Webinar on Quality System Regulations (QSRs) for Medical Devices and IVDs

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Webinar on Quality System Regulations (QSRs) for
Medical Devices and IVDs
Product Id
MD1351
Category
Medical Devices
Scheduled On
Tuesday, July 1, 2014 at 1300 Hrs
Duration
60 Minutes
Speaker
Dr. David Lim
To register for this webinar please visit
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• Webinar Description

FDA states in warning letters This inspection
revealed that these devices are adulterated
within the meaning of section 510(h) of the FDC
Act, in that the methods used in, or the
facilities or controls used for, their
manufacture, packing, storage, or installation
are not in conformity with the current good
manufacturing practice requirements of the 21 CFR
Part 820. This webinar will address the said
current good manufacturing practice (cGMP)
requirements to help you stay in conformity with
21 CFR Part 820 (QSR). Accurate understanding and
interpretation of cGMP requirements found at 21
CFR Part 820 can significantly contribute to
achieving compliance fast, resulting in saving
significant amount of time and efforts and
bringing innovative medical products to the
market faster. This webinar is intended to help
you get familiar with FDAs Quality System
Regulations (cGMP) for medical devices including
in vitro diagnostic medical devices. This webinar
is further intended to provide guidance on the
best practices for implementing 21 CFR Part 820
(QSRs), which helps assure that medical devices
are safe and effective for their intended
use. This 60-min webinar will help you ensure if
you engage in the best practices for establishing
and maintaining quality management systems
necessary to achieve compliance and to remain
compliant with 21 CFR Part 820 (cGMPs).

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Area Covered In The Session

• Applicable Laws
• FDA Quality System Regulations
• Definitions
• Design Control Design And Development Planning,
  Design Input, Design Output, Design Review,
  Design Verification, Design Validation, Design
  Transfer, And Design Changes
• Design History File (DHF)
• Quality System Procedures, Purchasing Controls
  And Servicing
• Inspection, Measuring And Test Equipment
• Process Validation
• Corrective And Preventive Action (CAPA) And
  Complaint Files
• Quality Requirements For Premarket Approval (PMA)
  Application
• Device History Record (DHR) And Device Master
  Record (DMR)
• Mistakes While Implementing QSRs
• How to Avoid Mistakes
• Frequent Citations in 483s and How to Avoid
• Top 20 Items Cited in 483s

• Who Will Benefit

• CEOs
• VPs
• Compliance Officers
• Attorneys
• RD and Manufacturing Managers
• Managers (RA, QA/QC, CA)
• Consultants
• Contractors and Subcontractors

• Speaker Profile

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is
President and Principal of Regulatory Doctor
(www.RegulatoryDoctor.com). Dr. Lim frequently
presents global regulatory and quality compliance
topics in various forums and meetings. Recently,
Dr. Lim developed 510(k) templates ready for use
compliant with e-Copy and RTA policy. In
addition, Dr. Lim developed FDA inspection
checklists for drug and medical device
manufacturers based on his analysis of FDA
inspectional observations cited in 483s for the
past seven years.
To know more visit https//compliancetrainings.com
/SiteEngine/ProductDetailView.aspx?idMD1351