Training & Events

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Presented By: Peter Calcott Ph.D.
You are well into your phase III trial and you believe you have a potential blockbuster on your hands. You are beginning to write your pivotal submission and you know the PAI is still a long time from now. Knowing the precise time to begin the preparation for the PAI is critical. Even if you start on time, there are many elements that must be completed before the agency arrives at your doorstep. The execution of these tasks is important so that you have available all the relevant documents, a fully trained staff and a knowledge of your processes and data. Having these effectively in place helps you to meet the expectations of the agency. An important aspect of the task is to objectively assess where you are deficient or weak. The gap analysis helps you identify these and helps you prioritize where to focus. People are your biggest resource and potentially your biggest weakness, so an effective training program with plenty of inspection practice is critical. An assessment of your people to determine who should be talking with the agency and, most importantly, who should not must be performed. During the inspection it is important to understand how to manage the expectations of the agency and when you receive your observations how to develop and present a compelling response to them to the agency

This webinar will provide the process map for the compliance and quality staff to build their strategy and plans for preparing for and executing their preparation work for a PAI in the Pharmaceutical and Biotechnology world. It will describe techniques to aid in the running of the inspection and how to best prepare your responses to the observations you will receive. It will describe how to develop and implement an effective CAPA program to track progress in closing your gaps and to track progress against your commitments.

Because the pre-approval inspection is an integral component of the drug review and approval process and is often on the critical path, failure to pass the inspection first time round can have dramatic effects on the timing for approval of an otherwise efficacious and safe drug. Poor preparation for an inspection can lead to significant findings in the inspection which can consume valuable resources in managing the inspection and responding to the agency. These activities, if poorly executed, can delay approval, which can have significant impact on company image and shareholder value. A preapproval inspection that results in further regulatory actions can not only impact the product in question but also on other products manufactured by the company at that site and even further. All of these consume valuable resources, slow down progress and result in negative perception of the company especially in the marketplace.

Learning Benefits:

• What needs to be ready before the agency walks in.
• What the agency’s expecting are and how to manage to them.
• When you should begin to prepare for the inspection.
• Who needs to be available (including the CEO) for the inspection and how to train them.
• What is fair game in the inspection.

Regulations that will be Covered

• Each country has its own specific sets of regulations. Below are examples of regulations that are applicable:
• Code of Federal Regulations 21 sections 210, 211 for Biological products and Drugs and 600 series for Biologicals in addition for USA
• EMEA Eudralex Volumes 1, 2, 3, 4, 9 for Drugs and Biologics in EU
• International Conference on Harmonisation Quality Series Q1 through Q10 for USA, EU, Japan and other countries.

Who should attend:

The following individuals or disciplines will benefit from attending this Webinar:

• Quality Assurance personnel and management
• Quality Control personnel and management
• Compliance staff and auditors
• Manufacturing management and scientists
• Process Development management and scientists
• Validation management and staff
• Regulatory Affairs Professionals
• Project Managers working in the CMC arena
• Senior management and executives

Webinar outline and time breakdown:

• 11:45 PM Log In Period
• 12:00 PM Introduction
• 12:10 PM Pre-approval inspection as a key component of product approval,
  • Preparation for a pre-approval inspection,
  • Who are the customers and who are the owners,
  • Timing of the inspection,
  • Content of the inspection,
  • Linkage between development and operations,
• 1:00 PM Break
• 1:10 PM Quality systems in action,
  • Issues to be concerned with,
  • Preparation tactics,
  • Physical elements for success,
  • The actual day of the inspection,
  • Responding to the agency,
• 2:00 PM Live Questions & Discussion