How to Develop and Implement an Efficient and Effective Audit Program 2017
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.
Overview:
• 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
Agenda:
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/Per
Overview:
• 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
Agenda:
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/Per
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