ComplianceOnline
HACCP - Conducting Effective Hazard Analysis
9
/ Jul
Thursday-2020

HACCP - Conducting Effective Hazard Analysis

  • Speaker: Charles H Paul
  • Product ID: 706529
  • Duration: 90 Min
HACCP Hazard Analysis and Critical Control Points is a management system in which product safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. HACCP is aimed at prevention of contamination, instead of end-product evaluation.
* Per Attendee
$349
Batch Record Review and Product Release
9
/ Jul
Thursday-2020

Batch Record Review and Product Release

  • Speaker: Danielle DeLucy
  • Product ID: 705921
  • Duration: 60 Min
In this webinar attendees will learn the fundamentals for reviewing batch records in a pharmaceuticals, biologics and medical devices environment. Attendees will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of these critical documents and also they will learn how to react to discrepancies found in these records.
* Per Attendee
$229
Corona Virus - 19:  New Risks with FDA Imports Logistics
9
/ Jul
Thursday-2020

Corona Virus - 19: New Risks with FDA Imports Logistics

  • Speaker: Casper Uldriks
  • Product ID: 706442
  • Duration: 60 Min
Importing FDA regulated product faces new challenges, new risk management procedures, and mitigation of business consequences that will affect corporate profits. Basic issues should be evaluated and updated to help you plan for unprecedented problems and your helplessness to escape the trauma. The COVID-19 creates a global bondage on commerce and drains, if not dries up, the supply of necessary products to protect the health and well fare of your customer base, which actually is the entire U.S. population. In this webinar, you will mentally travel through your import process, how it will or can be derailed and identify issues you need to evaluate during the current interruption of your standard import business.
* Per Attendee
$329
Implementing a Robust Data Integrity Program
13
/ Jul
Monday-2020

Implementing a Robust Data Integrity Program

  • Speaker: Kelly Thomas
  • Product ID: 706178
  • Duration: 90 Min
This webinar will detail a data integrity governance program and principles for defining quality and data integrity into processes and systems. It will cover the common problems from FDA 483 observations and warning letters and teach you how to avoid them.
* Per Attendee
$249
Good Documentation Guideline (Chapter <1029> USP)
14
/ Jul
Tuesday-2020

Good Documentation Guideline (Chapter <1029> USP)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705130
  • Duration: 60 Min
This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
* Per Attendee
$229
Solving Statistical Mysteries - What Does FDA Want?
20
/ Jul
Monday-2020

Solving Statistical Mysteries - What Does FDA Want?

  • Speaker: Ron Snee
  • Product ID: 706371
  • Duration: 90 Min

This webinar provides some practical and useful answers to the question

"What Kind of Statistical Methods and Tools Does the FDA Want Pharma to Use?"

FDA’s guidances and regulations have emphasized the use of statistics for many years. Statistical thinking and methods is an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Even with this long history, the use of statistics seems to be a source of uncertainty and anxiety for many. This presentation provides an overview of what it appears the FDA is looking for in the use statistics including examples and recommended approaches.

* Per Attendee
$249
Japan: Regulatory Compliance Requirements for Life Science Products
21
/ Jul
Tuesday-2020

Japan: Regulatory Compliance Requirements for Life Science Products

  • Speaker: Robert J Russell
  • Product ID: 702979
  • Duration: 90 Min
This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.
* Per Attendee
$249
FDA Compliance for Mobile Applications
22
/ Jul
Wednesday-2020

FDA Compliance for Mobile Applications

  • Speaker: Eleonora Babayants
  • Product ID: 706490
  • Duration: 60 Min
Attend this webinar to understand the FDA guidance for mobile applications. We will discuss the key areas that are most important during inspection and audit, including security, data integrity, validation, training, and documentation. We will pay special attention on the issue of validation of mobile applications.
* Per Attendee
$229
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
22
/ Jul
Wednesday-2020

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

  • Speaker: David Nettleton
  • Product ID: 701582
  • Duration: 75 Min
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
* Per Attendee
$229
USDA New Proposed Rule on BioEngineered (GMO) Food Disclosure
23
/ Jul
Thursday-2020

USDA New Proposed Rule on BioEngineered (GMO) Food Disclosure

  • Speaker: Kelly Thomas
  • Product ID: 706164
  • Duration: 60 Min
Attend this webinar to learn how to be fully compliant with the USDA Final Rule on Bioengineered Food Disclosure, disclosure requirements in product labeling; disclosure options available to food manufacturers and distributors; symbols to be used and graphic requirements; and the timelines for compliance.
* Per Attendee
$229
The Mindset of an FDA Employee
23
/ Jul
Thursday-2020

