ComplianceOnline

Medical Device Supply Chain and Manufacturing Regulatory Compliance Training - Live Webinars, Recordings & CDs

Medical Devices: EU Directives, CE marking, ISO Certification and the NEW Device Regulations coming to the EU
8
/ Dec
Tuesday-2020

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.
* Per Attendee
$249
Recorded/CD
Implementation and Management of GMP Data Integrity

Implementation and Management of GMP Data Integrity

  • Speaker: Danielle DeLucy
  • Product ID: 705029
  • Duration: 90 Min
Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.
CD/Recorded
$299
Recorded/CD
How to Investigate Environmental Monitoring Excursions

How to Investigate Environmental Monitoring Excursions

  • Speaker: Gerry O Dell
  • Product ID: 701354
  • Duration: 90 Min
This environmental excursion investigation training will review the various items that should be included in the investigation to determine the cause of the limit excursion for both viable and non-viable excursions.
CD/Recorded
$249
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
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
ISO 14971:2019 - Does your Risk Analysis meet this new revision of the Standard?

ISO 14971:2019 - Does your Risk Analysis meet this new revision of the Standard?

  • 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 14971:2019 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.
CD/Recorded
$399
Recorded/CD
Supplier and Service Provider Controls: FDA Expectations

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.
CD/Recorded
$349
Recorded/CD
QA Agreements for ISO 13485:2019 and other Regulatory Compliance

QA Agreements for ISO 13485:2019 and other Regulatory Compliance

  • 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
Implementing a Bullet Proof Quality System for FDA Audit Success

Implementing a Bullet Proof Quality System for FDA Audit Success

  • Speaker: Meena Chettiar
  • Product ID: 705400
  • Duration: 60 Min
This webinar will provide an overview of the FDA expectations in medical device industries for setting up a quality system for FDA audit readiness. It will also provide an understanding of the quality system inspection techniques (QSIT) requirements for documents controls, production and process controls, packaging and labeling controls and more.
Recorded/CD
Understanding Key Quality System Requirements for Combination Product (Medical device and Pharmaceuticals) Manufacturers

Understanding Key Quality System Requirements for Combination Product (Medical device and Pharmaceuticals) Manufacturers

  • Speaker: Meena Chettiar
  • Product ID: 705401
  • Duration: 60 Min
This webinar will explain the quality system regulations (QSR) for combination device manufacturers to ensure compliance with for FDA and ISO 13485 requirements. It will also provide practical tips to sustain the growth of your quality system in the long run.
CD/Recorded
$349
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
$399
Recorded/CD
Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

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.
CD/Recorded
$299
Recorded/CD
Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

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.
CD/Recorded
$299
Recorded/CD
Understanding FDA Import Alerts:  What Are They and Recommendations For Removing Your Company And Products From An Alert

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.
CD/Recorded
$349
Recorded/CD
Process Validation - Overview of Why and How

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.
CD/Recorded
$249
Recorded/CD
Making Data Driven Decisions using Statistical Hypothesis Testing

Making Data Driven Decisions using Statistical Hypothesis Testing

  • Speaker: Steven Wachs
  • Product ID: 704211
  • Duration: 60 Min
This training program will cover statistical hypothesis testing concepts including: null and alternate hypotheses, test statistics, p-values, confidence intervals, confidence levels, power, power curves, and sample sizes. Several types of hypothesis tests will be covered such as 1 and 2-sample means tests, tests of variances, and tests of proportions. Equivalence tests will also be discussed. The importance of selecting appropriate sample sizes will be stressed.
CD/Recorded
$299
Recorded/CD
How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

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.
CD/Recorded
$299
Recorded/CD
Human Error Investigations, Root Cause Determination and CAPA Effectiveness

Human Error Investigations, Root Cause Determination and CAPA Effectiveness

  • Speaker: Ginette M Collazo
  • Product ID: 704314
  • Duration: 90 Min
This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.
CD/Recorded
$299
Recorded/CD
Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes

Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes

  • Speaker: Charity Ogunsanya
  • Product ID: 703885
  • Duration: 90 Min
This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.
CD/Recorded
$299
Recorded/CD
Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

  • Speaker: Robert J Russell
  • Product ID: 705370
  • Duration: 90 Min
This webinar will focus on the key regulatory requirements for medical devices for the participating MDSAP countries of U.S., Canada, Brazil, Australia and Japan. It will address key topics such as device classification, licensing pathways, medical device GMP, inspections, device labeling, license holder responsibilities and more.
CD/Recorded
$299
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