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.
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!
- Internal Audit
- Quality Assurance
- Quality Control
- Technical Services
This webinar will be valuable for you if your firm produces or uses API. This webinar outlines reasons for importance of audits, their preparation and discusses recommendation for best execution of audits. It also discusses FDA and other regulatory bodies GMP requirements and expectations. The webinar will help firms and auditors identify an appropriate process to follow and implement to maximize the benefit of the auditing of API and related operations such as pharmaceutical excipients.
Senior Consultant ,
Igor Gorsky has been a pharmaceutical industry professional for over 30 years. He held multiple positions with increasing responsibility at Alpharma, Wyeth and Shire. He worked in Production, Quality Assurance, Technical Services and Validation including an Associate Director of Global Pharmaceutical Technology at Shire Pharmaceuticals. He is currently holding a position of Senior Consultant at ConcordiaValsource, LLC. His over the years accomplishments include validation of all of the aspects of pharmaceutical and biotechnology production and quality management, technical support of multi-billion dollar drug product lines and introduction of new products onto the market. He had published articles and white papers in pharmaceutical professional magazines and textbooks. In addition he had been a presenter at Interphex. He is also very active with PDA participating in several Task force groups authoring PDA Technical Reports 29 (Points to Consider for Cleaning Validation) and 60 (Process Validation). He is leading PDA Water Interest Group. He holds a BS degree in Mechanical and Electrical Engineering Technology from Rochester Institute of Technology.
- Operations/Manufacturing Management Personnel
- Quality Control Management Personnel
- Quality Assurance Management Personnel
- Internal Audit Personnel
- API Product and Process Development Management Personnel
- Laboratory (Chemical and Microbial) Analysts and Management
- Warehousing Management Personnel
- Sampling and testing staff and in-process testing personnel
- Technical Services Personnel
- Validation Personnel