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All FDA Regulated Industry

All FDA Regulated Industry
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Qualification of Suppliers and Contract Manufacturing Organizations
Qualification of Suppliers and Contract Manufacturing Organizations

Suppliers and CMO’s must be selected following a rigorous formalized procedure.This webinar will des.....

$200.00
21 CFR Part 11 (Electronic Records/ Signatures) Compliance for Computer Systems Regulated by FDA
21 CFR Part 11 (Electronic Records/ Signatures) Compliance for Computer Systems Regulated by FDA

This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on .....

$200.00
21 CFR Part11 Compliance
21 CFR Part11 Compliance

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and.....

$200.00
Automating Assays for Clinical Diagnostics
Automating Assays for Clinical Diagnostics

Laboratories need to transition technologies all of the time. From new ways to perform assays, to ou.....

$200.00
CAPA: Corrective and Preventative Actions and Addressing Non-Conformances
CAPA: Corrective and Preventative Actions and Addressing Non-Conformances

CAPA is both a precursor to and component of RCA that helps people prevent non-conformances from occ.....

$200.00
Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA
Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA

FDA guidelines are very specific in terms of how computer systems are to be managed, and each compan.....

$200.00
FDA Compliance and Mobile Applications
FDA Compliance and Mobile Applications

We will discuss in detail how computer system validation can be applied to mobile applications subje.....

$200.00
Functional System Requirements Planning for Computer Systems Regulated by FDA
Functional System Requirements Planning for Computer Systems Regulated by FDA

This course is intended to provide specific guidelines for coaching attendees on the best practices .....

$200.00
Generation of Controlled Documents and Related Training
Generation of Controlled Documents and Related Training

This presentation is intended to provide the needed documentation practices associated with document.....

$200.00
How Successfully Apply for a Breakthrough Therapy Designation
How Successfully Apply for a Breakthrough Therapy Designation

The Breakthrough Therapy Designation (BTD) is perhaps one of the most impactful incentives from the .....

$200.00
Human Factors Validation Testing Following ISO 62366 and new FDA Guidance
Human Factors Validation Testing Following ISO 62366 and new FDA Guidance

Following the implementation of the results of a Human Factors/ Usability study, a validation of the.....

$200.00
In Depth Testing of Computer Systems Regulated by FDA
In Depth Testing of Computer Systems Regulated by FDA

We will discuss the importance of applying industry best practices when performing the validation pr.....

$200.00
Legal, Regulatory and Policy Issues Related to Validation of Computer Systems Regulated by FDA
Legal, Regulatory and Policy Issues Related to Validation of Computer Systems Regulated by FDA

We will discuss the importance of applying industry best practices when performing the validation pr.....

$200.00
Mathematics of Terminal Sterilization - Probability of Survival Approach -vs- Overkill Approach
Mathematics of Terminal Sterilization - Probability of Survival Approach -vs- Overkill Approach

Heat sterilization is a PROBABILITY function dependent on heat exposure, the number of microorganism.....

$200.00
Medical Device - Engineering change control
Medical Device - Engineering change control

Companies need to be able to adapt quickly in today’s constantly changing environment, and often tha.....

$200.00
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