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  • Member Since: June 2, 2016

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Aseptic Processing Overview and Validation
Aseptic Processing Overview and Validation

$150.00

Overview: This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contaminat...

Equipment Validation, Tracking, Calibration and Preventive Maintenance
Equipment Validation, Tracking, Calibration and Preventive Maintenance

$150.00

Overview: Prior to use, however, this equipment must be validated to make sure it produces product that meets its specifications. There are ways, thoug...

European Data Protection Regulation - Latest
European Data Protection Regulation - Latest

$150.00

Overview: Learn the common EU rules that have been established to ensure that personal data has a high standard of protection across the EU. Why should ...

Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to Meet FDA and International Quality Standards
Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to Meet FDA and International Quality Standards

$150.00

Overview: Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the ...

Current Trends in CyberSecurity Threats to Medical Devices
Current Trends in CyberSecurity Threats to Medical Devices

$150.00

Overview: In this webinar, you will learn just how cyberattacks threaten medical devices and how industry is currently responding to them. Why should yo...

Human Machine Interface and Alarm Handling
Human Machine Interface and Alarm Handling

$150.00

Overview: The Human Machine Interface within a control room is the main (and in some cases only) interface and operator has with the rest of a system. ...

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

$150.00

Overview: This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to uti...

Food Safety - Food Defense
Food Safety - Food Defense

$150.00

Overview: Food Safety Modernization Act of 2010 was signed into law by President Obama on January 4, 2011, Food Defense is now clearly called out and m...

Good Documentation Guideline (Chapter 1029 USP)
Good Documentation Guideline (Chapter 1029 USP)

$150.00

Overview: This session will wrap up the general concept and will provide information as to what needs to be documented in certain records. Why should yo...

Onboarding Employees in a GMP Environment Best Practices for Foundational Employee Success
Onboarding Employees in a GMP Environment Best Practices for Foundational Employee Success

$150.00

Overview: FDA expectations provide some of the framework regarding types and frequency of training, there are decisions that the company will need to make in l...

Fishbone Diagramming
Fishbone Diagramming

$150.00

Overview: Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addi...

Medical Devices - Complying With 820.250 Statistical Methods
Medical Devices - Complying With 820.250 Statistical Methods

$150.00

Overview: In this webinar you will learn how to structure your statistical procedures to ensure compliance, and how to avoid these and how to fully comply with...

3-Hour Virtual Seminar on Risk Based Incident Management and CAPA for GxP Computerized Systems Operations
3-Hour Virtual Seminar on Risk Based Incident Management and CAPA for GxP Computerized Systems Operations

$290.00

Overview: This Webinar specifically addresses the Incident Management and CAPA processes of the Operations phase of GxP Computerized Systems and describes the ...

Excel as a BI Tool - Power Pivot and Power Query 101
Excel as a BI Tool - Power Pivot and Power Query 101

$150.00

Overview: Power Pivot puts the "power" into Pivot Tables (hence the name!), removing many of limitations and frustrations that many advanced users find with Pi...

3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements
3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements

$290.00

Overview: How to develop or improve upon a Master Verification and Validation Plan and System that meets U.S. FDA CGMP, ICH Q-series, and ISO 13485 expectation...

Time-Saving Excel Tips, Tricks and 100 Shortcuts
Time-Saving Excel Tips, Tricks and 100 Shortcuts

$150.00

Overview: This webinar will give you the productivity boost you need as you become a more proficient Excel user. Why should you Attend: This session presen...

If it Isn't Written Down, then it Didn't Happen Complying with FDA's Good Documentation Practices
If it Isn't Written Down, then it Didn't Happen Complying with FDA's Good Documentation Practices

$150.00

Overview: In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety. W...

Going from Raw Data to Great Results with Excel PowerPivot and PowerQuery
Going from Raw Data to Great Results with Excel PowerPivot and PowerQuery

$150.00

Overview: If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data ...

3-Hour Virtual Seminar on Excel Spreadsheet Validation for FDA 21 CFR Part 11
3-Hour Virtual Seminar on Excel Spreadsheet Validation for FDA 21 CFR Part 11

$290.00

Overview: These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally...

Excel Formulas and Functions 101
Excel Formulas and Functions 101

$150.00

Overview: Functions are built-in formulas that have been programmed to perform a specific calculation. They can often be used to shorten and simplify what woul...

Water System Mythology Common False Beliefs for Microbial Control and Monitoring
Water System Mythology Common False Beliefs for Microbial Control and Monitoring

$150.00

Overview: In this webinar a number of water system myths will be discussed that are related to microbial control approaches as well as microbial monitoring. ...

Design History Files
Design History Files

$150.00

Overview: It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two differe...

Mastering Excel Pivot Tables
Mastering Excel Pivot Tables

$150.00

Overview: You will also learn how to create a pivot table from multiple tables and multiple data sources, including linking to external data. Why should you...

Audit Trail Generation and Review
Audit Trail Generation and Review

$150.00

Overview: These electronic records must be maintained according to regulatory requirements contained within FDA's 21 CFR Part 11 for US jurisdictions and Eudra...

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...

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