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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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)