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Home › Online Training ›  Documentation and Policy Management

Documentation and Policy Management Training - Live Webinars, Recordings & CDs

Learn the standards for documentation and management, maintain consistency with common law, regulatory requirements, ethical and current best practice requirements. On this page, browse a broad range of courses specially designed for you.
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Recorded/CD
ISO 9001:2000 1st, 2nd and 3rd Party Auditing & Implementation

ISO 9001:2000 1st, 2nd and 3rd Party Auditing & Implementation

  • Speaker: Mark Stevens
  • Product ID: 700060
  • Duration: 60 Min
In this ISO 9001:2000 Training Understand the ISO 9001:2000 standard requirements for 1st, 2nd and 3rd part audits.
CD/Recorded
$249
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Recorded/CD
Impact of Recent Immigration Developments on Employers

Impact of Recent Immigration Developments on Employers

  • Speaker: Sameer Khedekar
  • Product ID: 705344
  • Duration:
Recent changes impact not only the employment of foreign nationals, but the broader workforce comprised of green card holders and international travelers. Executive leadership is looking to compliance officers, legal departments and human resources to understand how these changes affect their company. Tune in to learn how to ensure your business is not adversely affected by changes in immigration legislation and policy.
CD/Recorded
$0
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Recorded/CD
Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

  • Speaker: Kenneth Christie
  • Product ID: 703635
  • Duration:
This training program will provide attendees with a better understanding of how the FDA conducts their audits and the areas of most focus. In addition, it provides a summary of common GMP deficiencies given to drug manufacturers, to use to evaluate one’s own practices. Finally, when given a regulatory audit finding, this webinar will review the top five items to remember when submitting your responses to them to avoid further questions.
CD/Recorded
$0
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Recorded/CD
How to Establish an Effective IT Governance, Risk and Compliance (GRC) Framework - Organization and Responsibilities

How to Establish an Effective IT Governance, Risk and Compliance (GRC) Framework - Organization and Responsibilities

  • Speaker: Michael C Redmond
  • Product ID: 704991
  • Duration:
This training program will discuss how to develop a great GRC program that ensures proper governance, risk management and compliance management of all IT systems and processes that support the business operations.
CD/Recorded
$0
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Recorded/CD
Particulates in Biological Products - Evolving Regulations for Testing in Clinical and Commercial Stages

Particulates in Biological Products - Evolving Regulations for Testing in Clinical and Commercial Stages

  • Speaker: Nanda Subbarao
  • Product ID: 701600
  • Duration:
This webinar will discuss the evolving regulatory requirments for testing Biologics injectibles for sub-visible Particulates.
CD/Recorded
$0
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Recorded/CD
Auditing Business Continuity Plans According to ISO 22301

Auditing Business Continuity Plans According to ISO 22301

  • Speaker: Michael C Redmond
  • Product ID: 704410
  • Duration:

This training will cover the best practices for implementing and auditing a Business Continuity Plan. The speaker will discuss the lifecycle of a BCP program with specific emphasis on Risk Assessment and Business Impact Analysis, Designing a living BCP & Testing & Maintenance. The program will also detail the various standards from FFIEC to ISO. Participants will understand what’s involved in a full BCP program and have insights based upon field experience that can be applied to Internal Audit work and BCP. The session will provide you with tools that you can bring back to your company to improve upon BCP programs & ability to audit them to provide targeted recommendations.
CD/Recorded
$0
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Recorded/CD
Excursion Studies to Support Transporting and Distributing Clinical and Commercial Products

Excursion Studies to Support Transporting and Distributing Clinical and Commercial Products

  • Speaker: Kim Huynh-Ba
  • Product ID: 704421
  • Duration:
This training program will highlight the key factors that affect stability profile of pharmaceutical products. Participants will learn how to make plan for extreme environments for transporting and distributing pharmaceutical products.
CD/Recorded
$0
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Recorded/CD
Annual Analytical Laboratory Data Integrity Training

Annual Analytical Laboratory Data Integrity Training

  • Speaker: Nanda Subbarao
  • Product ID: 705326
  • Duration:
This webinar will address the key elements of regulatory expectations for analytical laboratory data integrity. It will teach best practices to avoid 483s and warning letters issued by FDA related to data integrity issues.
CD/Recorded
$0
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Recorded/CD
Avoiding FDA observations: Do's and Don'ts during Laboratory Inspections

