Auditing API Facilities: A MUST to properly prepare for an FDA Regulatory API GMP Inspection

Why Should You Attend:

Preparing properly for an FDA inspection, is the most cost effective way to be successful during an FDA inspection. The costs associated with this program or applying corrective actions prospectively at this point, is a firm’s best way to minimize wasted efforts and expenses.

Attending and implementing what is discussed during this program has shown itself to help companies not only avoid embarrassing situations, wasted time, while improving product quality, reliability and effectiveness.

Attending this program improves your ability to better prepare for a successful FDA inspection:

• Will help participants be better prepared to complete a regulatory review of an API site
• Learn where to focus corrective actions
• Find “the smoking guns” at a facility or site
• How to improve a site’s readiness for an FDA inspection
• Identify and avoid “Smoking Guns” during inspections
• Learn where to focus your attention to minimize or eliminate problems during an API Audit or inspection

This program will help you identify a process to follow, what to avoid and how to enter and exit from an FDA inspection successfully.

Areas Covered in the Webinar:

• Discusses what will be covered during this program
• What is the most critical understanding needed for success
• Suggested process to follow including: what to review before and during the audit
• What and where to look
• No smoking guns observed
• No Data Integrity Issues Observed
• Review all appropriate areas including Critical Operations/Systems/Records
• How the Audit should Start and End
• Where are the key areas and systems
• Opening/Ending/ and Follow-up Actions to the Audit

Who Will Benefit:

The Target audience should include Quality, Manufacturing, Engineering, Distribution, and regulatory management and key personnel. Paricipants would be from Firms that produce, consume, ship or store API. Attendee should come from Directors, Managers, Supervisors or personnel that are responsible for any GMP related function for a firm above the first level are potential candidates for attending this program.

It is important, that First level personnel should always understand, through other training, what is expected during an inspection or an audit!

Max Lazar
Owner, FDA Regulatory Compliance Consulting

Max Lazar retired from Hoffmann-La Roche Inc. in 2001 after 35 years. At that time, he was Vice President, FDA & DEA Compliance reporting to the firm’s President. Over his career, he progressed from a QC bench chemist through increasing titles and responsibilities, reaching his ultimate responsibility for Compliance oversight of the Roche USA businesses including Active Pharmaceutical Ingredients, Pharmaceuticals, R&D, Diagnostics, and Fine Chemicals and Vitamins. Following his retirement, he was approached to establish a consulting business specializing in API GMP issues and the training of personnel in both API and other drug related GMP.

His more than 50-year career in the Pharmaceutical Industry includes numerous memberships and chairs of committees. He represented USA industry at the PIC/S Canberra Australia Conference which preceded the ICH API activities and worked with FDA during the 1980 – 2000 era addressing API industry related regulatory issues. He was one of five invited industry representatives at the WHO/CDC/FDA Diethylene Glycol Contamination Prevention Workshop that followed the Haitian tragedy where almost 100 children died. This workshop developed recommendations for consideration by the Pan American Health Organization and WHO. Max was named as PhRMA’s representative on the FDA PQRI initiative that developed the initial Bulk Substance projects and is a current member of existing USP water panels. 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 is a member of numerous professional organizations and is listed in numerous editions of Who’s Who including Who’s Who in America.

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