ComplianceOnline

Medical Device Audits and Inspections Training - Live Webinars, Recordings & CDs

ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements?
28
/ Aug
Wednesday-2019

ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements?

  • Speaker: Betty Lane
  • Product ID: 702871
  • Duration: 60 Min
This webinar will benefit medical device companies planning to have a CE mark under the European Union Directive 93/42/EEC. We will discuss what is new in ISO 14971:2012 and help you avoid delays in obtaining or maintaining your CE mark for compliance to the Medical device Directive, EU Directive 93/42/EEC on Medical Devices.
* Per Attendee
$229
Failure Mode Effects Analysis
10
/ Sep
Tuesday-2019

Failure Mode Effects Analysis

  • Speaker: Michael Abitz
  • Product ID: 705333
  • Duration: 60 Min
This webinar will explain how to create Failure Mode Effects Analysis (FMEA) by combining Effective Information Collection (EIC), Process Reliability Modeling (PRM) and Failure Mode Effect Criticality Analysis (FMECA). It will also cover the methods for determining root causes of process problems and effective tools for repair of ineffective processes.
* Per Attendee
$229
Good Documentation Guideline (Chapter <1029> USP)
24
/ Oct
Thursday-2019

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
How to Prepare a Standard Operating Procedure (SOP)?
19
/ Nov
Tuesday-2019

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.
* Per Attendee
$229
Introduction to Root Cause Investigation for CAPA
3
/ Dec
Tuesday-2019

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.
* Per Attendee
$229
4-Hr Virtual Training: How to Respond to an FDA Investigation
4
/ Dec
Wednesday-2019

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
Recorded/CD
CGMP controlled Raw Materials

CGMP controlled Raw Materials

  • Speaker: Charity Ogunsanya
  • Product ID: 705148
  • Duration: 90 Min
This webinar will help the attendee gain an understanding of the appropriate way to design the processing of all cGMP Controlled raw materials that are used for the manufacturing of drug product. The scope of this webinar applies to all cGMP controlled raw materials that are received, requiring testing, release and issuance of specifications. It also applies to the processing of changes and retiring of previously issued controlled raw materials specification within the product manufacturing process. cGMP Raw materials that are used for product manufacturing has to be released for use in the production process. Guidance will be given as to the steps that every drug product manufacturer should follow in order to process all incoming cGMP controlled raw materials which includes the release for use in the manufacturing of products.
CD/Recorded
$299
Recorded/CD
A Bulletproof, Cost-Efficient Supplier Management Program

A Bulletproof, Cost-Efficient Supplier Management Program

  • Speaker: Jeff Kasoff
  • Product ID: 700193
  • Duration: 60 Min
Attend this webinar to learn the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation, including “critical” suppliers and outsourced processes. Also attendees will learn QSR and ISO requirements for supplier assessment and the application of a risk-based process resulting in a customized supplier management system.
CD/Recorded
$299
Recorded/CD
Creating a Risk-based Supplier Management program

Creating a Risk-based Supplier Management program

  • Speaker: Betty Lane
  • Product ID: 702501
  • Duration: 75 Min
This webinar on supplier controls will provide you the information you need to assure your supplier management program is in compliance with the latest FDA, European and international guidelines requiring a risk-based supplier management program. We will look at how to improve your supplier management system to meet both the FDA and ISO expectation while potentially reducing your cost of compliance.
CD/Recorded
$299
Recorded/CD
New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products

New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products

  • Speaker: Angela Bazigos
  • Product ID: 704529
  • Duration: 90 Min
This training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.
CD/Recorded
$249
Recorded/CD
How FDA Trains its Inspectors to Review CAPA, and Best Practices for Inspection Preparation

How FDA Trains its Inspectors to Review CAPA, and Best Practices for Inspection Preparation

