ComplianceOnline
Change Management - Managing Effective Change and Eliminating Unwanted Changes
9
/ Apr
Thursday-2020

Change Management - Managing Effective Change and Eliminating Unwanted Changes

  • Speaker: David Husman
  • Product ID: 706420
  • Duration: 90 Min
Change Management is one of the most critical quality systems a company can have. Well managed systems are effective in implementing desired changes and preventing unwanted modifications to validated processes. This webinar will discuss the requirements for change management, the steps for effective change management and the actions companies can take to ensure unwanted changes do not occur in their operations.
* Per Attendee
$249
Product Stability Testing Program - Designing and Sustaining New and Existing Programs
9
/ Apr
Thursday-2020

Product Stability Testing Program - Designing and Sustaining New and Existing Programs

  • Speaker: Charity Ogunsanya
  • Product ID: 703000
  • Duration: 90 Min
This life science product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.
* Per Attendee
$249
Handling OOS Test Results and Completing Robust Investigations
9
/ Apr
Thursday-2020

Handling OOS Test Results and Completing Robust Investigations

  • Speaker: Danielle DeLucy
  • Product ID: 704351
  • Duration: 90 Min
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
* Per Attendee
$249
Validation of HPLC/UPLC Methodologies
14
/ Apr
Tuesday-2020

Validation of HPLC/UPLC Methodologies

  • Speaker: John Fetzer
  • Product ID: 705291
  • Duration: 60 Min
This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.
* Per Attendee
$229
Understanding FDA Import Alerts:  What Are They and Recommendations For Removing Your Company And Products From An Alert
23
/ Apr
Thursday-2020

Understanding FDA Import Alerts: What Are They and Recommendations For Removing Your Company And Products From An Alert

  • Speaker: Karl M. Nobert
  • Product ID: 703313
  • Duration: 90 Min
This webinar provides attendees with an introduction to FDA Import Alerts and what they are, examine why they are issued, show you where to locate them and how to determine whether a company or product is on one, and finally, provide strategic recommendations for removal from an alert.
* Per Attendee
$249
Data Integrity - It's Not New and So Much More than Just Computers
23
/ Apr
Thursday-2020

Data Integrity - It's Not New and So Much More than Just Computers

  • Speaker: David Husman
  • Product ID: 706410
  • Duration: 60 Min
This webinar will discuss the recent attention regulators have placed on data integrity and show how the requirements are not new. The sources of data issues go far beyond the laboratory and are not just found in computer/electronic systems.
* Per Attendee
$229
Root Cause Analysis - The Heart of Corrective Action
23
/ Apr
Thursday-2020

Root Cause Analysis - The Heart of Corrective Action

  • Speaker: Betty Lane
  • Product ID: 703391
  • Duration: 75 Min
This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.
* Per Attendee
$229
Bioanalytical Methods Validation
29
/ Apr
Wednesday-2020

Bioanalytical Methods Validation

  • Speaker: Edward O Connor
  • Product ID: 701769
  • Duration: 60 Min
This training on bio-analytical methods validation will help you to understand the FDA and EMA guidance for Instrumental, ligand binding and cell-based assays and also review of recent 483s impacting validation.
* Per Attendee
$229
Deviation Management - Why Have We Not Solved the Problem?
5
/ May
Tuesday-2020

Deviation Management - Why Have We Not Solved the Problem?

