ComplianceOnline
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
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
Writing and Revising SOPs for Increased Operational Efficiency
16
/ Jan
Thursday-2020

Writing and Revising SOPs for Increased Operational Efficiency

  • Speaker: Rob MacCuspie
  • Product ID: 706214
  • Duration: 60 Min
This webinar will discuss how to more effectively write and revise standard operating procedures (SOPs) with a focus on increasing operational efficiencies.
* Per Attendee
$229
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
Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements
22
/ Jan
Wednesday-2020

Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements

  • Speaker: John E Lincoln
  • Product ID: 700149
  • Duration: 60 Min
In this webinar attendees will learn both the U.S. FDA and EU's MDD/MDR expect documented risk-based "master" and "individual" V&V planning. Various validation terms are explained with useable “working” definitions. The Validation Master Plan, and suggested field-tested individual V&V plans, Test Report / Protocol formats, and individual test cases, IQ, OQ, and PQs, are presented.
* 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
Developing a Strategic Approach to FDA Compliance for Computer Systems
29
/ Jan
Wednesday-2020

Developing a Strategic Approach to FDA Compliance for Computer Systems

  • Speaker: Carolyn Troiano
  • Product ID: 706124
  • Duration: 90 Min
This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations, which is critical in order to be able to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. We will discuss the phases within the SDLC, and how these form the basis for any CSV project that you may undertake, and the importance of the sequence of steps will also be covered, to ensure you are able to comply with FDA expectations.
* Per Attendee
$249
Occupational Safety of Nanomaterials
11
/ Feb
Tuesday-2020

Occupational Safety of Nanomaterials

  • Speaker: Rob MacCuspie
  • Product ID: 706203
  • Duration: 60 Min
This webinar will discuss how to use tiered approaches to evaluate the occupational safety risks of nanomaterials handling and processing for both laboratory environments and production environments, as well as common risk mitigation approaches.
* Per Attendee
$229
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
12
/ Feb
Wednesday-2020

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

  • Speaker: David Nettleton
  • Product ID: 701687
  • Duration: 90 Min
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
* Per Attendee
$249
Comparison Between the EU and FDA Regulatory Protocols
12
/ Feb
Wednesday-2020

Comparison Between the EU and FDA Regulatory Protocols

  • Speaker: George Yanulis
  • Product ID: 706297
  • Duration: 90 Min
This webinar compares the EU and FDA regulatory protocols to help individuals involved in manufacturing, customer service, quality assurance roles to streamline their understanding of the rapid and ongoing regulatory changes being adopted by all medical device regulatory bodies where manufacturers sell and manufacture their devices.
* Per Attendee
$249
Recorded/CD
Drug Manufacturing Inspection Part III

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.
Recorded/CD
FDA: Mock and Pre-Approval Inspections (PAIs) - Part II

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).
Recorded/CD
Preparing for and Responding Effectively In a Positive Manner to an FDA Postmarket Surveillance Visit

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.
Recorded/CD
Good Documentation Practice (GDocP) for FDA Regulated Industry

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.
CD/Recorded
$249
Recorded/CD
FDA Inspections: Understanding the Core Elements – Part I

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.
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