While operating your commercial manufacturing according the GMP's can be difficult, adhering to the regulations during manufacture of materials destined for clinical trials poses even more challenges. Unlike commercial operations where operations are well defined and processes are validated, clinical manufacturing processes are in a constant flux. In the same way your testing is also evolving as the knowledge of your product and processes increases. How can we maintain GMP's in this evolving world of constant change? It is a challenge that many companies face and have difficulty with. It requires the manufacturing organisation to retain flexibility and agility of operation, but it requires more from the Quality organisation. These staff must retain appropriate levels of control where needed, yet exhibit flexibility when required. Does that mean that GMP's do not apply or we administer GMP-lite? No. Rather we tailor the GMP's to meet the challenges of the special circumstances of the operations. In some cases, we allow great flexibility and in others we enforce tighter controls. Because everything is in flux, we can not build quality into operations and must rely on testing quality in - a cardinal sin in commercial operations. In clinical manufacturing the overall target is to protect the patient in a world of absence of concrete knowledge, especially when not knowing if the product even works.

This live training webinar will provide valuable information designed to prepare you to implement the GMPs differently in the clinical manufacturing setting versus commercial. We will outline the changing world of the operations, as products undergo development and definition, as the stability program evolves and as we set formulations, presentations and expiry dating. All of this while you adjust the GMP's to meet your needs and not losing sight of the goal to protect the patient. It will describe how you judge product quality and acceptability when your knowledge of the product and process is rudimentary and every changing. We will discuss the time when elements must be locked down to assure success in development whilst protecting the patient and assuring success when the product dossier is filed for approval. It will describe tools to help you to make decisions that will be defendable to the company and to the regulators.

Learning Benefits:

• The ever-changing environment of clinical manufacturing and how to interpret the GMP's to your advantage.
• Where flexibility is acceptable and required and where it is unacceptable.
• How to make quality decisions where knowledge is absent or sketchy at best.
• How to build the case for your decisions based on risk analysis.
• When various components of your product and processes have to be locked down to maximise your chances of approval.
• How to interpret the regulations which were designed for commercial operations in a clinical world.
• Where GMP rules are broken and it is acceptable.
• How other companies fail to meet the agency requirements in their operations so you do not have to repeat them.

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.
• 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.

Webinar outline and time breakdown:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

                Why are clinical manufacturing operations different from commercial,
What the regulators say about clinical manufacturing,
Working in an evolving landscape,
How to apply GMP's in this world,
Breaking the GMP rules and why it is ok,
Protecting the patient,

11:30 AM 10 Minute Break

                How processes and products evolve,
How testing and specifications change,
Establishing an expiry date in an evolving world,
Locking down the product and process,
Transitioning from development into commercial world,
Where do companies go wrong so you do not have to,
Conclusions,

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
• Manufacturing Management and Scientists
• 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.