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  • Member Since: June 2, 2016

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Project Management for Non-Project Managers -Managing and Controlling the Project
Project Management for Non-Project Managers -Managing and Controlling the Project

$150.00

Overview: Successful projects require continued care and management to ensure that the project follows the plans correctly and, as a result, leads to the ...

Training in Human Error Reducing Training Related Errors
Training in Human Error Reducing Training Related Errors

$150.00

Overview: You will gain an understanding of the underlying causes of human error and how to reduce its occurrence by changing the culture of the organi...

Computer System Validation
Computer System Validation

$150.00

Overview: FDA requires that all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely...

BREXIT - Whats Changing for Life Science Product License Holders-Manufacturers and What You Need to Do Right Now
BREXIT - Whats Changing for Life Science Product License Holders-Manufacturers and What You Need to Do Right Now

$150.00

Overview: The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union. This means that unless a withdrawal agre...

Change Control Procedures in Regulated Industries
Change Control Procedures in Regulated Industries

$150.00

Overview: In this webinar, change control procedures within quality management systems (QMS) for documentation and information technology systems will ...

3-Hour Virtual Seminar FDA's New Draft Guidance on Software and Device Changes and the 510(k)
3-Hour Virtual Seminar FDA's New Draft Guidance on Software and Device Changes and the 510(k)

$290.00

Overview: A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, subs...

What you need to know to Meet FDA and International Quality Standards
What you need to know to Meet FDA and International Quality Standards

$150.00

Overview: This webinar will take you through the primary sources of compressed air contamination. It will also detail GMP standards and requirements pe...

Project Management for Non-Project Managers - Building the Project Team
Project Management for Non-Project Managers - Building the Project Team

$150.00

Overview: The subject of this webinar is building the project team, The key to achieving success with your project is the people you assign to it, how ...

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 134852016 Expectations
EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 134852016 Expectations

$150.00

Overview: It includes specific insights from direct involvement and work within the EU and the Commission's major improvement objectives to their system ...

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

$150.00

Overview: This is the most powerful of the risk management techniques because it considers risks in normal operation as well as fault conditions. FMEA and ...

cfourall logo
cfourall logo

$150.00

Overview: Project risk is greater the longer your project lasts, the longer the time between preparing your project plan and starting the work, the less experi...

Controlling Human Error in the Manufacturing Floor
Controlling Human Error in the Manufacturing Floor

$150.00

Overview: This course offers practical approaches and models to address human performance issues in GMP related environments by using a specific methodology to...

FDA's New Enforcement of 21 CFR Part 11
FDA's New Enforcement of 21 CFR Part 11

$150.00

Overview: The webinar will have the answers. In addition, using industry proven case studies on how to avoid 483 inspectional observations and warning letters ...

cGMPs in the Quality Control Laboratory
cGMPs in the Quality Control Laboratory

$150.00

Overview: In this webinar we will apply one aspect of this proactive approach, the review regulatory requirements and analysis of 483 and Warning Letter observ...

Quality Agreements Made Easy
Quality Agreements Made Easy

$150.00

Overview: The requirements for the assurance of quality within networks and circles of entities whose responsibilities are increasing specialized present an es...

Project Management for Non-Project Managers - Estimating Resource Needs
Project Management for Non-Project Managers - Estimating Resource Needs

$150.00

Overview: This webinar will explore how to most effectively apply both the human and non-human resources to project tasks that you require to achieve your proj...

Compliance for Risk Based Approaches for Clinical Trials
Compliance for Risk Based Approaches for Clinical Trials

$150.00

Overview: FDA and EMA have communicated their expectations for trial oversight/ monitoring, monitoring systems, and investigative site oversight. These are des...

cfourall logo
cfourall logo

$150.00

Overview: This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to p...

Managing and Examining Travel and Entertainment Expense
Managing and Examining Travel and Entertainment Expense

$150.00

Overview: This course provides insight on how to bring control and intelligent management to your company's T&E process.We evaluate how to bring people, pr...

21 CFR Part 11 - Compliance for Electronic Records and Signatures
21 CFR Part 11 - Compliance for Electronic Records and Signatures

$150.00

Overview: Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product fea...

Tools for Human Error Reduction
Tools for Human Error Reduction

$150.00

Overview: This course offers practical approaches and tools to address human performance issues in GMP related environments by using a specific methodology to ...

Preparing for an FDA Inspection - What you Need to Know
Preparing for an FDA Inspection - What you Need to Know

$150.00

Overview: Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading ...

FDA's Revolutionary Change in Software Regulation
FDA's Revolutionary Change in Software Regulation

$150.00

Overview: It is not about giving an OK to products, it is about trusting the manufacturer to do the right thing. Overall, your regulatory approach to software ...

What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections
What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections

$150.00

Overview: This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved a...

3-Hour Virtual Seminar on Verification vs Validation-Product, Process or Equipment and QMS Software
3-Hour Virtual Seminar on Verification vs Validation-Product, Process or Equipment and QMS Software

$290.00

Overview: You will learn What do the U.S. FDA and EU Expect for Verification and Validation, Actions and documentation to meet U.S. FDA CGMP, ICH Q-series, and...

Design Control Basics
Design Control Basics

$150.00

Overview: This 90-minute webinar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices th...

3-hour Virtual Seminar on Data Integrity Compliance with 21 CFR Part 11 and SaaSCloud Software Applications
3-hour Virtual Seminar on Data Integrity Compliance with 21 CFR Part 11 and SaaSCloud Software Applications

$290.00

Overview: This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity. Are...

3-Hour Virtual Seminar on Deciding When to Submit a 510(k) for a Change to an Existing Device
3-Hour Virtual Seminar on Deciding When to Submit a 510(k) for a Change to an Existing Device

$150.00

Overview: This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k)...

Excel Spreadsheets for 21 CFR 11 Compliance
Excel Spreadsheets for 21 CFR 11 Compliance

$150.00

Overview: Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regula...

Good Documentation Practices to Support FDA Computer System Validation
Good Documentation Practices to Support FDA Computer System Validation

$150.00

Overview: We will cover the importance of maintaining the documentation from every computer system validation effort in a "current" state. The system must be m...

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