ComplianceOnline
Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements
1
/ Dec
Tuesday-2020

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

  • Speaker: John E Lincoln
  • Product ID: 700149
  • Duration: 60 Min
In this webinar attendees will learn both the U.S. FDA and EU's MDD/MDR expect documented risk-based "master" and "individual" V&V planning. Various validation terms are explained with useable “working” definitions. The Validation Master Plan, and suggested field-tested individual V&V plans, Test Report / Protocol formats, and individual test cases, IQ, OQ, and PQs, are presented.
* Per Attendee
$229
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
FDA's Ambitious Regulation of Social Media
10
/ Dec
Thursday-2020

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
Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017
14
/ Dec
Monday-2020

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
How To Establish an Effective Chief Compliance Officer's (CCO) or Chief Risk Officer's (CRO) Function - Organization and Responsibilities
15
/ Dec
Tuesday-2020

How To Establish an Effective Chief Compliance Officer's (CCO) or Chief Risk Officer's (CRO) Function - Organization and Responsibilities

  • Speaker: Javier Kuong
  • Product ID: 700095
  • Duration: 120 Min
This training will provide valuable knowledge on what companies need to do to establish an "effective" Compliance Office that leads to conceiving, developing and implementing successful GRC programs and provides top level coordinating leadership for governance, risk management and compliance issues across the enterprise.
* Per Attendee
$199
Medical Device Cybersecurity Risk Management Training
21
/ Dec
Monday-2020

Medical Device Cybersecurity Risk Management Training

  • Speaker: Frank Stein
  • Product ID: 706560
  • Duration: 3 hrs
This webinar will give you a clear structured overview and introduction, into the cybersecurity risk management in relation to the cybersecurity regulation in EU and US and its requirements in the EU and US.
* Per Attendee
$329
Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program
11
/ Jan
Monday-2021

Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

  • Speaker: Frank Stein
  • Product ID: 706565
  • Duration: 4 Hrs
This course will give an introduction into the Medical Device Single Audit Program (MDSAP) and how to adjust your internal audit program. The introduction will give an overview about the requirements for the quality management system and how to conduct an internal audit with MDSAP requirements to check, if your quality management system meet all MDSAP requirements.
* Per Attendee
$429
How to write SOP's that Avoid Human Error
27
/ Jan
Wednesday-2021

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.
* Per Attendee
$249
Good Documentation Guideline (Chapter <1029> USP)
10
/ Feb
Wednesday-2021

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
Recorded/CD
ISO 14971 Medical Device Risk Management Training

ISO 14971 Medical Device Risk Management Training

  • Speaker: Frank Stein
  • Product ID: 706564
  • Duration: 3 hrs
This course will give an introduction into the new ISO 14971:2019 and how to create a risk management file according the ISO 14971:2019. It will give you an overview about the requirements the interfaces to Post-Market-Surveillance, Clinical Evaluation, Bench-Testing and Life-Cycle-Management. and how a smart implementation of these requirements in your product documentation is possible and finally what are the expectations of the European Notified Bodies.
CD/Recorded
$499
Recorded/CD
Validation Sampling Plans

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.
CD/Recorded
$299
Recorded/CD
Veterinary Medical Devices and FDA’s Regulatory Oversight

Veterinary Medical Devices and FDA’s Regulatory Oversight

  • Speaker: Karl M. Nobert
  • Product ID: 703769
  • Duration: 60 Min
This webinar will make your understand regulatory requirements of veterinary medical device. How to differentiate regulations of human and veterinary medical devices, manufacturing requirements, safety standards, labelling requirements, how to draft the SOPs covering material intake, production, quality control, packing, distribution and sales.
CD/Recorded
$399
Recorded/CD
Attaining Your CE Mark for Your Medical Device in the EU

Attaining Your CE Mark for Your Medical Device in the EU

  • Speaker: Charles H Paul
  • Product ID: 706543
  • Duration: 60 Min
The letters ‘CE’ appear on many products that are traded on the single market in the European Economic Area (EEA). By placing the CE mark on a product, a manufacturer is declaring, on his sole responsibility, conformity with all of the legal requirements necessary to achieve CE marking status. With that mark, the manufacturer is ensuring validity for that product to be sold throughout the EEA. CE marking does not mean that a product was made in the EEA, but states that the product is assessed before being placed on the market. It means the product satisfies the legislative requirements to be sold there.
CD/Recorded
$399
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
Streamlining your QMS and Audit System for Remote Audits

Streamlining your QMS and Audit System for Remote Audits

  • 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.
CD/Recorded
$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
FDA Inspections: Anticipation, Preparation, Reaction, Conclusion…Repeat

FDA Inspections: Anticipation, Preparation, Reaction, Conclusion…Repeat

  • Speaker: John Misock
  • Product ID: 706557
  • Duration: 120 Min
FDA regulated industries can prophet by understanding the regulatory power of FDA and incorporating this knowledge into their daily routine. Time and resources spent preparing for the inevitable inspection will pay back proportionately. By doing your homework and putting simple principles to work you can minimize the negative effects of FDA’s power and put everyone in your organization at ease. By understanding the risks inherent in your products, you can develop a quality system that will align your operation with FDA’s expectations. Why live in fear when you can rest at night knowing you are ready?
CD/Recorded
$449
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
Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP

Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP

  • Speaker: John E Lincoln
  • Product ID: 700817
  • Duration: 60 Min
This webinar will discuss the basic principles of P&PC, specifically as required by the FDA. Also attendees will learn the ISO 13485 and risk analysis / management requirements to evaluate the chief areas of an FDA CGMP compliance inspection / audit to locate areas for implementation and improvement in P&PC.
CD/Recorded
$399
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