ComplianceOnline
Managing Non-conforming Material and Failure Investigations
23
/ Oct
Wednesday-2019

Managing Non-conforming Material and Failure Investigations

  • Speaker: Susanne Manz
  • Product ID: 706245
  • Duration: 90 Min
Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material. You’ll learn how to identify, segregate, control, and disposition non-conforming material. You’ll learn about when and how to conduct failure investigations and requirements for correction and corrective action.
* Per Attendee
$249
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
US FDA Medical Device QSR, 21 CFR 820 and Quality Management System
29
/ Oct
Tuesday-2019

US FDA Medical Device QSR, 21 CFR 820 and Quality Management System

  • Speaker: John E Lincoln
  • Product ID: 705794
  • Duration: 60 Min
Learn the basic overview of the original medical device Quality Management System -- The US FDA’s CGMP, Quality System Regulation (QSR) under 21 CFR 820. Implementation, training requirements and content, and annual internal audit / inspection expectations. The FDA’s four key areas of compliance under QSIT.
* Per Attendee
$229
EU IVDR 2017/746 - the new EU regulation for invitro diagnostic
31
/ Oct
Thursday-2019

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
Reduce Compliance and Recordkeeping Burdens
4
/ Nov
Monday-2019

Reduce Compliance and Recordkeeping Burdens

  • Speaker: Susanne Manz
  • Product ID: 706248
  • Duration: 90 Min
This webinar will cover strategies to improve the efficiency of your Quality Management System (QMS) for medical device companies. It will get you started in setting up a quality system that reduces compliance burden. We’ll. discuss techniques for improving efficiency, reducing burden, and still maintain an effective QMS.
* Per Attendee
$199
Powerful Closed-loop CAPA - Meeting FDA Expectations
6
/ Nov
Wednesday-2019

Powerful Closed-loop CAPA - Meeting FDA Expectations

  • Speaker: John E Lincoln
  • Product ID: 702012
  • Duration: 90 Min
This 90-minute webinar will show how you can implement a closed-loop CAPA system that meets CGMP requirements and U.S. FDA expectations. You will learn simple, but powerful, tools and methods that you can use regularly and systematically to define and resolve root causes, not just symptoms.
* Per Attendee
$249
Human Error and Cognitive Load: How to Reduce Memory and Attention Failures
12
/ Nov
Tuesday-2019

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
Introduction to SPC (Statistical Process Control)
14
/ Nov
Thursday-2019

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
Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities
19
/ Nov
Tuesday-2019

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
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
You have a BI Positive or Product Sterility Positive - Now What?
19
/ Nov
Tuesday-2019

You have a BI Positive or Product Sterility Positive - Now What?

  • Speaker: Gerry O Dell
  • Product ID: 703288
  • Duration: 60 Min
This webinar will discuss what actions should be taken following a positive result in a sterility test on a biological indicator (BI) during performance qualification or routine testing. It will also explain the various items that should be investigated to determine the root cause and the follow up to the investigation.
* Per Attendee
$229
Changes in the upcoming Standard ISO 14971:2019
22
/ Nov
Friday-2019

Changes in the upcoming Standard ISO 14971:2019

  • Speaker: Bijan Elahi
  • Product ID: 706257
  • Duration: 60 Min
The third revision of ISO 14971 will be released in Q4, 2019. Upon release it will cancel and replace ISO 14971:2007. In this webinar you will learn what has changed and how to prepare for compliance to the new Standard.
* Per Attendee
$229
How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation
25
/ Nov
Monday-2019

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

  • Speaker: Charity Ogunsanya
  • Product ID: 703875
  • Duration: 90 Min
This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes.
* Per Attendee
$249
Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017
26
/ Nov
Tuesday-2019

Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017

  • Speaker: Frank Stein
  • Product ID: 706121
  • Duration: 90 Min
This webinar will help you understand the requirements of the new medical device regulation EU MDR 745/2017 and teach you how to create the reports. The understanding of the changes and how to implement last-minute changes until May 2020 is essential to keep your certificates and to sell your products after May 2020 to the European Union.
* Per Attendee
$249
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
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
Managing Multi Track Audits

Managing Multi Track Audits

  • Speaker: Deb Simpson
  • Product ID: 706206
  • Duration: 90 Min
This course will prepare you to manage multiple auditors and audit teams for audits with multiple evaluation paths (tracks). This includes How to prepare your Audit Leaders and Subject Matter Experts (SME), How to prepare your Back Room (Work Room) staff, How to prepare a comprehensive schedule to ensure the right people are in the right place at the right time during the audit. Although this course is focused on multiple track audits for the Medical Device or Life Sciences industry, the process and tools defined in this course can be applied to any audit.
Recorded/CD
Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)

Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)

  • Speaker: Steven Wachs
  • Product ID: 705020
  • Duration: 90 Min
This webinar discusses methods for estimating process capability for both normal and non-normal data. Methods include estimating the proportion of defective products that may be produced as well as the calculation and use of common process capability indices (e.g. Cpk and Ppk). Process Capability assessments are discussed in the overall context of quality improvement/management.
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
Recorded/CD
Metrology - Statistical Analysis of Measurement Uncertainty

Metrology - Statistical Analysis of Measurement Uncertainty

  • Speaker: John N Zorich
  • Product ID: 706202
  • Duration: 90 Min
Attend this webinar to learn about the fundamental vocabulary and concepts related to metrology including accuracy, precision, calibration, and "uncertainty ratios". Several of the standard methods for analyzing measurement variation including Gage R&R, Gage Correlation, Gage Linearity, and Gage Bias described and explained. You will learn how to combine all relevant uncertainty information into an "Uncertainty Budget" to determine the appropriate width of QC specification intervals (i.e., "guard-banded specifications").
CD/Recorded
$299
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