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FDAs Medical Device Clinical Trials Program
FDAs Medical Device Clinical Trials Program

$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 ...

Excel Workbooks and FDA Device Regulations
Excel Workbooks and FDA Device Regulations

$150.00

Overview: FDA regulations cover both the use of workbooks and the creation of electronic records device manufacturers must understand these regulations ...

Risk Management Techniques for Medical Devices
Risk Management Techniques for Medical Devices

$150.00

Overview: This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement the...

Medical Device Hazard Analysis Following ISO 14971
Medical Device Hazard Analysis Following ISO 14971

$150.00

Overview: The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 a...

Laboratory-Developed Tests
Laboratory-Developed Tests

$150.00

Overview: This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the h...

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...

Addressing CAPA within a Device Quality System
Addressing CAPA within a Device Quality System

$150.00

Overview: You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA this webinar...

How to Prepare for and Host a FDA Inspection and Respond to 483s
How to Prepare for and Host a FDA Inspection and Respond to 483s

$150.00

Overview: In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspe...

Building a Validation Program From Top to Bottom
Building a Validation Program From Top to Bottom

$150.00

Overview: Many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regul...

Achieving Compliance Excellence
Achieving Compliance Excellence

$150.00

Overview: We will discuss each of those keys in detail to enhance understanding and to provide the needed information to replicate the approach in your organiz...

Establish and Maintain an Effective Supplier Qualification Program
Establish and Maintain an Effective Supplier Qualification Program

$150.00

Overview: FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct. FDA will deal with your company in case of produ...

Cyber Attacks, Incident Response Checklist, Testing & Resources - Beyond Disaster Recovery
Cyber Attacks, Incident Response Checklist, Testing & Resources - Beyond Disaster Recovery

$150.00

Overview: Cyber-attacks and breaches dominate the media and are a significant focus of the government. Businesses and financial institutions are faced with the...

Webinar Calendar of Upcoming Courses - Jun 2017
Webinar Calendar of Upcoming Courses - Jun 2017

$150.00

Compliance4All webinars are just what professionals in the regulatory compliance areas need for scaling up in their careers. With a collection of the most erudi...

Medical Device Engineering Change Control
Medical Device Engineering Change Control

$150.00

Overview: This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change proc...

Bullet Proof 510(k) - Latest FDA Changes to the Process
Bullet Proof 510(k) - Latest FDA Changes to the Process

$150.00

Overview: The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process. Obj...

Understanding Aseptic Technique and Cleanroom Behavior
Understanding Aseptic Technique and Cleanroom Behavior

$150.00

Overview: Compounding sterile products are made utilizing aseptic technique. Aseptic technique is a microbiological term referring to the prevention of ...

Validation Master Planning and Regulatory Expectations
Validation Master Planning and Regulatory Expectations

$150.00

Overview: This presentation will cover the importance of master planning. The FDA and other regulatory bodies expect these to be among the Quality System...

Laboratory Accreditation Getting There is Just the Beginning
Laboratory Accreditation Getting There is Just the Beginning

$150.00

Overview: Accreditation is not a guarantee of analytical competency. Getting accredited is just the beginning. The journey begins with defining the labor...

Process Validation - Statistical Process Control
Process Validation - Statistical Process Control

$150.00

Overview: Process knowledge and understanding is the basis for establishing an approach to process control and related instruction sets in the Batch Reco...

Personnel Training to Assure FDA and ISO Compliance
Personnel Training to Assure FDA and ISO Compliance

$150.00

Overview: To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job...

Implementing Agile in an FDA-Regulated Environment
Implementing Agile in an FDA-Regulated Environment

$150.00

Overview: The Agile approach is well established in other industries adoption of Agile in medical device development has been increasing in the past five...

Successful Supplier Audits
Successful Supplier Audits

$150.00

Overview: One of the tools at your disposal to verify the supplier's acceptability is to audit its operation. This webinar is designed to provide the parti...

Dealing with Cyber Issues in Your Business Continuity Planning
Dealing with Cyber Issues in Your Business Continuity Planning

$150.00

Overview: This webinar training will discuss how to create, test and implement an effective cyber Incident program to counter cyber threat and malware ...

ACH Fraud - Detection and Prevention
ACH Fraud - Detection and Prevention

$150.00

Overview: The types of internal processes and controls necessary vary by industry and organization size. This course reviews a wide variety of options an...

Combination Products Registration
Combination Products Registration

$150.00

Overview: During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products...

Master Excel Building Resilient and Effective Budget Spreadsheets
Master Excel Building Resilient and Effective Budget Spreadsheets

$150.00

Overview: David shares a wide range of helpful techniques, including how to separate inputs from calculations, streamline formula writing, preserve key for...

USFDA Food Import and Export Current and Future Safety Regulations
USFDA Food Import and Export Current and Future Safety Regulations

$150.00

Overview: Importers of food products intended for introduction and consumption in the United States through international commerce are responsible for ...

Statistical Concepts of Process Validation
Statistical Concepts of Process Validation

$150.00

Overview: Process validation is an important element in medical device manufacturing. This presentation looks at the underlying statistical concepts to per...

Automating Excel - Macros and VBA Fundamentals
Automating Excel - Macros and VBA Fundamentals

$150.00

Overview: VBA is the programming language that is built in to Excel (and the other applications in the MS Office Suite).VBA is used to automate tasks that woul...

The overlap between engineering and psychology
The overlap between engineering and psychology

$150.00

Overview: This course will show how psychological factors enter into the engineering profession. Many aspects of the engineering profession are nontechnical su...

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