The Mindset of an FDA Employee

  • Speaker: Larry Stevens
  • Product ID: 706174
  • Duration: 60 Min
If you develop or manufacture a product regulated by FDA you will need to interact with FDA employees. It is important to interact with the FDA employee in the most productive manner. But there is a variable you must deal with that will determine how productive your interaction is. The variable is the FDA employee. That is the purpose of this webinar.
* Per Attendee
$229
Leverage Regulatory Documentation - Write SOPs That Work and Have Value
23
/ Jul
Thursday-2020

Leverage Regulatory Documentation - Write SOPs That Work and Have Value

  • Speaker: Charles H Paul
  • Product ID: 706530
  • Duration: 60 Min
Compliance documentation to include Standard Operating Procedures – the documentation required by regulation – is essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purposes other than meeting a regulatory requirement – as training materials, to standardize operations, to manage individual and group performance, to identify the sources of deviations, etc. The key is to knowing how to write those documents to properly meet those needs.
* Per Attendee
$329
Coronavirus and a New Member of This Family (COVID-19) - What You Need to Know
28
/ Jul
Tuesday-2020

Coronavirus and a New Member of This Family (COVID-19) - What You Need to Know

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 706525
  • Duration: 90 Min
There is a lot of information circulating online about COVID-19 and there is a lot of confusion around what will happen to individuals, what this new enemy is that has suddenly appeared in our midst, interrupted/threatened our lives and what to do to stay safe. The goal of this webinar it to provide clear information to demystify COVID-19 and provide a platform to answer questions. The content is scientific in nature but simplified for people so that people without a strong scientific background can understand the content.
* Per Attendee
$349
Trends in FDA Compliance and Enforcement for Regulated Systems
28
/ Jul
Tuesday-2020

Trends in FDA Compliance and Enforcement for Regulated Systems

  • Speaker: Carolyn Troiano
  • Product ID: 706353
  • Duration: 90 Min
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.
* Per Attendee
$229
Steam Sterilization Microbiology and Autoclave Performance Qualification
6
/ Aug
Thursday-2020

Steam Sterilization Microbiology and Autoclave Performance Qualification

  • Speaker: Danielle DeLucy
  • Product ID: 705027
  • Duration: 60 Min
In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.
* Per Attendee
$229
Recorded/CD
Leadership Skills in a GMP Laboratory

Leadership Skills in a GMP Laboratory

  • Speaker: Rob MacCuspie
  • Product ID: 706423
  • Duration: 60 Min
Scientists are often thrust into leadership roles after demonstrating technical excellence. With a growth mindset, this creates the opportunity to develop leadership skills specific to people management of scientific types. This presentation will highlight how leadership principles apply in a GMP Laboratory environment.
CD/Recorded
$299
Recorded/CD
Change Control for FDA Regulated Industries

Change Control for FDA Regulated Industries

  • Speaker: Eleonora Babayants
  • Product ID: 706432
  • Duration: 90 Min
GxP/GMP regulations are required to be used in regulated industries such as food and beverages, pharmaceutical, medical devices, and cosmetics. According to these regulations, change control procedures have to be used. Change control within Quality Management System (QMS) and Information Technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. In the regulated industries, manufactures are required to use a change control procedure. Change control procedures reduce the possibility that unnecessary changes will be introduced to a system without analysis, introducing faults into the system or undoing changes made by other users of software.
CD/Recorded
$399
Recorded/CD
Structuring and Conducting Risk-Based Internal cGMP Compliance Audits

Structuring and Conducting Risk-Based Internal cGMP Compliance Audits

  • Speaker: John E Lincoln
  • Product ID: 701432
  • Duration: 60 Min
This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits.
CD/Recorded
$299
Recorded/CD
Data Integrity and Governance for Computer Systems Regulated by FDA

Data Integrity and Governance for Computer Systems Regulated by FDA

  • Speaker: Carolyn Troiano
  • Product ID: 706352
  • Duration: 90 Min
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. In this webinar, you will learn about these FDA trends in compliance and enforcement, as they relate to data integrity, and how to improve your practices to meet compliance requirements.
CD/Recorded
$299
Recorded/CD
Implementing a Bullet Proof Quality System for FDA Audit Success

Implementing a Bullet Proof Quality System for FDA Audit Success

  • Speaker: Meena Chettiar
  • Product ID: 705400
  • Duration: 60 Min
This webinar will provide an overview of the FDA expectations in medical device industries for setting up a quality system for FDA audit readiness. It will also provide an understanding of the quality system inspection techniques (QSIT) requirements for documents controls, production and process controls, packaging and labeling controls and more.
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