Training Course Syllabus:

Auditing API Facilities

Objectives of the Presentation

• How to prepare for an audit


• What is needed prior to audit


• What to send API manufacturer prior to audit


• How to start and audit


• How to develop an audit plan


• What are main items of an audit


• Key to a plan tour (recommendations of a path)


• Audit reporting


• After audit observations


• Review of response and resolutions

Why Should you Attend

If you or your company uses or purchases API and or manufactures or tests API, then you can benefit from this webinar. You will be able to profit from the instructor who has experience in the manufacturing and testing of API and an understanding of the regulations and guidances that have applied to these materials. Understanding the rules of the game will make you a better and a more effective auditor. Learn what you need to review before you audit, what you need to focus on when performing an audit, and when you need to send a strong and direct message to the firm you are auditing - even if that firm is your own!

Areas Covered

• Internal Audit


• Quality Assurance


• Quality Control


• Laboratory


• Technical Services


• Validation


• Operations

Seminar Summary:

This webinar discusses auditing of Active Pharmaceutical Ingredients (API) facilities which is an important component of GMP quality assurance programs of pharmaceutical and biopharmaceutical firms. It is important to establish auditing function as part of a quality system and maintain monitoring and assessing it over a lifecycle of a product. This webinar will outline preparatory steps, pre-audit documentation and preparedness, as well as major topics of audit concentration of an audit. We will go over important questions to ask and necessary quality systems to review. We will also outline suggested areas for plant tours and pointers on what to look for. We will also review Industry Organizations such as APIC guidances for auditing. (see full course description)

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