Live -Webinar 2014 - Top Selling FDA Webinar Packs

DESCRIPTION
Webinar Packs Includes the recorded access for the below trainings
21CFR 11 Compliance for Excel Spreadsheet
The FDA Inspection: Preparation, Performance, and Followup
U.S. FDA's Strategic Priorities - 2014 and Beyond
Webinar 1 -21CFR 11 Compliance for Excel Spreadsheet - Speaker Angela Bazigos
This course will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.
Why should you attend:
Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimised for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.
Areas Covered in the Session:
1. Requirements for Excel Spreadsheets
2. FDA Part 11 Validation Guidance
3. Compliance Problems with Spreadsheets
4. Design Specifications for 21 CFR 11 compliance
5. How does the FDA Design and Use spreadsheets
6. Documentation for Part 11
7. Future Trends in 21 CFR 11 compliance for Excel Spreadsheets
Who will benefit:
Quality Managers
Quality Engineers
Small business owners
Internal and external auditors
Management Reps
FDA inspectors
Consultants
Webinar 2 - The FDA Inspection: Preparation, Performance, and Followup Speaker Jeff Kasoff
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations! This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.
Areas Covered in the Session
How to prepare for an FDA inspection
Development and contents of an SOP for FDA inspection
Personel training before inspection
How to behave during an inspection
Limitations of scope of inspection
Response to investigation findings
FDA guidance documents used by their inspectors.
Who will benefit: (Titles)
This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
Executive/senior management
Regulatory management
QA management
Any personnel who may have direct interaction with FDA officials
Quality system auditors
Consultants
Webinar 3 - U.S. FDA's Strategic Priorities - 2014 and Beyond Speaker John E. Lincoln
This webinar will examine the U.S. FDA's annual "Strategic Priorities" initiative, with emphasis on 2014 and beyond. It will focus on the broad range of issues a company's senior management and QA/RA staff need to consider in their annual Management Review of their existing quality management system. Such a mandated review is all the more urgent due to the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what the FDA and industry need to do internally. Further evaluation of recent information from the Agency, other goals of the Agency that have already been translated into action in the past year will provide direction in areas of concern and what to expect in the future. This will be performed by a review of applicable FDA "Strategic Priorities" areas for required review or related industry problem areas. Major 510(k) changes will be discussed, as will the new combination products CFRs and pharma requirements.
Areas Covered In the Seminar
The FDA's "Strategic Priorities" for 2014 and Beyond
Mandated Areas for Annual Reviews
Tougher Regulatory Science -- What "Better Science" Really Means
Device, Pharmaceutical and Biological Issues
General CGMP Issues -- Strengthened Compliance
Major / Pending 510(k) Changes
Safety / Integrity of Global Supply Chain
Lifecycle Requirements
Who will benefit
Corporate Management
QA
RA
R&D
Engineering
Production
Marketing