Avoiding FDA observations: Do's and Don'ts during Laboratory Inspections

  • Speaker: Kim Huynh-Ba
  • Product ID: 703278
  • Duration:
This training will provide the attendees best practices for handling FDA inspections to avoid form 483 and Warning Letters.
CD/Recorded
$0
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Recorded/CD
How to Buy COTS Software, and Audit and Validate Vendors

How to Buy COTS Software, and Audit and Validate Vendors

  • Speaker: David Nettleton
  • Product ID: 703820
  • Duration:
This training program will focus on instructing attendees on best practices for buying COTS (Commercial Off-The-Shelf) software and to evaluate a software vendor. It will also highlight key data and systems subject to Part 11, and list requirements for IT, SaaS, and cloud hosting.
CD/Recorded
$0
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Recorded/CD
Key Factors to Develop an Effective CAPA System

Key Factors to Develop an Effective CAPA System

  • Speaker: Kim Huynh-Ba
  • Product ID: 703320
  • Duration:
This training will focus on the regulatory requirements for a Corrective and Preventive Actions (CAPA) system. Attendees will learn how to develop an effective CAPA system.
CD/Recorded
$0
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Recorded/CD
GMP Requirements for Validation and Re-Validation of Analytical Procedures

GMP Requirements for Validation and Re-Validation of Analytical Procedures

  • Speaker: Kim Huynh-Ba
  • Product ID: 703041
  • Duration:
This webinar will explain the cGMP and ICH validation requirements for analytical procedures and discuss key factors that would affect validation process of analytical procedures. It will review the differences between validation and re-validation plan.
CD/Recorded
$0
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Recorded/CD
Hurricane Safety and Survival Tips - Severe Weather Precautions

Hurricane Safety and Survival Tips - Severe Weather Precautions

  • Speaker: John J Meola
  • Product ID: 705470
  • Duration:
This webinar will review the most critical safety elements associated with planning for, surviving and recovering from natural disasters, such as Hurricane Harvey we have seen recently in Texas. Learn how to protect yourself, your family and your employees, what to expect, and how to minimize the disruption from severe weather events.
CD/Recorded
$0
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Recorded/CD
Implementing and Auditing Business Continuity Plans

Implementing and Auditing Business Continuity Plans

  • Speaker: Michael C Redmond
  • Product ID: 704821
  • Duration:
This training program will provide an overview on how to create a business continuity audit plan that is effective and in line with the company's objectives. It will help attendees understand regulations, standards and requirements pertinent to business continuity audits as well. The webinar will define the risks or threats to the success of an audit plan and train attendees on how to test the controls in place to determine whether or not those risks are acceptable.
CD/Recorded
$249
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Recorded/CD
Developing a Highly Effective Enterprise Risk Management Program

Developing a Highly Effective Enterprise Risk Management Program

  • Speaker: Michael C Redmond
  • Product ID: 704827
  • Duration:
This webinar highlights the importance of an effective ERM program in project management and risk assessment. Attendees will learn how to implement a viable ERM program including documenting and testing it.
CD/Recorded
$0
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Recorded/CD
Managing your GMP Quality Control (QC) Labs in Compliance with FDA Regulations

Managing your GMP Quality Control (QC) Labs in Compliance with FDA Regulations

  • Speaker: Kim Huynh-Ba
  • Product ID: 705081
  • Duration:
This webinar will discuss the common deficiencies in relation to compliance and validation issues that typically found with pharmaceutical Quality Control labs.
CD/Recorded
$0
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Recorded/CD
Complying with FLSA - How to Determine Exempt Status & Calculate Overtime Correctly

Complying with FLSA - How to Determine Exempt Status & Calculate Overtime Correctly

  • Speaker: Susan Fahey Desmond
  • Product ID: 702717
  • Duration:
This webinar on employee overtime calculation will help you understand what is “time worked”, exempt versus non-exempt status and how to calculate your employees' overtime correctly so to avoid these costly suits.
CD/Recorded
$0
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Recorded/CD
Webinar - Latin America – Understanding Regulatory Compliance Requirements Across Life Science Industry PART I & PART II

Webinar - Latin America – Understanding Regulatory Compliance Requirements Across Life Science Industry PART I & PART II

  • Speaker: Robert J Russell
  • Product ID: 701350
  • Duration:
This Latin America Regulatory compliance requirement training/webinar will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.
CD/Recorded
$299
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