  • Speaker: Jeff Kasoff
  • Product ID: 700851
  • Duration: 60 Min
This CAPA investigation training will discuss techniques used by the FDA to review your CAPA system. You will learn what the FDA tells their inspectors to focus in the QSIT document and how your company can use the same QSIT document to prepare for inspection.
CD/Recorded
$249
Recorded/CD
The Most Serious FDA 483s - How to Avoid Them

The Most Serious FDA 483s - How to Avoid Them

  • Speaker: John E Lincoln
  • Product ID: 702766
  • Duration: 90 Min
This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.
CD/Recorded
$299
Recorded/CD
Conducting Effective Quality Audits: Beyond Audit Checklists

Conducting Effective Quality Audits: Beyond Audit Checklists

  • Speaker: Andrew Campbell
  • Product ID: 703539
  • Duration: 60 Min
This webinar will teach attendees best practices for conducting effective quality audits to ensure regulatory compliance. Learn how to avoid potential pitfalls during the audit process.
CD/Recorded
$429
Recorded/CD
Process Verification and Validation Planning and Execution

Process Verification and Validation Planning and Execution

  • Speaker: John E Lincoln
  • Product ID: 701662
  • Duration: 60 Min
This 60-minute session on risk-based verification and validation planning will discuss "must have" elements from the U.S. FDA cGMP, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.
CD/Recorded
$249
Recorded/CD
Supplier Quality Agreements - Required by ISO 13485:2016 for Suppliers of all Outsourced Processes

Supplier Quality Agreements - Required by ISO 13485:2016 for Suppliers of all Outsourced Processes

  • Speaker: Betty Lane
  • Product ID: 703515
  • Duration: 60 Min
In this webinar you will learn how to create detailed quality agreements (QA Agreements) for key suppliers, particularly those for outsourced processes, and to understand which of your suppliers should have these agreements to meet the expectations of the FDA and ISO 13485:2016 and MDSAP. The agreements discussed will meet the expectations of the GHTF and NBOG supplier guidance documents which are now an expectation of both the FDA and most ISO 13485 auditors. These supplier QA agreements can be an important part of demonstrating that you have control of your key suppliers.
CD/Recorded
$249
Recorded/CD
How to undergo an FDA Inspection Successfully

How to undergo an FDA Inspection Successfully

  • Speaker: Marie Morin
  • Product ID: 705170
  • Duration: 90 Min
This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.
CD/Recorded
$249
Recorded/CD
Building a Vendor Qualification Program for FDA Regulated Industries

Building a Vendor Qualification Program for FDA Regulated Industries

  • Speaker: Jonathan M Lewis
  • Product ID: 703467
  • Duration: 60 Min
This webinar will teach attendees best practices for building a sustainable vendor qualification program for FDA regulated industries. It will discuss common pitfalls to avoid when qualifying vendors.
CD/Recorded
$249
Recorded/CD
Computer System Validation and Part 11 Compliance

Computer System Validation and Part 11 Compliance

  • Speaker: Joy McElroy
  • Product ID: 705427
  • Duration: 60 Min
This webinar will discuss in detail the requirements of 21 CFR part 11 and updated European Annex 11 regulation including requirements for local, SaaS, and cloud hosting. It will also offer techniques to implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds.
Recorded/CD
Sampling Plan for Quality Audits

Sampling Plan for Quality Audits

  • Speaker: Daniel O Leary
  • Product ID: 702581
  • Duration: 90 Min
This webinar examines the issues in audit sampling and provides the answers one need to plan audit. It will help attendees understand the use of standard sampling plans in an audit including FDA’s QSIT sampling plans.
CD/Recorded
$229
Recorded/CD
Medical Device Software Verification and Validation

Medical Device Software Verification and Validation

  • Speaker: Nancy Knettell
  • Product ID: 705393
  • Duration: 60 Min
This webinar will teach you how to design, build and test medical device software in preparation for the successful 510k submissions. It will cover medical device software user requirements, software architecture, design, unit testing and more.
CD/Recorded
$249
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