ComplianceOnline
CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps
19
/ Jun
Wednesday-2019

CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps

  • Speaker: Sunil Gupta
  • Product ID: 704302
  • Duration: 90 Min
This training program will assist anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this training. Effective and practical solutions to address real-world issues will be detailed.
* Per Attendee
$249
Using Kanban JIT Systems to Run a Startup Plant
20
/ Jun
Thursday-2019

Using Kanban JIT Systems to Run a Startup Plant

  • Speaker: Jose Mora
  • Product ID: 700419
  • Duration: 90 Min
Attend this webinar to learn how to set up and use kanbans, JIT, pull system, and drum-buffer-rope in medical device and biotechnology manufacturing start-up operations. Also attendees will learn elements of lean documents and lean configuration, sterilization lot size, MRP II kanban system and how to use kanbans to track off-site sterilization and external supply chain suppliers.
* Per Attendee
$249
FDA's Ambitious Regulation of Social Media
24
/ Jun
Monday-2019

FDA's Ambitious Regulation of Social Media

  • Speaker: Casper Uldriks
  • Product ID: 703853
  • Duration: 60 Min
FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.
* Per Attendee
$229
Streamlining Your Internal Auditing Process
24
/ Jun
Monday-2019

Streamlining Your Internal Auditing Process

  • Speaker: Betty Lane
  • Product ID: 703448
  • Duration: 60 Min
This webinar will cover creating of a value-added internal auditing program that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485. It will include how to set up and manage the auditing system as well as how to conduct an internal audit and document the results and any nonconformities. It will discuss the value of a good internal auditing program.
* Per Attendee
$199
State of the Art: Recommendations for writing a thorough SOA and build SOA Libraries for your CERs
27
/ Jun
Thursday-2019

State of the Art: Recommendations for writing a thorough SOA and build SOA Libraries for your CERs

  • Speaker: Maria Sanchez
  • Product ID: 706081
  • Duration: 90 Min
This webinar will showcase the importance of State of the Art in Clinical Evaluation Reports for Medical Devices and provide tools and recommendations for writing a well-structured SOA setting the stage for the entire CER. The webinar will also provide recommendations to build a State-of-the-Art Library for your medical device portfolio.
* Per Attendee
$249
How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation
28
/ Jun
Friday-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
Quality Management System - Structure and Development
1
/ Jul
Monday-2019

Quality Management System - Structure and Development

  • Speaker: Susanne Manz
  • Product ID: 706098
  • Duration: 90 Min
This webinar will help you to develop a Quality Management System (QMS) for Medical Device Companies. An effective QMS sends a message to the FDA and other regulators that your QMS is complete, accurate, and consistently followed. More importantly, it ensures that your personnel can consistently and accurately meet requirements resulting in correct outcomes and quality work.
* Per Attendee
$249
Implementation and Management of GMP Data Integrity
3
/ Jul
Wednesday-2019

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. Also attendees will examples of data integrity pitfalls, • part 11 compliance data integrity issues, FDA citations related to data integrity and how to improve data integrity in a laboratory environment.
* Per Attendee
$249
Spotlight on Complaint Handling and Medical Device Reporting
9
/ Jul
Tuesday-2019

Spotlight on Complaint Handling and Medical Device Reporting

  • Speaker: Susanne Manz
  • Product ID: 706099
  • Duration: 90 Min
This webinar will help you to understand the expectations of complaint handling and medical device reporting. You’ll also learn about lessons from 483s and warning letters. We’ll discuss how you can develop your processes to efficiently and effectively manage complaints and MDRs. Also, we’ll discuss how to link these processes to failure investigation, recalls, and CAPA (Corrective and Preventive Action). We’ll cover best practices, so you can be prepared for an FDA inspection.
* Per Attendee
$249
The New Usability Engineering Requirements of IEC 62366-1:2015, 2: 2016
9
/ Jul
Tuesday-2019

The New Usability Engineering Requirements of IEC 62366-1:2015, 2: 2016

  • Speaker: John E Lincoln
  • Product ID: 705111
  • Duration: 90 Min
This webinar will focus on the IEC standard and its key requirements: “IEC 62366-1:2015 Part 1: Application of usability engineering to medical devices”. It will touch on “IEC/TR 62366-2:2 Part 2: Guidance on the application of usability engineering to medical devices”. Another webinar will focus on Part 2, and re-evaluate key portions of Part-1.
* Per Attendee
$249
Challenges of an Effective Change Control Program
10
/ Jul
Wednesday-2019

Challenges of an Effective Change Control Program

  • Speaker: Kenneth Christie
  • Product ID: 704638
  • Duration: 90 Min
This training program will provide attendees with a better understanding of current Quality System Regulations (QSR) require companies to maintain qualified equipment, utilities and facilities in a state of control. When changes are made to these items, the change must be documented, explained as to what will be done and the items that may be impacted. This webinar will also highlight what is expected, what to include in procedures and address the challenges faced by industry in trying to establish an effective and manageable program.
* Per Attendee
$249
Root Cause Analysis - Starting at the Beginning
10
/ Jul
Wednesday-2019

Root Cause Analysis - Starting at the Beginning

  • 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.
* Per Attendee
$249
How to Prepare a Standard Operating Procedure (SOP)?
11
/ Jul
Thursday-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
Coatings in Medical Devices – ISO 17327
15
/ Jul
Monday-2019

Coatings in Medical Devices – ISO 17327

  • Speaker: Gary Fischman
  • Product ID: 706059
  • Duration: 60 Min
This webinar provides an understanding of coating systems in general, differences in how coatings are applied, what their weak points might be and how to assess the properties that are appropriate for their needs. The new document ISO 17327 will be discussed and controversies that form from potential use of that document will be assessed.
* Per Attendee
$229
Basics of Testing Associated with Sterilization Validation and Routine Processing
16
/ Jul
Tuesday-2019

Basics of Testing Associated with Sterilization Validation and Routine Processing

  • Speaker: Gerry O Dell
  • Product ID: 701330
  • Duration: 60 Min
This sterilization validation process training webinar will review the FDA or ISO requirements for tests following validation and emphasis is placed on the appropriate tests for validation, the appropriate routine tests and the frequency of testing.
* Per Attendee
$229
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
Supplier Management with the new Medical Device Regulation EU MDR 745/2017

Supplier Management with the new Medical Device Regulation EU MDR 745/2017

  • Speaker: Frank Stein
  • Product ID: 706068
  • Duration: 90 Min
In this webinar, learn how to implement the changes required by the new regulation EU MDR 745/2017 in your current quality management system in a simple and quick way. The information in this course is vital to your passing the Quality Management Audit by your certification company or notified body.
CD/Recorded
$299
Recorded/CD
FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

  • Speaker: Danielle DeLucy
  • Product ID: 704659
  • Duration: 60 Min
The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.
CD/Recorded
$299
Recorded/CD
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs

Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs

  • 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
$249
Recorded/CD
Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements

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

  • Speaker: John E Lincoln
  • Product ID: 700149
  • Duration: 60 Min
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based V&V planning. This webinar will teach you how to develop a master validation plan by evaluating its elements against ISO 14971 hazard analysis / risk management for development of meaningful product validations.
CD/Recorded
$299
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