Site Preparation Strategy and Successful FDA 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.

She has also authored, reviewed, complied, and submitted numerous FDA submissions (IND, NDA, DMF, amendments, and supplements) on her client’s behalf. She is expert in assessing product and facilities and performs gap analysis relative to FDA requirements. She has hosted many FDA inspections for PAI and facility registrations and has helped clients with their compliance issues with FDA to respond to FDA warning letters and successful remediation with FDA.

Topic Background:

FDA inspections are the most rigorous inspections among the healthcare agencies. The FDA is always known as gold standard when it comes to inspecting of a facility and protecting public health. The FDA’s goal is to determine companies’ compliance level with regulations and the Food, Drug and Cosmetic act; and inspections are one of the ways that the FDA protects public health in the US.

Inspection reports are public information and companies’ reputations are at stake when they don’t meet the level of compliance that is required.

Most foreign inspections are either pre-approval inspection (PAI) or a cGMP inspection to evaluate the capability of manufacturing facilities in producing safe and high quality products. A few years ago all foreign inspections were announced inspections, but nowadays they are performed unannounced. So sites should always be ready for an inspection by local or international health authorities.

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