Webinar Duration: 60 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: Joseph Habarta
OVERVIEW:
This course will describe the basis for the performance and tools and techniques for performing internal audits in support of the development and manufacture of a pharmaceutical drug product.
The presentation will describe the role internal audits play in assessing a company’s compliance to GLP and cGMP regulations and in the development of a Quality System. The role of internal audits as part of CAPA related to internal (incidents, deviations) or external (regulatory inspectional observations) will be discussed. The role of senior management will be described in assuring compliance and follow-up to internal audit observations and corrective actions.
Tools, formats and strategies used for internal audits will be presented and discussed. Who comprises an internal audit team and why. Formats for conducting an internal audit, providing feedback, writing reports and assuring compliance to observations will be presented. How to approach the creation of a risk based gap analysis grid for use during internal audits and what you should and should not show a regulatory authority inspector during a regulatory inspection.
Why should you Attend: A successful robust internal auditing program allows you to understand your processes and assure a high level of compliance and discover the GAPs needing attention BEFORE the FDA!
An understanding of the why and how of internal auditing, and the practical tools, formats and approaches to use for internal audits. Among these will be techniques to use in difficult situations and the many different types of internal audits.
Areas Covered in the Session:
– The regulatory requirements for internal audits.
– The role internal audits play in different circumstances and functions (process improvement, development, pre-PAI, general GMP,)
– How to identify a “To Do” list of their most urgent action items related to internal audits
– Auditors and the auditing organiz
– Preparing an annual internal audit plan and checklist
– Preparing an internal audit grid and report
– Management involvement and communication
– Understand how effective audit feedback is provided
Who Will Benefit:
– Quality Assurance Director, Manager and Supervisor
– Quality Assurance Specialists
– Production/Operations Director, Manager and Supervisor
– Senior Production personnel
– Virtual or semi-virtual companies, start-ups and large pharma companies
SPEAKER PROFILE:
Joseph Habarta Ph.D. is founder and principal of J. Habarta Consulting that provides specialized consulting and assistance in the areas of international GMP and quality for the biotechnology and pharma industries. Dr. Habarta brings over 35 years of experience in these industries and has been a senior quality executive in both large pharma and start-up biotech organizations. His accomplishments range from numerous successful international PAI inspections to the establishment and advancement of cGMP quality organizations in many companies.
