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  • Member Since: June 2, 2016

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FDA Regulation of Combination Products
FDA Regulation of Combination Products

$150.00

Overview: A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological pro...

Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC
Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

$150.00

Overview: The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknes...

The Investigational Medicinal Product Dossier EU CTA vs. FDA IND Comparing the Content and Agency Expectations
The Investigational Medicinal Product Dossier EU CTA vs. FDA IND Comparing the Content and Agency Expectations

$150.00

Overview: This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Produ...

Recalls, Removals, and Market Corrections in Compliance with FDA and ISO Requirements
Recalls, Removals, and Market Corrections in Compliance with FDA and ISO Requirements

$150.00

Overview: To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There are certain circums...

The New FDA-Product Approval, Inspection, and Enforcement
The New FDA-Product Approval, Inspection, and Enforcement

$150.00

Overview: The US Food and Drug Administration has recently released information about its new strategies as a result of the new administration. The new comm...

Understanding Autism Spectrum Disorder
Understanding Autism Spectrum Disorder

$150.00

Overview: This is an interactive overview of how DMAIC can be utilized in a home environment to improve the quality of life for a child diagnosed as being on t...

Process Capability Analysis Of Extremely Non-normal Data
Process Capability Analysis Of Extremely Non-normal Data

$150.00

Overview: Reliability Plotting is a graphical technique that is a standard method described in some reliability textbooks. The method is used primarily for dat...

Navigating the New European Clinical Trial Regulation (EUCT Regulation 536-2014)
Navigating the New European Clinical Trial Regulation (EUCT Regulation 536-2014)

$150.00

Overview: This course covers the newly proposed requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regula...

Corrective and Preventive Action
Corrective and Preventive Action

$150.00

Overview: Medical Device managers, engineers, QA personnel, as well as lean program leaders. Do you find yourself constantly struggling to create, manage, and ...

Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

$150.00

Overview: Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regul...

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$150.00

Overview: As industry is aware of, now you must deal with the new requirements for Clinical Evaluation Reports (CER's) if you sell all classes of medical dev...

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$150.00

Overview: This webinar is designed to help you understand how the new rules for the sanitary transportation of human and animal foods will impact your logist...

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c4all logo

$150.00

Overview: Drug master files serve as documentation on the quality of an active ingredient or excipient and are submitted by a manufacturer as part of the lic...

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c4all logo

$150.00

Overview: The U.S. FDA has stated that the use of a medical device or pharmaceuticals entails some degree of risk. In fact, any medical procedure / interv...

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c4all logo

$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...

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c4all logo

$150.00

Overview: ISO 9001:2015 requires "actions to address risks and opportunities" with regard to "context of the organization" and "needs and expectations of int...

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c4all logo

$150.00

Overview: An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effective...

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c4all logo

$150.00

Overview: Financial institutions have long been the payments engines for their customers. However, with heightened competition and the advent of new non-bank...

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$150.00

Overview: The role of Quality leaders, general managers, and executives includes "Management Responsibility". It includes: Quality Policy Organization M...

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c4all logo

$150.00

Overview: Effective sanitation in the food industry involves the maintenance of clean conditions in the entire food operation including the control of pests ...

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c4all logo

$150.00

Overview: We will introduce you to an effective and affordable methodology that identifies prospective targets which are related to, or controlled by tectoni...

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c4all logo

$150.00

Overview: This 60 minute webinar will cover traceability requirements and techniques useful in the event of quality deviation investigations and potential FD...

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c4all logo

$150.00

Overview: This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recal...

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c4all logo

$150.00

Overview: The course takes one through the rigors of RCA as it applies to CAPA. There are ways of making the journey easier and structuring it so that the ri...

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c4all logo

$150.00

Overview: The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA. This webinar will address the use of the FD...

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c4all logo

$150.00

Overview: The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) ...

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c4all logo

$150.00

Overview: The best way forward is an efficient Incident Response Program that allows an organization to respond with speed and agility, while empowering busi...

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c4all logo

$150.00

Overview: Lean principles for Continuity Planning, when practiced every day in a consistent manner, align business systems and processes with the needs and g...

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c4all logo

$150.00

Overview: This web seminar builds on the terminology found in 21CFR160(b)(4) and introduces terminology and concepts not found in the regulation , but necess...

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c4all logo

$150.00

Overview: The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the prod...

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