Course Description:

A glance at the FDA's citations for quality system deficiencies show that these usually relate to change control, employee errors, Corrective and Preventive Action (CAPA) and consistent process control as demonstrated through validation and incident tracking systems.

Upon completing this course, participants will be able to:

  • 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
  • Generate a Drug Master File (DMF)

This course will focus on the following topics:

Prepare for the FDA’s systems based inspection

  • Difference between QA and QC
  • Difference between “correction” and “corrective action”
  • Quality planning and development
  • Quality manual
  • Difference between polices, practices and procedures
  • Components of QA and QC
  • Functions and responsibilities as well as qualifications
  • Checks and balances based on the regulations to assure quality
  • Guidelines for quality systems and controls including audits, CAPA and change control which also has to include customer complaints

Six Quality Systems as well as Six Sigma – How to use and when

  • Current GMPs (CGMP) at this time with changes occurring often and steps to success
  • PAT with, CAPA and change control to generate comparability protocols and continuous quality improvement

Principles of Quality Risk Management

  • Q7A API Guidelines
  • Mastering quality performance throughout the entire process
  • Process validation, methods validation, computer and software validation
  • Conducting proper quality control audits

This highly interactive course will help attendees learn how to use the FDA Quality System Inspection Techniques (QSIT), QTA guidelines and CFR quality regulations not just specifically for devices and APIs. It will also provide methods of problem solving in order to develop and implement systems and improvements that can be demonstrated as effective, consistent and reliable once implemented. Through industry related examples, this course will examine best practice quality systems to provide thoughts and ideas to improve the performance of your current system. Additionally, case studies will explore how your quality management practices can help or hurt your legal liability and the legal issues that arise from nonconformance with regulatory agencies.

Participant Benefits : Organization Benefits :
  • Understand the elements of the quality system 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
  • Operate a GMP compliant manufacturing operation that supports changes to facilities, equipment, and processes to support product improvement
  • Save money and ensure product quality by encouraging “Quality by Design”
  • Improve product safety and integrity through increased quality monitoring at all stages of the manufacturing process

Learning Objectives:

  • Expectations from the QA professional and how other industries (FAA, ISO, EPA, etc.) have made quality systems profitable
  • Gaining a more practical comprehension of Quality Systems Regulations
  • Identifying the necessary activities like working on a thesis to generate the needed performance for the entire quality system.
  • Applying current technology to generate the objective evidence for successful FDA inspections
  • Documenting evidence to prove that the process and initial validation is still working in accordance with the Quality System Regulations
  • Using proper tools to perform internal audits that can prepare a facility for future client/FDA inspections
  • Managing laboratory, inspection, calibration, and related quality verification activities so that continuous quality improvement (CQI) is generated
  • Managing vendor’s quality performance
  • Understanding Good Documentation Practices (GDP)
  • Managing incident tracking systems (ITS), deviations (OOS, OOT, OOL, etc.), Critical Change Control (CCR) and Corrections, CAPA.
  • Creating and maintaining Batch Production Record (BPR) or Device History Record (DHR)
  • Proper usage of statistics for quality systems and Six Sigma

Who will Benefit:

This course is designed for people involved in maintaining and improving quality systems for drug and medical device manufacturers. This includes individuals that have ISO 9001/AS9100/TS 16949/ISO13485 Quality Management Systems responsibilities for making general improvements in their organization’s performance specifically related to CAPA. Following personnel will benefit from the course:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Design engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists
  • Record retention specialists
  • Medical affairs
  • Legal Professionals

Topic Background:

The average cost of a Warning Letter remediation effort is estimated at US $750,000 or millions depending on the product and the efforts 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.

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the company that developed the patented or confidential information. One needs to understand the acceptable approaches to meet regulatory requirements for a DMF. Different approaches may be followed, but the applicant is encouraged to discuss significant variations in advance with FDA reviewers to preclude spending time and effort in preparing a submission that FDA may later determine to be unacceptable.

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  • Job functions
  • Quality systems
  • Quality compliance
  • Method development and related activities associated with technology transfer – quality testing as well as production
  • Validation, verification and on-going cost savings programs to generate Continuous Quality Improvement (CQI)
  • How to ensure the FDA inspector is impressed

Note: Each attendee will get a copy of the workbook to be able to get their company in quick compliance.

  • Quality Assessments in compliance with QSIT (statistics, incident tracking, Six Sigma, audits, lab tests, inspections, document control, etc.)
  • Quality agreement regulatory requirements and vendor inspections
  • How to generate the proper “legal documents” that must be in compliance with the company’s specific GDP requirements
  • Managing Incident Tracking System and customer complaints to minimize patient risk (CAPA and change control management, etc.)
  • Regulatory requirements for setting up procedures and BPRs / DHRs including the Master Records
  • Using all the above to make adjustments to the company’s regulatory submissions and the related DMF when applicable

Meet Your Instructor

Jerry Dalfors
Biopharmaceutical Technical and Compliance Consultant, JD Technologies, LLC

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 an 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 as well as reducing costs to make companies more profitable.

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