Quality System Regulations for Devicemakers: A Regulatory Approach
April 9, 2015 - Fremont CA USCompliance4all
support@compliance4All.com
Phone:8004479407
Fax:302-288-6884
Overview: FDA's findings of the companies Quality System deficiencies fall into a multitude of errors or deficiencies including change control, employee errors, Corrective and Preventive Action (CAPA) and consistent process control as demonstrated through validation and incident tracking systems. The average cost of a Warning Letter remediation effort is estimated at US $750,000 or millions dependent on the product and the identified deficiencies in order to correct the FDA identified deficiencies including added resources for consultants, personnel, remediation of legacy records, etc. The high cost does not necessarily include the ramifications of product recalls or holds, cost of not going into clinical trials or to market with a new product, or delays in FDA 510(k) or PMA (Premarket approval) as a result of a Warning Letter. The cost of FDA non-compliance is therefore WAY more than the cost of compliance which is why Quality Performance is synonymous with PROFITABILITY. Why should you Attend: For the same reason the QSIT (Quality Systems Inspector Training) was originated and is now still being used to make sure we "answer all the potential questions" before an inspector comes in to your facility to determine if you are in compliance with the current regulations Areas Covered in the Session: Multitude of what regulatory agencies are going to review relative to Quality Systems compliance Demonstrate a proactive approach to quality and improve operational efficiency Anticipate and meet FDA expectations for a compliant quality system Incorporate risk-management strategy to quality systems application Build a quality-focused culture and facilitate management support for quality systems processes Track and organize data efficiently to improve the evaluation process Apply effective documentation techniques through the product life-cycle to avoid confusion and manage changes Integrate risk assessment activities into the product design process to meet expectations of "quality by design Identify crucial training issues to address job-specific compliance responsibilities Understand the elements of the and how each subsystem is interconnected to the rest in order to meet GMP requirements Conduct internal audits to monitor quality and apply corrective actions when appropriate Evaluate SOPs, design controls, and validation protocols from a quality perspective and make revisions or improvements as needed Organize and manage evaluation data to improve product quality and address customer complaints Compliance4All Adam Fleaming Phone: +1-800-447-9407 Event Link: http://bit.ly/1N7cJJQ support@compliance4all.com www.compliance4all.com