Online Webinar 2019 - 3 Hrs Live Webinar Internal Auditor training

Session Highlights
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
Overview
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.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
Who will benefit
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
Speaker
Ms. Kelly 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.