This live training webinar will provide valuable information on the latest requirements of an effective batch record review process from an operational and regulatory perspective. It will interpret what the FDA and other regulatory agencies such as Health Canada and EU say and what they mean and expect. It will describe how and when to implement a system that is lean and cost effective yet compliant, in an ever-changing regulatory landscape using quality risk-based methods. It will describe how to keep appropriate control over the processes and products without burdening the business. These tiered, risk-based processes will allow low risk elements to be evaluated quickly, effectively and simply yet exert appropriate checks and controls on those which can have high impact on your product and the patient. It will include models of systems that will allow you to benchmark your processes to determine whether they are as robust and efficient as you believe. With the introduction of new technologies, we will examine how the batch record review process is changing to accommodate them. Case studies will be included so you can examine your own operations for telltale signs of potential failure or weakness.

Learning Benefits:

• The key elements of the batch record review process.
• What to look for and how to remedy the issues.
• Pointers on Good Documentation Practices.
• How the latest technologies are changing the way we review batch records.
• >How the FDA, EMA and other agencies are changing their expectations of batch record review.
• FDA, EU and Canada regulatory requirements for the batch record review process.
• How Quality Risk Management can be used to your advantage to focus on the really important aspects of review.
• Some useful metrics to measure your operational performance.
• How to rapidly identify degradation of operational performance and correct it before it negatively impacts your bottom line.
• How companies fail to live up to regulatory and business expectations so you can avoid these pitfalls.

Regulations that will be Covered:

Each country has its own specific set 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.
• Health Canada regulations for pharmaceutical and biotechnology products including appropriate annexes such as 1, 2, 3, 18.
• EMA Eudralex Volumes 1, 2, 3, 4, 9 for Drugs and Biologics in EU, including Annex 13. International Conference on Harmonisation Quality Series Q1 through Q11 for USA, EU, Japan and other countries with an emphasis on ICH.

Webinar outline and time breakdown:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

10:40 AM The role of batch record review in lot disposition,
What do the regulatory agencies expect you to do,
What a batch record contains and why,
Key elements to consider when reviewing a batch record,
Good Documentation Practices,
Risk based approaches to help streamline operations,

11:30 AM 10 Minute Break

11:40 AM Technology and how it is changing the process,
Where and how you can save resources in your review,
Moving towards right first time with batch records,
Metrics to help you identify issues,
Designing for the customer (production and QA),
Case studies of companies who failed to meet patients and regulatory agencies' expectations,
How companies fail to live up to agency requirements,

12:30 PMLive Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

• A copy of the presentation slides
• A certificate of training for attendee training records

Who should attend:

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

• Quality Assurance Personnel
• Quality Control Personnel
• Supply Chain and Logistics Managers
• Regulatory Affairs Professionals
• Process Development Scientists and Management
• Senior Management
• Project Managers working in the CMC arena

How to Attend:
All Pharma Webinars live training programs audio and visuals are delivered via Cisco WebEx with a basic system requirement of a computer with internet access. You do not require a Webex account to join Pharma Webinars’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.