ComplianceOnline
Process Validation - Overview of Why and How
7
/ Apr
Tuesday-2020

Process Validation - Overview of Why and How

  • Speaker: Betty Lane
  • Product ID: 703520
  • Duration: 60 Min
This webinar will provide understanding of FDA and ISO 13485 requirements for process validation and how to implement them.
* Per Attendee
$199
Introduction to SPC (Statistical Process Control)
8
/ Apr
Wednesday-2020

Introduction to SPC (Statistical Process Control)

  • Speaker: John N Zorich
  • Product ID: 706230
  • Duration: 90 Min
Attend this webinar to learn how to use SPC to meet ISO requirements for "continual improvement" as well as FDA requirements to "control and monitor production processes". It introduces SPC, using Xbar-R charts as an example.
* 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
EU IVDR 2017/746 - the new EU regulation for invitro diagnostic
21
/ Apr
Tuesday-2020

EU IVDR 2017/746 - the new EU regulation for invitro diagnostic

  • Speaker: Frank Stein
  • Product ID: 706170
  • Duration: 90 Min
Attend this webinar to understand the new requirements of the medical devices regulation EU IVDR 2017/746 in the European Union and get ready to receive the new certificates until May 2022.
* Per Attendee
$249
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
22
/ Apr
Wednesday-2020

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

  • Speaker: Jose Mora
  • Product ID: 705692
  • Duration: 90 Min
* Per Attendee
$199
Designing Medical Devices for Safety with High Return on Investment
23
/ Apr
Thursday-2020

Designing Medical Devices for Safety with High Return on Investment

  • Speaker: Dev Raheja
  • Product ID: 706271
  • Duration: 60 Min
This webinar will cover the new paradigms for designing safe products. It will discuss how to plan for Zero Defects at little or no cost resulting in high return on investment. It will cover real industry examples from the instructor’s experience.
* 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
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
Understanding FDA Design Verification and Validation Requirements for Medical Devices
27
/ Apr
Monday-2020

Understanding FDA Design Verification and Validation Requirements for Medical Devices

  • Speaker: Meena Chettiar
  • Product ID: 705331
  • Duration: 75 Min
This webinar will help you understand specific product verification and validation requirements for medical devices to comply with ISO 13485: 2016 and FDA quality system regulations. It will focus on the topics such as product development process, traceability and risk management at all stages, design outputs and documentation in DMR and DHR, design verification and design validation activity cycles and more.
* Per Attendee
$229
Internal Audit For Medical Device Companies - How To Make Your Audit Program More Effective
27
/ Apr
Monday-2020

Internal Audit For Medical Device Companies - How To Make Your Audit Program More Effective

  • Speaker: Susanne Manz
  • Product ID: 706445
  • Duration: 90 Min
Internal audit should be an essential guide to corrective and preventive action and drive improvement. But it doesn’t always work that way. In this webinar, we’ll cover the reasons internal audit doesn’t work and how you can correct that. This webinar will explore how to improve your internal audit program so it is the efficient and effective tool it is meant to be. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance and quality risks. A well-designed audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk.
* Per Attendee
$249
Validation Sampling Plans
28
/ Apr
Tuesday-2020

Validation Sampling Plans

  • Speaker: Alan M Golden
  • Product ID: 706332
  • Duration: 60 Min
This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation will also be presented.
* Per Attendee
$229
Hazard Analysis and Risk Management under ISO 14971:2007/2012
28
/ Apr
Tuesday-2020

Hazard Analysis and Risk Management under ISO 14971:2007/2012

  • Speaker: John E Lincoln
  • Product ID: 701693
  • Duration: 60 Min
In this webinar attendees will learn how to develop, use and document Hazard Analysis and the Product Risk Management File and Report per ISO 14971:2007/12 and ICH Q9. Also a field-tested (US FDA and EU Notified Body) multi-industry “model” will be presented in detail.
* Per Attendee
$229
Understanding, Calculating, and Using Statistical Power in Sample Size Determinations for Significance Tests
29
/ Apr
Wednesday-2020

Understanding, Calculating, and Using Statistical Power in Sample Size Determinations for Significance Tests

  • Speaker: John N Zorich
  • Product ID: 706176
  • Duration: 90 Min
Calculation of power is so complicated that it typically must be done with a software program. Even so, the software program's output can be misunderstood unless the user has a firm understanding of the basic concept of statistical power. This seminar helps the attendee to understand and use the output of power calculations, to determine adequate sample sizes and to determine whether or not a product or process meets requirements.
* Per Attendee
$249
Webinar on Medical Device Regulatory intelligence
1
/ May
Friday-2020

Webinar on Medical Device Regulatory intelligence

  • Speaker: James W Monroe
  • Product ID: 706457
  • Duration: 60 Min
This webinar will demonstrate methodologies for obtaining competitor information to use for the establishment of equivalence. You will also learn how to monitor changes in the global regulatory medical device landscape.
* Per Attendee
$229
Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities
6
/ May
Wednesday-2020

Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

  • Speaker: Vanessa Lopez
  • Product ID: 704758
  • Duration: 90 Min
This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.
* Per Attendee
$249
Recorded/CD
Root Cause Analysis - Getting to the Bottom of It

Root Cause Analysis - Getting to the Bottom of It

  • Speaker: John E Lincoln
  • Product ID: 701373
  • Duration: 90 Min
This failure investigation and root cause analysis training will present a repeatable methodology / defined systems, and simple tools that you can use to trace problems to their source and root cause. Attendees will get knowledge on Flow charts, Cause and Effect Diagrams, the 5 Whys, and other statistical tools to accomplish FI/RCA.
CD/Recorded
$299
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
Medical Devices: EU Directives, CE marking, ISO Certification and the NEW Device Regulations coming to the EU

Medical Devices: EU Directives, CE marking, ISO Certification and the NEW Device Regulations coming to the EU

  • Speaker: Robert J Russell
  • Product ID: 701369
  • Duration: 90 Min
This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.
CD/Recorded
$299
Recorded/CD
How to write SOP's that Avoid Human Error

How to write SOP's that Avoid Human Error

  • Speaker: Ginette M Collazo
  • Product ID: 704418
  • Duration: 90 Min
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
CD/Recorded
$299
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