ComplianceOnline
Product Stability Testing Program - Designing and Sustaining New and Existing Programs
9
/ Dec
Monday-2019

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
FDA Inspections: Understanding the Core Elements – Part I
12
/ Dec
Thursday-2019

FDA Inspections: Understanding the Core Elements – Part I

  • Speaker: Vanessa Lopez
  • Product ID: 706256
  • Duration: 120 Min
Attend this course to learn the rationale, strategies and flow on how to plan for an FDA inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.
* Per Attendee
$299
Preparing for and Responding Effectively In a Positive Manner to an FDA Postmarket Surveillance Visit
16
/ Dec
Monday-2019

Preparing for and Responding Effectively In a Positive Manner to an FDA Postmarket Surveillance Visit

  • Speaker: George Yanulis
  • Product ID: 706295
  • Duration: 90 Min
Premarket Approvals Premarket approval (PMA) are required by The Food and Drug Administration is the regulatory protocol presently used to evaluate the safety and effectiveness of Class III medical devices, e.g., an implantable cardioverter defibrillator (ICD). This webinar will help you understand the nature, severity, or frequency of suspected problems reported in adverse event reports or in the published literature. The information when applied is most effective in reducing potential adverse events.
* Per Attendee
$249
Good Documentation Practice (GDocP) for FDA Regulated Industry
16
/ Dec
Monday-2019

Good Documentation Practice (GDocP) for FDA Regulated Industry

  • Speaker: Eleonora Babayants
  • Product ID: 705782
  • Duration: 90 Min
This good documentation practice webinar will discuss how to secure, manage and govern your documentation in compliance with GxP/GMP requirements and be able to pass quality audit. Also attendees will learn the connection between CxP/GMP and document control, which documents need to be controlled and which are not, what documentation required for QMS, how QA can plays an important role in documentation systems and how change control procedure used in GxP/GMP environment.
* Per Attendee
$199
FDA: Mock and Pre-Approval Inspections (PAIs) - Part II
17
/ Dec
Tuesday-2019

FDA: Mock and Pre-Approval Inspections (PAIs) - Part II

  • Speaker: Vanessa Lopez
  • Product ID: 706258
  • Duration: 120 Min
This course for pharmaceutical professionals provides the information they require, to prepare for and understand what will happen during a mock audit and during a Pre-Approval Inspection (PAI).
* Per Attendee
$299
What To Expect From FDA’s New Approach to Regulate Medical Software
17
/ Dec
Tuesday-2019

What To Expect From FDA’s New Approach to Regulate Medical Software

  • Speaker: Dennis Weissman
  • Product ID: 706085
  • Duration: 60 Min
The FDA’s emerging approach to medical software product regulation has important ramifications for patients, healthcare providers and insurers as well as product developers. So, it is critically important for companies throughout the life sciences and healthcare industries that utilize software in its products to understand the important challenges and opportunities presented by this major policy shift. This webinar will provide understanding.
* Per Attendee
$229
Handling OOS Test Results and Completing Robust Investigations
17
/ Dec
Tuesday-2019

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
Annual Current Good Manufacturing Practices (cGMP) Training
18
/ Dec
Wednesday-2019

Annual Current Good Manufacturing Practices (cGMP) Training

  • Speaker: Kelly Thomas
  • Product ID: 705422
  • Duration: 60 Min
This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.
* Per Attendee
$199
Drug Manufacturing Inspection Part III
19
/ Dec
Thursday-2019

Drug Manufacturing Inspection Part III

  • Speaker: Vanessa Lopez
  • Product ID: 706259
  • Duration: 120 Min
Attend this course to prepare for and understand what will happen during a Drug Manufacturing Inspection for Surveillance Inspections. It will explain the FDA criteria to perform a For Cause Inspection.
* Per Attendee
$299
Supplier and Service Provider Controls: FDA Expectations
9
/ Jan
Thursday-2020

Supplier and Service Provider Controls: FDA Expectations

  • Speaker: Vanessa Lopez
  • Product ID: 704844
  • Duration: 120 Min
This training program will provide regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry and illustrate the same with examples. It will furnish details on what purchasing/supplier control management systems should address.
* Per Attendee
$299
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
14
/ Jan
Tuesday-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
Understanding the Role of your Expert Witness
15
/ Jan
Wednesday-2020

Understanding the Role of your Expert Witness

  • Speaker: George Yanulis
  • Product ID: 706296
  • Duration: 90 Min
This webinar will provide you a thorough background into the FDA regulatory and EU control issue related to the specific device required to provide expert opinions.
* Per Attendee
$249
4-Hr Virtual Training: How to Respond to an FDA Investigation
16
/ Jan
Thursday-2020

4-Hr Virtual Training: How to Respond to an FDA Investigation

  • Speaker: Joy McElroy
  • Product ID: 704549
  • Duration: 4 hrs
This FDA investigation training program will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by the FDA and define processes for preparing for FDA audits.
* Per Attendee
$399
Sample Size Determination for Design Validation Activities
16
/ Jan
Thursday-2020

Sample Size Determination for Design Validation Activities

  • Speaker: Steven Wachs
  • Product ID: 705852
  • Duration: 75 Min
Statistical Methods are typically used to ensure that product performance, quality, and reliability requirements are met during the Design Validation phase of product development. This webinar discusses common elements of sample size determination and several specific sample size applications for various design validation activities including Reliability Demonstration/Estimation, Acceptance Sampling, and Hypothesis Testing.
* Per Attendee
$229
Good Documentation Guideline (Chapter <1029> USP)
22
/ Jan
Wednesday-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
Recorded/CD
Introduction to Root Cause Investigation for CAPA

Introduction to Root Cause Investigation for CAPA

  • Speaker: Vanessa Lopez
  • Product ID: 704409
  • Duration: 60 Min
This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.
CD/Recorded
$299
Recorded/CD
How to Prepare for an FDA Inspection?

How to Prepare for an FDA Inspection?

  • Speaker: Loren Gelber
  • Product ID: 705878
  • Duration: 90 Min
In this FDA inspection webinar attendees will learn the regulatory requirements for all FDA-regulated products. This includes pre-Approval inspection for those products that require a specific submission to FDA, general GMP inspections and for cause inspections, such as those following complaints or recalls. It will also highlight why the prudent firms needs to prepare them self for such inspections.
CD/Recorded
$279
Recorded/CD
FDA's Ambitious Regulation of Social Media

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.
CD/Recorded
$279
Recorded/CD
The Brazilian Pharmacovigilance System

The Brazilian Pharmacovigilance System

  • Speaker: Eliana Silva de Moraes
  • Product ID: 706204
  • Duration: 90 Min
Attend this webinar to learn about the Brazilian pharmacovigilance regulation, risk management, the Health Brazilian Constitution Rights. Learn about labeling, safety reports, harmonization process, benefit-risk legal concept, reciprocity, and more.
CD/Recorded
$299
Recorded/CD
USDA New Proposed Rule on BioEngineered (GMO) Food Disclosure

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.
CD/Recorded
$299
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