Purchase any WEBINAR and get
10% Off
CODE: SAVE10
T&C applicable, please referFAQ
Validity : 19th Apr'24 to 29th Apr'24
Auditing API Facilities
- How to Prepare for performing an API audit
- What is needed before starting
- Differences between internal or external audits
- Opening meeting
- What to look for
- Where to look and why
- Should you use a checklist or not?
- What is the key reference document or policy to use for audit
- Closing meeting
- Agreed upon follow-up
Overview of the webinar
This webinar discusses most, if not all of the important issues surrounding “Auditing of API Facilities”. When and how to perform and audit any API Facilities, how to prepare for an audit, performing an audit, and what to examine during the audit. Discussed are the suggested process to follow from initially scheduling the audit, obtaining information before starting an audit, meeting with site personnel and establishing scheduled follow up on findings.
Auditing API Facilities is an important part of assuring API GMP Compliance. Knowing what to ask, look at, question, observe and document all form an important part of API GMP Auditing. Any auditor selected to perform an API GMP Review should have the knowledge and background in ICH.
This session focuses on how to prepare, what to examine, how to organize and identify what are the important issues that should be examined by the auditor. What are critical to the success of an API firm? The topic reviews what are “critical” to an audit’s success and how a firm has a legal and moral obligation to perform audits in a correct manner and follow-up. Q7 GMP was carefully written and negotiated for application both in the USA and internationally. Don’t misinterpret what it expects.
Who should attend?
- Manufacturing Supervision and Management
- Quality Control/Quality Assurance Management and Supervision
- Drug Ingredient Development Supervision and Management
- Laboratory Analysts and Management
- Warehousing and Storage Supervision and Management
- Chemical and Microbiological Testing Personnel
- Sampling and Testing Staff and in-process Testing Personnel
- R&D Personnel associated with API support and Validation
- Validation Management and Supervision
Why should you attend?
If you or your organization produces or uses API, then this program can be invaluable for you. This program covers why audits are important, how to prepare and perform an audit of a technical operation covered by FDA GMP requirements or expectations. Of special importance is that the program identifies important critical issues for use by the auditor(s).
This 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. The program does assume a basic understanding of Good Manufacturing Practices. However, the presenter’s more than 50 years of experience in this subject allows him to relate to the fundamental needs associated with GMP auditing. This allows an attendee with just a basic understanding of the subject matter can find this program valuable. Don’t miss this opportunity to learn from a real expert in API GMP and understand Q7 expectations and application.
Faculty - Mr.Max Lazar
Max Lazar retired from Hoffmann-La Roche Inc. in 2001 after 35 years, where he was Vice President, FDA & DEA Compliance. In that position, he was responsible for compliance oversight of all of the Roche USA businesses including Active Pharmaceutical Ingredients, Pharmaceuticals, R&D, Diagnostics, Fine Chemicals and Vitamins. Following his retirement, he established a consulting business specializing in API GMP issues and the training of personnel covering the ICH Q7A Guidance as well as the Excipient GMP (IPEC) Guidance. As a voting member of the ICH Expert Work Group (EWG) that developed and negotiated this international standard, Max is uniquely qualified to share and explain the EWG’s intent of this new guidance.
His almost 50-year career in the Pharmaceutical Industry includes numerous memberships and chairs of committees. He founded and chaired the Pharmaceutical Manufacturers Association’s (PMA) Bulk Pharmaceutical Committee of the Quality Control Section. This chair lasted thru the reorganization of PMA into PhRMA and until Max’s retirement in 2001. He has presented at numerous meetings during his career including SOCMA, PDA, DIA, the original IVT, and PhRMA.
Max was named by PhRMA, Topic Leader and voting member of the ICH Q7A team that negotiated and developed the ICH API GMP document. For his contribution to Q7A, he was awarded the USA FDA Commissioner’s Special Citation “For outstanding cooperation and achievement in developing an internationally harmonized good manufacturing practice guidance for active pharmaceutical ingredients used in human drug products.”
He represented USA industry at significant API meetings including the BPC PIC/S Conference in Canberra, Australia and the WHO/CDC/FDA Diethylene Glycol Contamination Prevention Workshop that followed the Haitian tragedy where almost 100 children died. Max was named as PhRMA’s representative on the FDA PQRI initiative for the initial Bulk Substance projects. He was Vice Chair of the USP Pharmaceutical Waters Expert Committee (2000-2005), re-elected to another 5-year term (2005-2010) as a member of this USP Expert committee, and is currently an official member of the USP water panels (2010-2015).