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Overview: Primary Student Objectives - General High Level Topics where we will move down to very specific discussion and details to generate a much higher comprehension for quality individuals even though during this course you will not have to take a final exam! Upon completing this course participants will gain a much better Quality Systems comprehension, based on the instructor's decades of experience helping generate quality system regulations, working with the FDA, fixing FDA findings and generating a synergistic discussion with the attendees to help us all make sure we understand that there is rarely ever on "one" way to do things or "right and wrong", just like making an assumption about the Root Cause of an incident rather than working together to realize there are other things that took place that the individual making the assumption may not have been aware of. 1. What is expected from the QA professional and how other industries (FAA, ISO, EPA, etc.) have made Quality Systems so profitable by having the Head of Operations and the Head of Quality trading places every 6 months. 2. Gaining a more practical Comprehension from experience of the Quality Systems regulations not just reading and thinking you are an expert (reading three books on how to ride a bicycle does not make you an expert). 3. Once we have a better perspective then we will identify the necessary activities like working on a thesis to generate the needed performance for the entire Quality System. 4. How to apply current technology to generate the objective evidence needed to generate the attitude of making the FDA successful when inspecting by answering all the potential inspector questions before asked. Use the applicable technology to think like an FDA inspector 5. How are we going to maintain documented evidence to prove that the process and initial validation is still working in accordance with the Quality System regulations 6. Make sure we have the proper tools and comprehension to perform the needed internal audits which ensures that when a client audits the company or the FDA inspects the facility, we have already been doing all the things they might be reviewing. 7. Making sure that all the laboratory, inspection, calibration, and related quality verification activities are working in a way that generates higher profitability by generating continuous quality improvement (CQI) 8. Ensuring that vendors are practicing the similar quality performance to make sure we don't get hit by their lack of consistency and quality performance based on the needed specifications for our process or products. 9. Defining the expected although not actually defined by the FDA what we need to demonstrate GDP (good documentation practices) which also serve as "legal" documents if something negative happens. 10. Management of Incidents, Deviations, Changes - Incident tracking systems(ITS), deviation management (OOS, OOT, OOL, etc), Critical Change Control (CCR) and Corrections, Corrective Action and Preventative Action (CAPA). 11. Batch Production Record (BPR) or Device History Record (DHR) related to the master versions of the documents used for production and the review before release. 12. How to use statistics for Quality Systems and make sure that 6 Sigma is not being used during the validation activities. Who will benefit: • Senior quality managers • Quality professionals • Regulatory professionals • Compliance professionals • Production supervisors • New FDA Inspectors • Manufacturing engineers • Production engineers • Design engineers • Process owners • Quality engineers • Quality auditors • Document control specialists • Record retention specialists • Marketing and Medical Affairs • Legal Professionals Course Outline: Day One Lecture 1: Job Functions Lecture 2: Quality Systems Lecture 3: Quality Compliance Lecture 4: Method Development and related activities associated with Technology Transfer - Quality Testing as well as Production Lecture 5: Validation, Verification and on-going Cost Savings programs to generate Continuous Quality Improvement Lecture 6: How to ensure an inspector is impressed while doing his/her inspection based on what the instructor helped with generating the quality systems inspector training - each student will get a copy of the workbook to be able to get their company in quick compliance. Day 2 – Agenda Lecture 7: Continued portion of 6 to ensure Quality Assessments are occurring in compliance with QSIT (statistics, incident tracking, 6 Sigma, audits, lab tests, inspections, document control, etc.) Lecture 8: Quality Agreement regulatory requirements and vendor inspections Lecture 9: Ensuring that all the above topics generate the proper "legal documents" that must be in compliance with the company's specific GDP requirements Lecture 10: Ensuring that the Incident Tracking System and Customer Complaints are being properly managed to minimize patient risk (CAPA and Change Control Management, etc.) Lecture 11: Regulatory requirements for setting up Procedures and BPRs / DHRs including the Master Records to make sure we are minimizing operator error and making the Document Review process more effective and cheaper prior to Product Release Lecture 12: Using all the above to make adjustments to the company's regulatory submissions and the related DMF when applicable. ABOUT SPEAKER – Mr. Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US. He has worked with or assisted more than two dozen companies with the establishment of controlled document/quality systems, FDA briefing and submittal documents, project management of several multimillion dollar projects including design, start-up and validation to assure fast track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation, and has written numerous submission documents for product, process and facility approval/licensing which also required the development of quality systems which included customer complaint management, deviation management, CAPA and associated site wide employee training. Each of his projects have been received and accepted by the FDA and other regulatory agencies. Jerry is considered and expert in most all aspects of the biopharmaceutical and medical device industry and has trained many FDA field inspectors on a variety of topics. None of his work has ever received a 483 but has corrected and prevented many along with Warning Letter remediation. Location: San Diego, CA September 25th & 26th, 2014 9:00 AM to 6:00 PM Venue: WILL BE ANNOUNCED SOON Price: $1,295.00 Discount: Register now and save $200. (Early Bird) Until September 10, Early Bird Price: $1,295.00 from September 11 to October 21, Regular Price: $1,495.00 Contact Information: Event Coordinator Phone: 1800 447 9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: https://www.globalcompliancepanel.com Event Link: http://bit.ly/quality-system-regulations LIVE CHAT SUPPORT - http://www.globalcompliancepanel.com/chat/client.php NetZealous LLC, DBA GlobalCompliancePanel, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Phone: 1800 447 9407
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