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FDA Inspections From SOP to 483-min
FDA Inspections From SOP to 483-min

$150.00

Overview: Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who shou...

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 live interactive presentation will also discuss the regulations associated with the detection, correction and prevention of human errors in GMP ...

Demystifying the Canadian Drug and Health Products Regulatory Landscape
Demystifying the Canadian Drug and Health Products Regulatory Landscape

$150.00

Overview: The focus will be on drugs, biologics and medical devices, We will also be providing an overview of how the regulatory landscape is currently evolvin...

Responsibility for Off-label Claims in Social Media-min
Responsibility for Off-label Claims in Social Media-min

$150.00

Overview: One big issue is how you patrol and control what someone else is saying about your product in a public forum. Once the off-label information is out t...

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...

Auditing Laboratories Conducting Assays Supporting Biologics
Auditing Laboratories Conducting Assays Supporting Biologics

$150.00

Overview: Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audit...

ISOIEC 170252017 Section 7 - Process Requirements and Section 8 - Management System Requirements
ISOIEC 170252017 Section 7 - Process Requirements and Section 8 - Management System Requirements

$150.00

Overview: How does the new standard impact laboratories that are already accredited and how do you ensure staff adherence and ongoing compliance to minimize co...

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

$290.00

Overview: FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or ta...

Save your Food Business!! - Business Continuity & Disaster Recovery
Save your Food Business!! - Business Continuity & Disaster Recovery

$150.00

Overview: This course will outline the issues that need to be considered in the preparing to respond to disasters, and will suggest ways to minimize impact to ...

How to Analyze Financial Statements
How to Analyze Financial Statements

$150.00

Overview: Grab a cup of coffee and join us to learn how to analyze the numbers, and use this intel to juice up virtually every facet of your organization's ope...

3-Hour Virtual Seminar on What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections
3-Hour Virtual Seminar on What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections

$290.00

Overview: Yet GMPs have been enshrined into law for many countries and a drug/biologic/medical device manufacturer should have a reasonable expectation of all ...

Implementing a Compliant Stability Program for Biologics
Implementing a Compliant Stability Program for Biologics

$150.00

Overview: Biologics, as well as small molecule pharmaceutical products, require expiry dating.The complex structure of large molecules presents greater opportu...

Conducting YOUR NEW 2019 Annual ACH Rules Compliance Audit- a Step-by-Step Guide
Conducting YOUR NEW 2019 Annual ACH Rules Compliance Audit- a Step-by-Step Guide

$150.00

Overview: The NACHA Operating Rules and Guidelines require that all participating depository financial institutions, third-party senders and third-party servic...

Overcoming Obstacles of the Canadian Drug Regulatory Landscape
Overcoming Obstacles of the Canadian Drug Regulatory Landscape

$150.00

Overview: Through this presentation, you will develop a comprehensive understanding of the Drug Approval Process and in parallel examine major misconceptions a...

Are you responsible for Enterprise Risk Management Compliance
Are you responsible for Enterprise Risk Management Compliance

$150.00

Overview: This webinar will explain how to conduct a compliance gap analysis for Enterprise Risk Management (ERM). Attendees will learn best practices to ensur...

FDA's Quality Metrics - Latest Advances
FDA's Quality Metrics - Latest Advances

$150.00

Overview: This is a very important webinar for the FDA who is planning to use the quality metrics as part of their risk based inspection process. Why should...

NEW NACHA Rule Third-Party Sender Registration - Are you in Compliance 
NEW NACHA Rule Third-Party Sender Registration - Are you in Compliance 

$150.00

Overview: The ODFI is responsible for the registration process for any Third-Party Senders and nested TPS; registration is also necessary even if there is no T...

ISO 62304 How to Create a Medical Software Development File
ISO 62304 How to Create a Medical Software Development File

$150.00

Overview: You will learn, how to apply the ISO 62304 in the medical software development process and how to create a medical software development file. Why ...

Business Continuity Management Architect and Implement Solution
Business Continuity Management Architect and Implement Solution

$150.00

Overview: We will cover how to identify, analyze and document the events and environmental surroundings that can adversely affect the organization. Why shou...

Statistical Hypothesis Tests Concepts and Applications
Statistical Hypothesis Tests Concepts and Applications

$150.00

Overview: This training program will cover statistical hypothesis testing concepts including: null and alternate hypotheses, test statistics, p-values, confide...

Quality Control for Microbiological Media and Reagents
Quality Control for Microbiological Media and Reagents

$150.00

Overview: This webinar will help you develop a quality control program that fits your microbiological laboratory's needs. We will explicitly not cover any sero...

Quality Risk Management Overview
Quality Risk Management Overview

$150.00

Overview: Attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM. Explain the level of risk based on seve...

Turn a Culture of Quality Into a Competitive Advantage
Turn a Culture of Quality Into a Competitive Advantage

$150.00

Overview: A culture of quality is a powerful tool for creating an effective and efficient Quality Management System. A culture of quality is not accidental but...

Controlled Document System for a Life Sciences Manufacturing Plant
Controlled Document System for a Life Sciences Manufacturing Plant

$150.00

Overview: Life science manufacturing plants have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by...

MDSAP - How to Implement MDSAP
MDSAP - How to Implement MDSAP

$150.00

Overview: How a smart implementation of these requirements in the quality management system is possible and finally how the audit for five countries (Australia...

Data Integrity Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR
Data Integrity Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR

$150.00

Overview: This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applica...

Strategies To Prevent Manufacture And Distribution Of Substandard Medications
Strategies To Prevent Manufacture And Distribution Of Substandard Medications

$150.00

Overview: In this webinar we will provide you with best practices that have been proven effective, and equip you with the means to advocate for these ideas wit...

FDA's New Import Program for 2019
FDA's New Import Program for 2019

$150.00

Overview: In this interactive session author will discuss about the FDA's required information for the PREDICT software screening prior to entry and Custom's H...

3 Hour Virtual Seminar on Mastering Excel Formulas and Functions
3 Hour Virtual Seminar on Mastering Excel Formulas and Functions

$290.00

Overview: Functions are built-in formulas that have been programmed to perform a specific calculation. They range from the simple such as SUM and AVERAGE (used...

Scrutinizing Test Method Validation (TMV)
Scrutinizing Test Method Validation (TMV)

$150.00

Overview: Those who work with process optimization and validation focus on optimizing a process and reducing variability. Those working on Test Method Validati...

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