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Batch Record Review Process - 2013 Requirements in an Evolving Regulatory, Operational and Technological Landscape in the US, EU & Canada

A Comprehensive 2-Part Live Webinar Training Program

Part 1: Thursday October 10, 2013 Time 1:00pm to 3:00pm ET
Part 2: Thursday October 24, 2013 Time 1:00pm to 3:00pm ET

Instructor: Peter Calcott Ph.D.
Click Here to Register for the 2 Part Live Training Program

This exclusive 2 part training program will provide valuable information on the requirements of an effective batch record review process from an operational and regulatory perspective. It will interpret what the agencies mean and what they expect. It will describe how and when to implement a system that is both cost effective and 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 and simply yet exert appropriate checks and controls on those which can have high impact on your product. 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 operagtions for telltale signs of potential failure.

2-Part Live Webinar Training Program 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 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.

Part 1 - Batch Record Review Process; 2013 Regulatory Requirements, Using Metrics to Spot Issues & Following Best Practices to Assure an Effective Process
Live Interactive Training Webinar

Thursday October 10, 2013 Time 1:00pm to 3:00pm ET

Webinar outline and time breakdown:

   Time*         Activity

12:45 PM Log In Period
1:00 PM Introduction
1:10 PM 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,
2:00 PM Break
2:10 PM Risk based approaches to help streamline operations,
Where and how you can save resources in your review,
Metrics to help you identify issues,
How companies fail to live up to agency requirements,
3:00 PM Live Questions & Discussion

*Please note all times are Eastern Standard Time

Part 2 - Batch Record Review Process; From an Operational, Regulatory and Technology Perspective
Live Interactive Training Webinar

Thursday October 24, 2013 Time 1:00pm to 3:00pm ET

Webinar outline and time breakdown:

   Time*         Activity

12:45 PM Log In Period
1:00 PM Introduction
1:10 PM Clinical versus commercial operations,
What can be delegated,
Contract Manufacturing and batch review,
Technology and how it is changing the process,
Moving towards right first time with batch records,
2:00 PM Break
2:10 PM Using continuous improvement to your advantage,
Designing for the customer (production and QA),
Keeping the FDA and other regulators satisfied,
KPI's revisited,
Touch points for inspections,
Case studies of companies who failed to meet patients and regulatory agencies' expectations
3:00 PM Live Questions & Discussion

*Please note all times are Eastern Standard Time

Regulations that will be covered:

Each country has its own specific sets of regulations. Below are citations from ICH and examples of regulations that are applicable to the inspection and response processes and philosophy:

Code of Federal Regulations 21 sections 210, 211 for Biological products and Drugs and 600 series for Biologicals in addition for USA
EMA Eudralex Volumes 1, 2, 3, 4, 9 for Drugs and Biologics in EU
International Conference on Harmonisation Quality Series Q1 through Q11 for USA, EU, Japan and other countries with an emphasis on ICH Q1, Q5, Q7

List of handout materials included with this training program:

  • A Copy of the presentation slides
  • Reference to the ICH Guidances

Who should attend:

The following individuals or disciplines will benefit from attending this training program:

  • Senior management
  • Compliance auditors and management
  • Quality Assurance personnel
  • Quality Control personnel
  • Manufacturing management and scientists
  • Process development scientists and management
  • Project Managers working in the CMC arena
  • Auditors

Click Here to Register for the 2 Part Live Training Program>>>