WEBINARS

 

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

Supplier Quality Agreements - Essential for Suppliers of Many Outsourced Processes

webinar-speaker   Betty Lane

webinar-time   75 Min

Product Id: 702502

This webinar will provide you the information you need to create supplier quality agreements (QA Agreements) with key suppliers and to understand which of your suppliers should have these agreements to meet expectations of the FDA and ISO 13485 Notified Body auditors.

28 / Jul / 2021 - Wednesday

* Per Attendee $199

 

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

webinar-speaker   Ginette M Collazo

webinar-time   60 Min

Product Id: 704210

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.

10 / Aug / 2021 - Tuesday

* Per Attendee $229

 

How to Prepare a Standard Operating Procedure (SOP)?

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705131

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.

Recording Available

* Per Attendee $299

 

CGMP controlled Raw Materials

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 705148

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.

Recording Available

* Per Attendee $399

 

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

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 703875

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.

Recording Available

* Per Attendee $299

 

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

webinar-speaker   Betty Lane

webinar-time   60 Min

Product Id: 702871

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.

Recording Available

* Per Attendee $299

 

Human Error Investigations, Root Cause Determination and CAPA Effectiveness

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 704314

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.

Recording Available

* Per Attendee $299

 

Project Management for FDA-Regulated Companies

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 701758

This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.

Recording Available

* Per Attendee $299

 

QA Agreements for ISO 13485:2019 and other Regulatory Compliance

webinar-speaker   Betty Lane

webinar-time   60 Min

Product Id: 703515

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.

Recording Available

* Per Attendee $249

 

Supplier Management: How to meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner

webinar-speaker   Jeff Kasoff

webinar-time   60 Min

Product Id: 700193

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. The QSR and ISO requirements for supplier assessment will be defined as well. The webinar will discuss the application of a risk-based process resulting in a customized supplier management system.

Recording Available

* Per Attendee $299

 

Medical Devices: EU Directives, CE marking, ISO Certification and the NEW Device Regulations coming to the EU

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 701369

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.

Recording Available

* Per Attendee $299

 

Implementation and Management of GMP Data Integrity

webinar-speaker   Danielle DeLucy

webinar-time   90 Min

Product Id: 705029

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.

Recording Available

* Per Attendee $299

 

How to Investigate Environmental Monitoring Excursions

webinar-speaker   Gerry O Dell

webinar-time   90 Min

Product Id: 701354

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.

Recording Available

* Per Attendee $249

 

Introduction to Root Cause Investigation for CAPA

webinar-speaker   Vanessa Lopez

webinar-time   60 Min

Product Id: 704409

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.

Recording Available

* Per Attendee $299

 

Supplier and Service Provider Controls: FDA Expectations

webinar-speaker   Vanessa Lopez

webinar-time   120 Min

Product Id: 704844

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.

Recording Available

* Per Attendee $349

 

Implementing a Bullet Proof Quality System for FDA Audit Success

webinar-speaker   Meena Chettiar

webinar-time   60 Min

Product Id: 705400

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.

Recording Available

 

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

webinar-speaker   Meena Chettiar

webinar-time   60 Min

Product Id: 705401

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.

Recording Available

* Per Attendee $349

 

Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

webinar-speaker   Vanessa Lopez

webinar-time   90 Min

Product Id: 704758

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.

Recording Available

* Per Attendee $299

 

Understanding FDA Import Alerts: What Are They and Recommendations For Removing Your Company And Products From An Alert

webinar-speaker   Karl M. Nobert

webinar-time   90 Min

Product Id: 703313

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.

Recording Available

* Per Attendee $349

 

Process Validation - Overview of Why and How

webinar-speaker   Betty Lane

webinar-time   60 Min

Product Id: 703520

This webinar will provide understanding of FDA and ISO 13485 requirements for process validation and how to implement them.

Recording Available

* Per Attendee $249

 

 

 

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