Listings tagged with 'FDA' (45)

Computer code
Computer code

This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer ...

Woman working on machinery in assembly line
Woman working on machinery in assembly line

$185.00

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.

Man at computer in office
Man at computer in office

This course addresses how to write effective correspondence, reports, SOPs, and protocols in support of your company's activities.

New FDA or EMA and USP Guidelines for Transfer of Analytical Methods
New FDA or EMA and USP Guidelines for Transfer of Analytical Methods

$150.00

Overview: When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable resul...

FDA Scrutiny of Promotion and Advertising Practices
FDA Scrutiny of Promotion and Advertising Practices

$150.00

Overview: DTC may be deemed as misbranding your product and, therefore, may not be marketed. Firms must be more sophisticated now in designing their advertis...

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...

8 Requirements for Establishing an Effective Cleaning Validation Program 2017
8 Requirements for Establishing an Effective Cleaning Validation Program 2017

$1,295.00

Course "Requirements for Establishing an Effective Cleaning Validation Program" has been pre-approved by RAPS as eligible for up to 12 credits towards a partici...

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 ...

LSTI_410x310
LSTI_410x310

$299.00

Update to ICH GCP E6 (R2) – Changes and Implementation Date: December 12, 2016 Time: 1:00pm-2:30pm, EST US Duration: 90 Minutes - Online Price: $299 - Inc...

LSTI_410x310
LSTI_410x310

$299.00

FDA Guidance on Social Media: Questions Answered and Unanswered Date: December 1, 2016 Time: 1:00pm-2:30pm, EST US Duration: 90 Minutes - Online Price: $2...

Drues LinkedIn Photo
Drues LinkedIn Photo

$299.00

Communication With FDA: What Do We Say And How Do We Say It? Date: November 30, 2016 Time: 1:00pm-2:30pm, EST US Duration: 90 Minutes - Online Price: $299...

LSTI_50x31
LSTI_50x31

$299.00

Biosimilars: Preparing For Opportunities And Challenges (RECORDED WEBINAR) Date: October 11, 2016 Time: 1:00pm-2:30pm, EDT US Duration: 90 Minutes - Online...

LSTI_50x31
LSTI_50x31

$299.00

Understanding & Implementing The New NIH & FDA Draft Clinical Trial Protocol Template Date: RECORDED VERSION Time: 1:00pm-2:30pm, EDT US Duration: ...

Compliance trainings logo
Compliance trainings logo

$229.00

Description : The success of an audit by federal regulators does not always depend on the level of training provided to staff and department employees, but al...

Compliance trainings logo
Compliance trainings logo

$229.00

Description : Root cause analysis (RCA) involves searching backwards from an undesirable effect (or problem) to its cause(s) and addressing those causes. Whil...

Compliance trainings logo
Compliance trainings logo

$229.00

Description : The FDA’s requirements for medical device labeling range from the typical general requirements down to very specific information about an indivi...

Compliance trainings logo
Compliance trainings logo

$229.00

Description : Design Control is an integral part of any quality system in regulated industries. FDA Quality System regulation, Quality System Inspection Techn...

PRISYM-Logo-cmyk_2013
PRISYM-Logo-cmyk_2013

Label End to End Tracking. Do you have it? Labeling is an integral component within the medical device production process, with manufacturers needing to ensu...

Kierstan
Kierstan

$249.00

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

RobBraido
RobBraido

$249.00

Description : Every medical device company (OEM) must meet certain standards for validation of its transfer plans, facilities, clean rooms and processes. Thes...

$249.00

Description : The Generic Drug User Fee Amendments of 2012 (GDUFA) were designed to speed the delivery of safe and effective generic drugs to the public and r...

SusanneManz
SusanneManz

$249.00

Description : Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes leading to 483s and ev...

$249.00

Description : We will discuss the importance of applying industry best practices when validating systems and applications used in the tobacco industry, as reg...

AngelaDunston
AngelaDunston

$249.00

Description : The pharmaceutical industry is expected to make arrangements to ensure that the accuracy, completeness, content, and meaning of data are retaine...

DavidLim
DavidLim

$249.00

Description : This webinar will provide an opportunity to get familiar with an FDA's process to communicate with the industry early in the process for sustain...

CarolynTroiano
CarolynTroiano

$249.00

Description : We will discuss the importance of applying industry best practices when managing projects involving development, configuration, implementation, ...

KenChristie
KenChristie

$249.00

Description : The sterilization of products or components is achieved through a variety of methods. This webinar will cover the common methods of sterilizatio...

fsmapart10social
fsmapart10social

$179.00

The Food Institute and premier FDA/USDA law firm OFW Law are offering a 12-part webinar series on the new Food Safety Modernization Act (FSMA), the most sweepin...

$349.00

Note: This Webinar covers topics relevant to both drugs AND devices. FDA is more vigilant and aggressive than ever before with its 483 and warning letter enf...

$189.00

In December 2010 the FDA began a project to better understand the industry’s adherence (or lack thereof) to 21 CFR Part 11. This involves the ‘add on’ sur...

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