Auditing is a critical function within and for a pharmaceutical company. It provides management with information about how effectively the company controls the quality of their processes and products. As a GMP licensed manufacturer, you should always be ready for an audit. Regulators can perform ‘unannounced’ audits at any time. This course will define how a company can always be ready for audits from USFDA GMP & EU GMP.

^{_{Who Should Attend}}

• Professionals who are responsible from implementation Quality Management Systems for the pharmaceutical manufacturing companies
• Individuals who are audited, such as quality assurance and quality control specialists, validation scientists, manufacturing supervisors, technical support personnel, engineers, and all levels of management

^_Outlines

• Understanding FDA & EU GMP expectations
• Preparing your site
• Generating documented evidence of compliance with FDA & EU GMP regulations
• Interacting appropriately with FDA & EU GMP inspectors
• Managing the inspection on the day of the audit.
• Inspection management planning
• Training requirements of the company personnel about Do’s and Don’ts of the audits
•  Secrets for success