  • Speaker: David Husman
  • Product ID: 706413
  • Duration: 60 Min
This webinar will discuss the causes for failure in our deviation systems and recommendations to successfully take a different approach that results in problems finally being solved.
* Per Attendee
$229
Human Error and Cognitive Load: How to Reduce Memory and Attention Failures
12
/ May
Tuesday-2020

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

  • Speaker: Ginette M Collazo
  • Product ID: 704210
  • Duration: 60 Min
This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.
* Per Attendee
$229
The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory
20
/ May
Wednesday-2020

The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory

  • Speaker: John Fetzer
  • Product ID: 706183
  • Duration: 60 Min
Attend this webinar to learn how to understand control charts and their underlying statistics, how to choose variables to monitor, how to maintain the records and to plan adjustments. There will be examples and walkthroughs of control chart implementation and use. A review of the relevant statistics will also be done.
* Per Attendee
$229
Risk Management - A Process Flow Approach to Converting a Guidance into an SOP
21
/ May
Thursday-2020

Risk Management - A Process Flow Approach to Converting a Guidance into an SOP

  • Speaker: David Husman
  • Product ID: 706414
  • Duration: 60 Min
Attend this webinar to learn how to translate a new guidance or regulation into a working process, and how to use process flow, techniques and templates to develop procedures on your own. The webinar will provide you with a working SOP for Risk Management.
* Per Attendee
$229
Building a Compliant Laboratory - From Foundation to Business Excellence
10
/ Jun
Wednesday-2020

Building a Compliant Laboratory - From Foundation to Business Excellence

  • Speaker: David Husman
  • Product ID: 706396
  • Duration: 90 Min
Everyone struggles with getting their laboratory into compliance. Learn how to build a compliant laboratory from starting with a good foundation to implementing for Business Excellence. Dr. Husman’s presentation will walk you through the process and steps needed to ensure a compliant laboratory is built or rebuilt for business excellence.
* Per Attendee
$249
FDA's Ambitious Regulation of Social Media
16
/ Jun
Tuesday-2020

FDA's Ambitious Regulation of Social Media

  • Speaker: Casper Uldriks
  • Product ID: 703853
  • Duration: 60 Min
FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.
* Per Attendee
$229
Implementation and Management of GMP Data Integrity
18
/ Jun
Thursday-2020

Implementation and Management of GMP Data Integrity

  • Speaker: Danielle DeLucy
  • Product ID: 705029
  • Duration: 90 Min
Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.
* Per Attendee
$249
Recorded/CD
Basic Laboratory Skills

Basic Laboratory Skills

  • Speaker: Mark Powell
  • Product ID: 706286
  • Duration: 60 Min
Accurate measurement of weight and correct use of volumetric apparatus are prerequisites for valid analytical measurement. This webinar covers the quality-critical aspects of both. It is intended for new starters in industrial analytical laboratories or for other staff who would benefit from refresher training.
Recorded/CD
Sterilization of Pharmaceutical Products and Medical Devices

Sterilization of Pharmaceutical Products and Medical Devices

  • Speaker: Carl Patterson
  • Product ID: 705310
  • Duration: 90 Min
This webinar will discuss in detail the methods of sterilization to be used on medical devices and pharmaceutical products including advantages and disadvantages of each method. Also attendees will understand the regulations pertaining to sterilization of products that will help to decide with method to use for their product. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.
CD/Recorded
$299
Recorded/CD
How to Prepare a Standard Operating Procedure (SOP)?

How to Prepare a Standard Operating Procedure (SOP)?

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705131
  • Duration: 60 Min
This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.
CD/Recorded
$299
Recorded/CD
Starting a New Lab for Chemical Analysis

Starting a New Lab for Chemical Analysis

  • Speaker: James Peterson
  • Product ID: 706306
  • Duration: 60 Min
In this webinar the presenter will draw upon his experience in starting new private, contract research, state and federal government laboratories and laboratory subdivisions to elaborate the numerous aspects of developing a plan to open a new analytical lab for business in a reasonable amount of time.
Recorded/CD
The Use of Monitoring and Statistics to Prevent Non-Compliance in the Laboratory

The Use of Monitoring and Statistics to Prevent Non-Compliance in the Laboratory

  • Speaker: John Fetzer
  • Product ID: 705292
  • Duration: 60 Min
This webinar will cover the basic statistics of compliance and non-compliance and how to use a statistical approach to monitor the operation in the laboratory.
CD/Recorded
$249
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