drug Administration cGMP audits. These changes in focus have a major impact on indiv...

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3a73bea

$155.00

Overview: FDA Medical Device Recalls are an effective method of removing or correcting consumer devices that are in violation of laws administered by the Foo...

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3a73bea

$155.00

Overview: "The Controls for Outsourcing Manufacturing and Testing" explores the use of outsourcing and how it impacts quality and compliance and the organiza...

Final
Final

$155.00

Speaker: David R Dills Overview Any Medical Device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or app...

Final
Final

$155.00

Overview Cleanliness is a hot topic in the medical device industry. The FDA expects medical device companies to validate the cleanliness of their devices. On...

Compliance Global Inc.
Compliance Global Inc.

$155.00

Overview: The first step in reduced testing is to qualify the supplier using the supplier qualification process. This webinar will review the supplier qualif...

3a73bea
3a73bea

$155.00

Overview: The purpose of this webinar is to provide the topics and basic instructions needed to establish the quality training systems and related practices ...

3a73bea
3a73bea

$155.00

Overview: Cleaning validation guidelines are an essential step in the medical device development. One of the most common methods is using extraction techniqu...

3a73bea
3a73bea

$155.00

Overview: The opportunity to design a total quality management from scratch offers great rewards in experiencing and understanding the functions of quality s...

3a73bea
3a73bea

$155.00

Overview: Cleanliness is a hot topic in the medical device industry. The FDA expects medical device companies to validate the cleanliness of their devices. O...

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