Online Training 2016 - Best Practices for Compliance with FDA 21CFR1040 - By Compliance Global Inc

Overview
All manufacturers, system integrators and importers of lasers or laser containing products must comply with FDA regulation training 21CFR1040 with very few exceptions. This is accomplished by a self-certification of the device typically using FDA form 3632 Guide for Preparing Product Reports for Lasers or Products Containing Lasers. The completed form and supporting data is then sent to the Center for Devices and Radiological Health ? CDRH training and a document tracking number, commonly known as an accession number, is issued.
This webinar will provide guidance as to the best practices for generating this form 3632 document. It will include recommended methodologies to test and record the emission output and interlock performance of the laser systems. This was derived from many years of experience in the biomedical device field and successfully applying those methodologies to the submission of accession number documents. The resulting documents are generated in a structure familiar to the FDA.
We will also include recommendations for implementing a Quality system, as expected by the FDA, to ensure that subsequent laser systems training of the same model perform to the accepted level of testing as the submitted laser system.
Why Should You Attend
The Center for Devices and Radiological Health (CDRH) does not approve form 3632 reports or the products being reported. “Section 1010.2c requires that certification be based on a test in accordance with the standard and each unit or on a program in accordance with good manufacturing practices. Failure to maintain an adequate testing program may result in disapproval of the program by CDRH.” (form 3632 section 8.2 NOTE).
Certification is the responsibility of the manufacturer, system integrator or importer. However, if the FDA determines that there are deficiencies in the applicant’s quality control or testing program. “CDRH may require the manufacturer to cease introduction into the US until the deficiencies are corrected and to initiate a corrective action program (21CFR1003-1004) for products already introduced into commerce.” (form 3632 Foreword).
The CDRH under the FDA has the ability to impose fines up to $300,000 for non-compliance with 21CFR1040. Recalls for laser products not deemed safe by the FDA can be very disruptive to the manufacturer as well as the end user. In which case, there is the potential for lawsuits by the purchaser or others using the identified non-compliant laser equipment. It is much more cost effective to have an effective Quality system and to perform a robust safety testing prior to shipment rather than as a response to an FDA investigation. These are usually followed by an FDA audited corrective action program.
Areas Covered in this Webinar
Areas to be covered are identifying key components necessary for a robust Quality system, essential supporting documents and structure of the system.
How to develop and document a quality checklist that represents the safety features of the tested system. The key features of a test protocol that will enable repeatability and reproducibility of the safety tests.
Proper collection and documentation of safety test data. The proper evaluation of that data will also be discussed to include analysis of variance that will determine if the results are within acceptable limits.
How to develop and document the test results in a meaningful report with a conclusion statement. We will review how to approach variances from the expected results. These are usually followed by documented corrective actions and retest. All this supports the requirement by the FDA for the system to be built in accordance with good manufacturing practices. The same practices can be leveraged to other production lines to ensure a Quality product is manufactured.
We will review key areas of form 3632. Which areas are non-applicable to your particular laser product and which areas are required. They report type falls into two categories. Either the report is a laser product report or supplemental to and existing accession number. We will discuss when each is applicable and the potential benefits pitfalls of both. The form requires identification of a corresponding official and importing agent. We will review the requirements of each position. We will review common terms used and their specific meaning with respect to form 3632.
A review will also be made of the various laser classifications and the FDA requirements for determining the hazard level that the subject laser is classified. In general the secession should enable a much greater understanding to accession number submittals and their associated Quality requirements.
Learning Objectives
Develop and document a quality checklist that represents the safety features of the tested system
Develop and document the test results in a meaningful report
Learn FDA requirements on GMP training for the tested system
Who Will Benefit
Laser System Manufacturers
Laser Safety Officers
Laser Integrators
Laser Importers
Purchasers of Laser Systems
Engineering Managers
Safety Managers
Contact Officials
Speaker Profile
Tony Imm is a nationally recognized laser engineer with a background in medical device manufacturing. His company, Laser Guardian LLC provides a wide range of laser safety and process support. His experience and training has enabled him to become skilled in implementing laser safety programs and performing supporting audits, primarily for the medical device and pharmaceutical industries. Tony has a recognized development history in micro processing utilizing diode and Nd:YAG lasers.
Tony is experienced in IEC 60825, FDA 21 CFR Part 820, 21 CFR 1040, MIL SPEC 2000 and ISO 2001 controlled processes, validation and documentation. He is a member of American National Standards Institute (ANSI) Z136.1 Safe Use of Lasers and ANSI Z136.9 Safe Use of Lasers in Manufacturing Environments subcommittees. Tony is a member of the International Electrotechnical Commission (IEC), Technical Advisory Group of the TC 76 committee for laser safety standards. IEC is one of the oldest standards making bodies in existence. He is also a Board of Laser Safety, Certified Laser Safety Officer #L3618 and a Certified Six Sigma Black Belt #456774. Laser Guardian is licensed and insured.
For more detail please click on this below link:
https://complianceglobal.us/product/700328/TonyImm...
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