Site Preparation Strategy and Successful FDA Inspection

This webinar will explain the Good Manufacturing Practices (GMP) requirements. Attendees will learn strategies for site preparation and hosting of an inspection.

Why Should You Attend:

Increase in global trade has had an huge impact on all sectors of the economy. Between 60 to 70 percent of food and healthcare products are traded in the global marketplace. With the growth of imports of food and healthcare products, challenges for maintaining consumer safety also increases and healthcare authorities’ oversight on exporting companies become more apparent. To ensure safety of the products, healthcare authorities continuously monitor and inspect domestic and foreign facilities.

The regulatory and quality units play a vital role in any inspection and site preparation. Compliance with regulatory requirements will translate into a successful inspection. This webinar will help you in understanding GMP requirements and preparing the site for a successful inspection.

Areas Covered in the Webinar:

• GMP requirements
• Overview of types of inspections
• Site preparation activities
• Documentation requirements (procedures, protocol, and reports)
• Role and responsibilities of the personnel
• Inspection process and coordination of activities
• After inspection activities
• Response preparation

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• Quality Assurance
• Quality Control
• Regulatory Affairs
• Quality Compliance
• Operation/Manufacturing
• Validation

Instructor Profile:

Yasamin Ameri, MS. RAC, IRCA & RABQSA Lead auditor, is the president of Quest International Consulting in Lake Forest, California. Ms. Ameri has over 22 years’ experience in design and implementation of quality systems, compliance, and regulatory affairs for FDA regulated drug and device manufacturers. She is expert in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices, and generic drugs. In 2006 she designed a course on regulatory requirement for pharmaceutical products for University of California Extension program and taught that course for 7 years.