Raw materials and components management. Latest FDA and EMA regulatory requirements including a review of the EMA falsified medicines directive, FDA safety and integrity act, drug supply chain security act , and secure supply chain pilot program.
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Peter Calcott Ph.D. Biography>>>
Available Live On-Demand
Over the last ten years we have seen the landscape of the supply chain changing. Gone are the days when we only focused on the materials and product in the warehouse. Gone are the days when you could rely on the label on the product. Counterfeit drugs are out there and it’s a growing problem. Even your raw materials and components that you relied upon are no longer assured. Foreign and domestic manufacturers are running afoul of the regulations. You can either wait for disaster to strike, or be proactive and assure it will never happen.
The regulators (FDA and EMA) have taken the bull by the horns and developed guidances, regulations and acts to guide you as you set up your systems. The approach is different but complementary. The progressive company learns from both and develops a strategy to assure that the product they make is assured and arrives in top condition at the patient.
We will cover the elements of assurance of the supply of raw materials and components and how the Europeans have approached it. When you make the product we will focus on how you can be assured that it arrives in the condition intended. This includes assuring the distribution network is secure and meets the product storage conditions. Managing third party manufacturers will be a key point so you can add confidence in your suppliers.
In this live webinar we will walk through all the new regulations and what is contemplated in the future with details on what must be done and when. We will include best practices to investigate and correct issues discovered in your systems.
-Where your supply chain is vulnerable and what to do about.
-What the latest challenges are and what the agencies are expecting you to do.
-The requirements of the EMA Falsified Medicines Directive and when the elements must be implemented.
-The requirements of the FDA Acts that have been recently passed including Food and Drug Administration Safety and Integrity Act (FDAsia), Drug Supply Chain Security Act (DSCSA), & Secure Supply Chain Pilot Program (SSCPP).
-How to prioritize what is the most critical and must be acted upon and what you can postpone.
Webinar outline and time breakdown:Time*
|10:15 AM||Log In Period|
|10:40 AM||What is the supply Chain and modern Materials Management,|
|Where are the vulnerable steps,|
|What is the FDA and Canada proposing,|
|What do the Europeans want,|
|Harmonization of the two,|
|What to focus on,|
|11:40 AM||Building security in your raw materials,|
|Protecting the bulk substance and drug product in shipment,|
|Counterfeiting and the internet,|
|Working with the regulators,|
|12:30 PM||Live 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 participation for attendee training records
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Quality Assurance personnel
- Quality Control personnel
- Research & Development
- Regulatory Affairs Professionals
Instructor: Peter Calcott Ph.D.
Peter H. Calcott, Ph.D. is President, Calcott Consulting which is focused on delivering solutions to pharmaceutical and biotechnology companies in the areas of corporate strategy, supply chain, quality, clinical development, regulatory affairs, corporate compliance and enterprise e-solutions. He is also an Academic Program Developer for the University of California, Berkeley’s Biotechnology and Pharmaceutics Postgraduate Programs. Prior to this he was VP at the executive team level at PDL BioPharma where he was responsible for development and implementation of Quality & Compliance strategy across the corporation… Full Bio>>>
All Pharma Webinars live training programs audio and visual are delivered via Cisco WebEx with basic system requirements of a computer with internet access and a telephone to access the audio portion of the presentations. You can choose to access the audio through your computer.
Live Training Benefits:
Live Training Benefits:
• Pharma Webinars training webinars and programs are presented exclusively as live events only.
• Designed and delivered based on e-learning best practices, Pharma Webinars' live training webinars and programs are as effective as in person training.
• Live training webinars and multi-part training programs are strictly educational based, and do not promote or endorse any products or services whatsoever.
• An interactive live Q&A and discussion period is included in each live training presentation. Questions can also be submitted to the speaker via email both prior to and following the live training webinar as a means of improving participant experience, and ensuring successful topic comprehension.
• Live presentations ensure that all live training webinars and programs are engaging and informative, allowing trainees to exchange ideas through audio conferencing and live chat during each presentation in real time. Each live training session includes a dedicated live Q&A period allowing trainees to interact directly with the instructor, with quick feedback providing them with concrete understanding of the answers and the training subject itself.
• Each Pharma Webinars live training webinar and program content is updated on regular basis to provide the latest regulatory, operational and technological trends in the international pharmaceutical arena. As regulatory expectations, guidance, or industry trends change, so does our training in order to reflect those changes as soon as the changes are released.
• Pharma Webinars' instructors are the most recognized subject matter experts in the industry who are selected based on very strict qualification criteria. They are coached on the latest e-learning speaking methods in order to make each presentation engaging, memorable and very effective.
• Each registered attendee receives an exact copy of the presentation slides and other course handouts significantly reducing the learning curve as trainees can refer back to this material in the future.
• All trainees receive a Certificate of Attendance for each live training webinar and program they attend to be kept for training records.