Latest FDA EMA & Other Regulatory Requirements of Pharmaceutical Manufacturing; from Manufacturing of Bulk Drugs to Finished Product Including Packaging and Labeling Activities
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Peter Calcott Ph.D. Biography>>>
Available Live On-Demand
This instructor-led live training webinar will focus on the areas of production from manufacture of bulk drugs all the way to finished product including the packaging and labeling activities. While these areas are characterized by an incredibly diverse set of operations encompassing a wide range of products and actives from very low molecular weight products such as water for injection and aspirin (MW 18 and 168) to large molecules such as Factor VIII (MW 400,000+), many of the challenges for GMP are very similar although the solutions to them may be different. In all cases GMP focuses on assuring we start out with the right materials, manufacture according to defined procedures and controls, and end up with a product that meets the patients’ requirements. This is described in ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) and Q10 (Pharmaceutical Quality Systems). During these steps, we attempt to prevent contamination from the environment and other manufacturing steps and prevent product degradation.
In this live training webinar, we will describe the basic principles used to prevent contamination, degradation and assure control of our processes, and hence products. We will walk through the major steps in the process (bulk and drug product manufacture, and packaging and labeling steps) to explain the driving force and intentions of the GMPs to that end. While commercial operations require strict adherences to the GMP to assure consistency and control, we will describe how clinical manufacturing requires more flexibility to allow development to progress as we learn more about the product and process. We will describe how a modern approach to development (Quality by Design) can be an advantage to the ultimate commercial operations with the intelligent use of ICH Q8 (Pharmaceutical Development) and 11 (Development and Manufacture of Drug Substances). With the intelligent use of ICHQ9 (Quality Risk Management) and efficient Knowledge Management we will describe how processes can be transferred effectively setting the stage for process validation and continuous verification.
-The expectations of the FDA and EMA and other regulatory bodies with respect to control of pharmaceutical manufacturing and packaging.
-How to develop and transfer technology from development to commercial operations effectively.
-What the GMPs really mean and why they say what they say.
-Why such different systems and technologies have such similar challenges to deliver a safe and efficacious product to the patient.
-What the challenges are in your operations and how to address them satisfactorily.
-Where companies fail to deliver a compliant operation putting their business and compliance reputation at risk .
Webinar outline and time breakdown:Time*
|10:15 AM||Log In Period|
|10:40 AM||The different operations, all with the same challenges,|
|What are the GMP challenges?|
|How the challenges are met in different cases,|
|GMPs in development versus commercial – how they are different,|
|Flexibility in clinical operations,|
|Caution in commercial operations,|
|11:40 AM||Linking development to commercial and knowledge transfer,|
|Specific challenges in bulk manufacture,|
|Challenges in drug product,|
|Packaging and labeling,|
|Where companies fail to deliver,|
|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>>>
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