3 hrs Virtual Seminar Internal Auditor Training

12:00 PM ET | 09:00 AM PT | 11:00 AM CT Duration 180 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 180 mins Live Webinar

"Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations"

Acquire the knowledge and skills to conduct GMP Internal Audits

Description

Regulatory agencies require pharmaceutical and medical device companies to have a systematic approach to assessing the health of their quality system.  It provides management with information about how effectively the company controls the quality of their processes and products.
Today’s pharmaceutical auditor needs auditing skills, technical skills and up to date knowledge of the latest regulatory requirements in order to make that assessment.  
Whether you are just beginning in pharmaceutical auditing or need to strengthen your internal skills, this 3-hour online seminar gives you the ability to conduct effective and efficient internal audits.
This course is for those intending to acquire the knowledge and skills to conduct GMP Internal Audits as an Internal Auditor.
Course attendees will gain the skills to properly plan, conduct, report and follow up on audit findings in order to establish compliance or non-conformance to applicable regulatory requirements.

Course Objectives:

  • Help make you a better auditor by developing your auditing skills
  • Enable you to conduct audits of any element of the pharmaceutical quality system 
  • Provide a foundation for continued professional development in auditing
  • Understand the regulatory requirements governing Internal Audits
  • Have knowledge about audit planning, conduct, report writing and follow-up
  • Know the key skills and techniques for managing an audit
  • Have developed the essential soft skills of a good auditor

Areas Covered

Topic 1:  Regulatory Guidance Review

Increased knowledge of cGMP concepts and regulatory requirements related to auditing 

  • FDA (CFR)
  • EU (EudraLex)
  • ICH Q10

Topic 2:  Auditing Techniques

  • Quality Management Systems and auditing
  • Understand the concepts behind compliance auditing 
  • Types of audits and reasons for performing them
  • Traits/Skills of a Good Auditor 
  • Identify the critical competencies needed to be a conscientious auditor
  • Good auditing techniques
  • Potential Interview Problems

Topic 3:  Conducting the Audit

  • Effective audit planning and preparation
  • Review of documentation before the audit
  • Common Items to look for in an Audit
  • Classifying, Managing, Justifying your findings
  • Prepare and conduct audits using an audit trail and checklists
  • The opening meeting
  • Conduct an audit using an audit trail and checklist
  • Identify critical components for a good audit report
  • The closing meeting
  • Finding faults and identifying opportunities for improvement
  • Non-conformity reporting and corrective actions
  • Audit reports and post-audit activities

Topic 4:  Review Elements of a GMP Compliant Internal Program

  • Certify auditors
  • SOP
  • Schedule
  • Audit template

Who will Benefit

This course is aimed at new and experiences Internal auditors with the objective of showing them how to perform effective and efficient audits in a pharmaceutical environment.
This Internal Auditor course will benefit people who perform internal and external audits, manage audit programs; as well as, individuals who host auditors of their own organization.

Employees that participate in Manufacturing, Engineering, Validation, Quality Assurance, and Regulatory Affairs as part of their job function – includes employees in the following departments:

  • Quality Assurance
  • Regulatory Affairs
  • Production
  • Engineering & Validation
  • Facilities / Maintenance

Industries who can attend

This 180-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

Kelly Thomas

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations.  Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.  
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

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