About compliance4all14@gmail.com

  • Member Since: June 2, 2016

Description

Ads / Latest items listed

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...

Electronic Records & Electronic Signatures, 21 CFR Part 11, Basic Concepts
Electronic Records & Electronic Signatures, 21 CFR Part 11, Basic Concepts

$150.00

Overview: This presentation will provide an overview and historical perspective of the Part 11 regulation, the general Part 11 requirements,electronic records ...

3-hour Virtual Seminar on Project Management for Non-Project Managers
3-hour Virtual Seminar on Project Management for Non-Project Managers

$290.00

Overview: This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project e...

CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

$150.00

Overview: This webinar will help you understand the critical ingredients for conducting an effective root cause analysis, also you will learn how to An...

Food Fraud in the Organic Industry
Food Fraud in the Organic Industry

$150.00

Overview: National Organic Program (NOP) standards were established in 2002. With almost every type of product now flying the "organic" flag from thous...

Japan Regulatory Filing Requirements and Compliance Processes for Life Sciences
Japan Regulatory Filing Requirements and Compliance Processes for Life Sciences

$150.00

Overview: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biolo...

21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

$150.00

Overview: This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and ...

HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms
HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms

$150.00

Overview: The webinar provides valuable information on differential pressure, air velocity , flow rates, and air pressure balancing. Temperature and re...

Introduction to Good Manufacturing Practices (GMP)
Introduction to Good Manufacturing Practices (GMP)

$150.00

Overview: Among those educational requirements are a course in Introductory GMP upon employment at a pharmaceutical company, and annual refresher GMP t...

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

$150.00

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

Oversight of CROs-Vendors-CMOs
Oversight of CROs-Vendors-CMOs

$150.00

Overview: It is essential for industry to employ efficient and accurate strategies for monitoring outsourced projects to minimize the chances of receiv...

Successful Supplier Audits
Successful Supplier Audits

$150.00

Overview: This webinar is designed to provide the participants a working knowledge of supplier audits. The why, when, who, how, and what of conducting ...

Corrective and Preventive Action (CAPA) per FDA Requirements
Corrective and Preventive Action (CAPA) per FDA Requirements

$150.00

Overview: In this webinar, we will review CAPA as part of Quality Management System (QMS), reasons why organizations need to use CAPA, what is its purp...

The Safety Maturity Curve - Where Does your Organization Stand
The Safety Maturity Curve - Where Does your Organization Stand

$150.00

Overview: We will discuss the pro's and con's of a implementing a zero incident workplace culture and describe how to determine if you are doing it rig...

3-Hour Virtual Seminar on Off label Promotion
3-Hour Virtual Seminar on Off label Promotion

$290.00

Overview: This session sets the context for the off-label promotion of medical products starting with early history and moving to the most recent histo...

Criteria for IRB Approval - Essential Training for IRB Members and Staff 
Criteria for IRB Approval - Essential Training for IRB Members and Staff 

$150.00

Overview: This webinar serves will provide substantive training of the criteria for IRB approval for new IRB members/staff who have less than three yea...

Networking for Fun and Profit
Networking for Fun and Profit

$150.00

Overview: Most people lack the basic networking skills necessary to do their jobs properly. These networking skills help us in many areas of our jobs. Why s...

Setting Specifications for Drug Substances and Drug Products
Setting Specifications for Drug Substances and Drug Products

$150.00

Overview: This program will teach you to set specificatons for drug substance and drug product,including use of release test data, long term stability, acceler...

Building Your Company FDA FSMA Preventive Control Food Safety Plan
Building Your Company FDA FSMA Preventive Control Food Safety Plan

$150.00

Overview: The plan must also include a hazard analysis, allergen analysis, factory profile, recall plan, supply chain controls, process preventive controls, sa...

Manufacturing Safety What you don't Know can Harm you
Manufacturing Safety What you don't Know can Harm you

$150.00

Overview: In this webinar, we will explore the hazards related to the manufacturing facility on many fronts. To understand the plant work environment as it rel...

Investigator Reporting Responsibilities
Investigator Reporting Responsibilities

$150.00

Overview: The webinar will also discuss how to make determinations of whether an adverse event is probably related, possibly related, or possibly/probably not ...

Page 1 of 71 2 3 7