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Thursday, October 22 2020

Wednesday, Jan 1, 2020 midnight
Multi-day Event
Online Courses

Online Course - 2 Hours

Course Overview:

Enjoy this webinar on your own time at your own pace!

Defensibility of data is a key issue in the laboratory.  Laboratories reporting data for regulatory bodies are required to train employees in data integrity and ethics to ensure that proper laboratory technique is used for generating data.  The training will cover common indicators for laboratory fraud and how the supervisor or data reviewer can develop a program to ensure data generated in their laboratory is defensible and complete.  An in depth internal auditing program is important to discover and rectify any evidence of laboratory fraud.  And real world examples and a checklist will be demonstrated to aid in the effective auditing of integrity practices.  Employees rarely choose to commit fraud in the laboratory and it is usually the lack of knowledge on proper record keeping or technique.  Education provides best practices and establishes expectations for the proper method of testing and reporting sample information.  Fraud can impact all industries.  This course will address data integrity and ethics in the laboratory.

This class will meet the requirements for initial and annual employee Data Integrity training for TNI and QSM/DOD.

Key Session Topics:

  • Data Integrity and Ethics Regulator Requirements
  • Laboratory Fraud
  • Laboratory Oversight and the Internal Audit
  • Prevention
  • Reporting Issues
  • Laboratory Employee Responsibility

QUESTION & ANSWER TIME - "ASK THE ASSESSOR"

  • Gain insight and best practice advice and tips

Certificate of Attendance

  • All registered attendees receive a certificate of attendance

Who Should Attend:

Pharmaceutical, Environmental (TNI and QSM/DOD), Commercial, lab analysts, lab managers, quality managers, and plant managers.


Group Discount:

Group Discounts are available! Contact a Labtopia representative for your unique discount code Group Discount Code Request 

 

Friday, Oct 16, 2020 midnight
Multi-day Event
Online Courses

Online Course - 1.5 Hours

Course Overview:

Enjoy this webinar on your own time at your own pace!

This webinar provides an overview of the ISO/IEC 17025:2017 standard for technical personnel. This course will explain the requirements of ISO 17025:2017 as it applies to their day to day activities.  The analyst will gain an understanding of the overall requirements related to all aspects of sample management.

Key Session Topics:

  • Overview of ISO 17025 Standard
  • Understanding the elements of ISO 17025 for technical personnel

Assesor Best Practice Advice

Gain insight and best practice advice and tips from a certified ISO 17025 Lead Assessor

Certificate of Attendance

  • All registered attendees receive a certificate of attendance

Who Should Attend:

  • Conducting testing or calibration
  • Supporting laboratory activities
  • Managing the laboratory quality system
  • Training laboratory staff
  • Managing the laboratory

 

Course Requirements:

All attendees are required to own their own copy of the ISO 17025:2017 standard as this course includes items cited directly from the standard. By registering for this course, you agree that you or your company owns a copy of the ISO 17025:2017 standard.


Group Discount:

Group Discounts are available! Contact a Labtopia representative for your unique discount code Group Discount Code Request 

 

8:30 AM - 4:30 PM
Tuesday, Oct 20, 2020 8:30 a.m.
Multi-day Event
Labtopia Classroom Courses

Course Overview:

This highly participative 3-day course provides comprehensive instruction on auditing quality management systems based on the ISO 13485:2016 requirements. The training will provide an understanding of the ISO 13485:2016 requirements to be able to conduct a process-based audit.   The course includes a practical workshop based on actual auditing situations to enhance auditor’s skills and techniques. Reference is made to the regulatory requirements for medical devices on quality management systems. 

Student Prerequisites: 

Each student shall be required to have studied the current published version of ISO 13485:2016 prior to attending the course.  Please bring a copy of the standard with you to the course.

Key Session Topics:

  • Describe ISO 13845 Quality Management Standards Requirements and related standards.
  • Understand how internal audits perpetuate continual improvement within the company.
  • Understand audit and medical device terminology.
  • Learn how to construct an audit program and prepare for internal audits to maximize benefits of the activity.
  • Apply process approach and Plan-Do-Check-Act (PDCA) methodology.
  • Demonstrate effective audit techniques and personal behaviors necessary to conduct an efficient management system audit.
  • Identify organizational deficiencies to ISO 13485:2016 requirements based on evidence collected.
  • Apply the principles, methods and processes of auditing.
  • Understand how to audit, report and follow-up on nonconformities effectively.
  • Overview of ISO 13485, FDA 21 CFR Part 820 Quality System
  • Coordinate a quality management system audit
  • Management responsibilities to customers, personnel, materials, infrastructure, and facilities
  • Audit effectively
  • Incident reporting, technical files, and risk analysis
  • Prepare nonconformity statements
  • Evaluate the significance of audit findings
  • Methods for improving communication skills
  • Report audit findings and conclusions
  • Develop and implement corrective action programs
  • Evaluate corrective action responses
  • Effectively follow-up audit findings to recognize if the nonconforming situation has been effectively resolved
  • Understanding the difference between quality system registration and accreditation
  • Preparing specialized checklists for the laboratory environment
  • Product realization from planning to design
  • Identify the evidence needed to demonstrate conformity

 

Course Outline:

Day 1

  • Quality Management System Overview & Principles
  • ISO 13485:2016 Quality Management System Standards Overview
  • Management Responsibilities
  • Product Realization Documentation
  • Design & Development
  • Risk Management
  • QMS Terminology
  • What is an Audit?
  • Audit Types
  • Audit Evidence

Day 2

  • Internal Audit Program
  • Internal Audit Team
  • Auditor Competence
  • Roles
  • Audit Techniques
  • Four Phases of the Internal Audit Process
  • Audit Planning
  • Audit Conduct
  • Audit Reporting
  • Audit Follow-Up

DAY 3 (Audit exercise)

  • Development of Audit Plan
  • Preparation of the Audit
  • Conduct of Management System Audit (mock)
  • Draft Nonconformities
  • Closing Meeting
  • Audit Reporting/Corrective Action Requests

 

QUESTION & ANSWER TIME - "ASK THE ASSESSOR"

  • Gain insight and best practice advice and tips

WHO SHOULD ATTEND

Personnel responsible for planning and scheduling the internal audit program for ISO 13485:2016 and those who must perform audits of the company’s quality management system.


Labtopia offers group discount rates for all training events! Click here to learn more!