$1,295 – $3,885

Effective Internal and External Quality Assurance Auditing for FDA Regulate...

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Philadelphia

Philadelphia, PA

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Description

Course "Effective Internal and External Quality Assurance Auditing for FDA Regulated Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


  • Principles and Audit Planning
  • Planning and preparation
  • Internal audits are critical element of your quality management system.
  • Your approach must be both systematic and documented to remain compliant
  • Information from an internal audit provides management with the knowledge they need to show how effectively the company maintains the quality of the product and their processes
  • Audit types and techniques
  • Establishing an audit program for suppliers, contractors and company sites
  • Internal vs. external audits
  • The audit processes
  • Regulatory Expectations
  • How to develop and implement an efficient and effective audit program
  • Common problems
  • Red-flags that your program is not effective
  • Risk Analysis techniques
  • Audit Program Structure
  • The auditing process - steps and tools
  • Documentation and communication
  • Linkages within your Quality System to ensure audits lead to effective solutions and lasting improvement while reducing regulatory and compliance exposure
  • And Much More...

Why should you attend:

  • Clear Understanding of Auditing Fundamentals
  • Understand Audit Preparation and Planning
  • Learn best techniques for Audit Performance
  • Learn best practices for Audit Reporting
  • How to address Audit Follow-up and Closure efficiently and effectively
  • Understand the requirements and expectations for being an effective auditor
  • How to develop into an even better auditor
  • How to structure, plan and manage your audits
  • How to develop your technical and non-technical skills
  • How to perform your best audit ever

Areas Covered in the Session:

  • The fundamentals of process based auditing
  • Four Phases of Auditing: Preparation, Performance, Reporting, Follow-up & Closure
  • ISO 19011 is the standard that sets forth guidelines for auditing management systems
  • Different Types of Audits: Product, Process, System, Quality System, Supplier, Regulatory, Quality System, etc.
  • More robust methodologies for preparing and conducting audits
  • Auditor competence
  • Enhanced audit criteria that consider efficiency and effectiveness
  • Applied statistics for auditing when it's necessary

Who will benefit:

This seminar will provide an overview and in-depth snapshot and a refresh of internal and external auditing. Those interested in how to prepare for a QA audit and how to enhance their internal/external quality audit system as a valuable regulatory compliance tool will also benefit from this course. Employees or functional areas who will benefit include:

  • Clinical Research Associates
  • Clinical Project Managers
  • Regulatory Affairs Professionals
  • Clinical Investigators and Clinical Research
  • Regulatory Affairs Management
  • Regulatory Affairs Specialists
  • Regulatory Project Leads/SME's
  • QA Auditors
  • Supplier Auditors
  • GxP Auditors
  • Compliance Specialists
  • Clinical Affairs
  • Quality Manager
  • Quality Assurance
  • Production/Operations
  • Consultants


Day 1 Schedule


Auditing
  • Introductions and Background
  • Four Phases of Auditing
  • An auditor may specialize in types of audits based on the audit purpose, such as to verify compliance, conformance, or performance
  • Some audits have special administrative purposes such as auditing documents, risk, or performance or following up on completed corrective actions
  • Purpose and Scope of the internal and external Quality Audit System
  • Responsibilities and Authority
  • Types of Audits
  • Roles and Responsibilities
  • Audit Plan
  • Audit Team
  • Audit process
  • Auditor Skills and Competencies
  • What makes a good auditor?
  • Communication skills - questioning and listening
  • Body language and non-verbal communication
  • Overcoming apathy, resistance and aggression
  • Effective note taking
  • Auditor continuing professional development
  • Assessing the auditor
  • Managing auditors
  • Writing ideal Audit Reports
  • Corrective action follow-up and interactions with the Auditee
  • Regulatory background - requirements for each type of operation
  • Strategies and Techniques of auditing
  • Regulatory Inspections and the correlation to Audits
  • Auditing Guidelines and Resources

Exercise and Recap of Day 1
  • Interactive Discussions
  • Review of Auditing Documents

Day 2 Schedule


Auditing
  • Recap from Day 1
  • Tools for documenting audit observations and managing corrective and preventive actions
  • Good Clinical Practice Audits, Good Laboratory Practice Audits and Good Manufacturing Practices/Quality System Audits
  • Supplier Audits
  • Process: Planning, Scheduling, Audit Conduct/Performance, Reporting of Audit Results and Next Step
  • Show the auditor you do what you say
  • Tips for Passing Your FDA, Internal and External Audits with Confidence
  • Best Practices for Auditing

Exercise and Recap of Day 2

  • Interactive Discussions
  • Review of Auditing Documents

Debrief/Adjourn
  • Recap of topics and key discussion points and take away message
  • FAQs and latest auditing trends



David R. Dills

Global Regulatory Affairs & Compliance Consultant

David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, warning letters, and customer generated compliance events, conducts QS, regulatory, compliance assessments/audits and FDA Mock Inspections for State of Readiness. He has been directly involved with constructing, reviewing, and remediating regulatory submissions, U.S. Agent for OUS companies, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs/CTM and provides regulatory submissions and post-market project leadership and guidance covering multiple therapeutic and medical specialties based on classification. He has a strong background in the interpretation and applicability of FDA and international regulations, leads activities for the registration and approval process and working with the Agencies in Asia Pacific, EMEA and The Americas, including FDA, European Medicines Agency-EMA, MHRH, ANVISA, PMDA, MOH, CFDA, TGA, and Health Canada and works with management on regulatory strategies and plans supporting a company's commercialization strategy. He directs and leads efforts for PM support involving all phases of the premarketing to postmarketing; establishes Medical Device Single Audit (MDSAP), UDI, and Digital Marketing/Promotion/Advertising compliance strategies; lead efforts regarding AE/Incident Reporting, all aspects of Postmarketing Surveillance and Vigilance Reporting; establish QMS and documentation systems for GxP compliance; ISO 13485 registration and CE Mark, Technical File, Design Dossier and CER consultation; and facilitates multi-country product registrations and licensing. He recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems; documentation development and remediation; regulatory oversight and governance; design controls; CAPA investigations; GxP training; software embedded medical devices/all aspects of SW/SDLC and process validation with compliance oversight; supplier management; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure. Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute, Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers' Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore's Who's Who of Professionals. Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills' academic degrees include Environmental Science and Biology. He is a former Chair and Co- Chair of ASQ's Section 1506 and affiliated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups.


NO REFUNDS ON REGISTRATIONS ALLOWED

NO TRANSFER ON REGISTRATIONS ALLOWED

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