ComplianceOnline
CGMP controlled Raw Materials
4
/ May
Tuesday-2021

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.
* Per Attendee
$249
Supplier Management with the new Medical Device Regulation EU MDR 745/2017
5
/ May
Wednesday-2021

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.
* Per Attendee
$249
Medical Device: User Vs Designer - How to Better Recognize and Understand Unmet Needs
7
/ May
Friday-2021

Medical Device: User Vs Designer - How to Better Recognize and Understand Unmet Needs

  • Speaker: Liya Abraha
  • Product ID: 706690
  • Duration: 60 Min
This webinar will cover how medical device designers and manufactures can better understand the unmet needs of their product users to maximize product usage and positive user experience.
* Per Attendee
$199
Quality by Design - Use Design Control to Improve Quality
18
/ May
Tuesday-2021

Quality by Design - Use Design Control to Improve Quality

  • Speaker: Susanne Manz
  • Product ID: 706698
  • Duration: 90 Min
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers. This 90-minute webinar will cover the basics of design controls for medical devices.
* Per Attendee
$249
EU MDR 2017/745 Custom Made Medical Devices
18
/ May
Tuesday-2021

EU MDR 2017/745 Custom Made Medical Devices

  • Speaker: Juan M Campos
  • Product ID: 706696
  • Duration: 60 Min
In this webinar, you will learn how to manage custom-made medical devices according to EU MDR 2017/745 and fully comply with the new EU Medical Device Regulation which is mandatory starting 26-May-2021.
* Per Attendee
$199
Good Documentation Guideline (Chapter <1029> USP)
18
/ May
Tuesday-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
$199
Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017
19
/ May
Wednesday-2021

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 write SOP's that Avoid Human Error
26
/ May
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
Root Cause Analysis - The Heart of Corrective Action
26
/ May
Wednesday-2021

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
Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program
1
/ Jun
Tuesday-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
US FDA Medical Device QSR, 21 CFR 820 and Quality Management System
8
/ Jun
Tuesday-2021

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
$199
How to Prepare a Standard Operating Procedure (SOP)?
15
/ Jun
Tuesday-2021

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
$199
Recorded/CD
Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements

Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements

  • Speaker: John E Lincoln
  • Product ID: 701898
  • Duration: 90 Min
This 90-minute webinar will examine in detail the U.S. FDA and EU MDD requirements for DHFs, DMRs, DHRs, and TF/DDs - their formats, content, and their commonalities, differences, interrelationships, and similarities.
CD/Recorded
$249
Recorded/CD
What Is A Sterilization Dose Audit and How Are They Performed?

What Is A Sterilization Dose Audit and How Are They Performed?

  • Speaker: Martin Byrne
  • Product ID: 706688
  • Duration: 60 Min
The one-hour training discusses the major elements that should be considered prior to, during, and after the performance of a dose audit. The training is designed to instruct attendees on how to critically think about the preparation, performance, reporting, and responding to failures for a dose audit.
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
EU MDR 2017/745 Medical Device Classification

EU MDR 2017/745 Medical Device Classification

  • Speaker: Juan M Campos
  • Product ID: 706685
  • Duration: 60 Min
In this webinar, you will learn how to classify medical devices according to EU MDR 2017/745 Annex VIII for full compliance with new EU Medical Device Regulation mandatory starting 26-May-2021
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
$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
Management Controls Under QSR and ISO 13485

Management Controls Under QSR and ISO 13485

  • Speaker: Jeff Kasoff
  • Product ID: 700988
  • Duration: 60 Min
This session will discuss the requirements for Management Controls, including organizational structure, internal audits, establishment of a quality policy and confirmation it is being followed, establishment and contents of a quality system.
CD/Recorded
$249
Recorded/CD
CAPA is Not a 4 Letter Word: Establishing an Effective and Efficient CAPA Process

CAPA is Not a 4 Letter Word: Establishing an Effective and Efficient CAPA Process

  • Speaker: Susanne Manz
  • Product ID: 706677
  • Duration: 90 Min
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. In these companies, CAPA is a 4 letter word. This webinar will help you avoid identify the symptoms of this common problem. Learn how to avoid those struggles and establish an efficient and effective CAPA process leading to improved quality and compliance for your company. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you.
CD/Recorded
$299
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