Data Management SOPs
Adam Ruskin
60 Min
Product Id: 703376
This webinar will teach attendees how to develop more efficient data management SOPs for their company, whether they perform these tasks in-house, oversee this task that a vendor provides, or outsource this task in its entirety.
Equipment Requalification: What and When it is Really Required?
Jennifer Medlar
60 Min
Product Id: 703450
This webinar will explain how to generate a practical and compliant methodology to handle equipment requalification. Attendees will learn about common pitfalls to avoid when requalifying equipment.
Regulatory Records Primer: Decoding the Requirements for Medical Device and Pharmaceutical Manufacturers
Les Schnoll
90 Min
Product Id: 703433
This webinar will explain FDA regulatory records requirements for medical devices and finished pharmaceuticals. It will cover statutory requirement, required content, format, purpose, retention, and structure for regulatory records for both medical devices and pharmaceuticals.
Quality Systems Approach for Validation and Maintenance of a Global ERP System
James Carron
90 Min
Product Id: 703424
This webinar will explain how to implement an Enterprise Resource Planning (ERP) system by integrating a company’s existing quality system. It will cover selection, analysis, initiation, design, validation and test phases, including change control.
Adverse Event Reporting Requirements for Dietary Supplements and OTC Drugs
Mukesh Kumar
90 Min
Product Id: 703422
This webinar will discuss regulatory requirements for adverse event reporting for dietary supplements and OTC products. It will explain the similarities and differences in reporting adverse events for dietary supplements and OTC products and will also discuss trends in FDA audit for these products.
LDT including CDx; CLIA versus FDA's Authority
Abdel Halim
60 Min
Product Id: 703399
This webinar will explain the regulatory path of an in vitro diagnostic (IVD) and Laboratory Developed Test (LDT). It will discuss the CLIA regulations for Laboratory Developed Tests (LDTs), including companion diagnostics (CDx) and how these differ from the FDA’s authority.
How to respond to GXP (GCP, GLP, GMP, GPV) Inspection and Audit Findings using Correction and Preventative Action (CAPA)
Laura Brown
60 Min
Product Id: 703160
This webinar will help attendees understand how to respond to inspection and audit findings using CAPA (Correction and Preventative Action) for all types of GXP inspections and audit (eg GCP, GLP, GMP, GPV).
Medical Device Excise Tax
Daniel O Leary
90 Min
Product Id: 703114
This webinar explains the excise tax on medical device manufactures that went into effect on January 1, 2013, including the devices it covers and the effective selling price for tax purposes.
Overview of the Medical Device Risk Management Standard-ISO 14971
Edwin L Bills
90 Min
Product Id: 700524
This medical device risk management webinar will provide attendees an overview of ISO 14971requirements and practical tips for implementing an effective system for managing risk. It will also discuss differences between the world-wide international standard ISO 14971:2007 and the Europe-only version risk management standard EN ISO 14971:2012.
CMC Considerations for INDs and NDAs for 505(b)(2) Products
Mukesh Kumar
90 Min
Product Id: 703393
This webinar will highlight the key elements of the Chemistry, Manufacturing and Controls (CMC) section of an IND and NDA application for a 505(b)(2) product using examples and case studies. It will also discuss role of Drug Master Files (DMFs), and cross reference authorizations.
CFR 21 Part 11 and Annex 11: How to Avoid the Audit Traps
Chinmoy Roy
75 Min
Product Id: 702279
This webinar on Part 11/Annex 11 audit and enforcement will explain what the auditors are trained to look for during a Part 11/Annex 11 “tag along” audit. It will cover inspection trends with examples of some recent 483s and warning letters and show what one need to do to have a successful inspection outcome.
Overview of Importing Foreign Cosmetic and OTC Products
Marc Sanchez
60 Min
Product Id: 703379
This webinar will cover key definitions like cosmetics, new drugs, adulteration and misbranding, including key concepts like color additive restrictions and labeling requirements. Attendees will learn best practices for responding to Warning Letters.
Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements
Jeff Kasoff
60 Min
Product Id: 700254
This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control.
FDA Regulatory Actions: It's Not Just about Warning Letters
Fredric Richman
60 Min
Product Id: 703344
This training will outline the possible consequences for failing to promptly and adequately correct significant violations related to cGMPs, new drugs or devices, labeling or other regulatory issues resulting in advisory, administrative and judicial actions.
FDA Premarket Review of New and Modified Tobacco Products
Azim Chowdhury
60 Min
Product Id: 703127
This training on FDA regulatory requirements for tobacco products will focus on the premarket review of new and modified tobacco products. It will also discuss the impact of FDA deeming regulation for of e- cigarettes and novel tobacco products on premarket authorization requirements.
How to file a 510(k) when your device is (or contains) software
Cheryl Wagoner
75 Min
Product Id: 703366
The Webinar will discuss the structure and level of detail required in filing a 510(k) when a medical device is software or contains software.
Understanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries
John Chapman
60 Min
Product Id: 701003
This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. ISO 13485:2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485:2003 will find themselves very closely compliant with FDA’s Quality System Requirements under 21CFR 820. This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements.
Managing the Trial Master File - Considerations for Moving to Electronic TMFs
Eldin Rammell
60 Min
Product Id: 703256
This clinical compliance training will review what issues one needs to consider if one’s organization is thinking about introducing an IT solution for the management of trial master file content. Attendees will gain an understanding of how to comply with the regulatory requirements that are pertinent to the maintenance of the TMF and how to choose efficient supporting TMF processes.
Mobile Medical Applications: Software Regulatory Requirements
Tim Stein
90 Min
Product Id: 702812
This mobile medical apps training will outline the regulatory requirements for medical device software development processes, and the requirements for submissions.
Supplier Quality Management: Implement it Now or Pay for it Later
Les Schnoll
90 Min
Product Id: 703357
This webinar will discuss FDA's requirements for medical device supplier management and the controls you need to have in place to ensure compliance with quality. It will cover how to structure a supplier quality agreement and the tools and methods you need for evaluating and assessing suppliers.