Conference Sessions

Since 1973, studies of adult learners have revealed a number of important items relevant to training – especially training for Regulatory Compliance and training on Standard Operating Procedures  Read More »

Definition of Biopharmaceutical Manufacturing The manufacturing of biomaterials proteins, monoclonal antibodies, plasmid DNA, viral products or other biologics from microbial or mammalian cells, or transgenics production methods for therapeutics, diagnostics and vaccines.  Read More »

• Provide overview of global industry challenges and impact on pharmaceutical manufacturing • Brief summary of Pfizer and Pfizer Global Supply (PGS) • Highlight critical need for active linkage between global supply network elements • Importance of a strong quality culture  Read More »

Dramatic Increase in Demand for Outsourcing Poor Global Economic Conditions and Sputtering R&D Engine – Rising R&D cost and volume; constrained revenue growth – Downsizing/Consolidation – Inefficient and costly operations  Read More »

You read a new article that your CMO / CDMO has declared bankruptcy or is exiting the business for one reason or another!  Read More »

Developing the Corporate Manufacturing Strategy 1.Evaluating the make vs. buy decision 2.How much of the supply chain should be outsourced? 3.What is the expected outcome of outsourcing? … Begin with the End in Mind. 4.The manufacturing strategy should be in the transferring company’s Business Plan. The manufacturing strategy can make or break your company  Read More »

Manufacturing is strategic Manufacturing is a core competency  Bio/pharma is a product business  IP is only a means to an end  Manufacturing is critical to business success  Read More »

To become a World Class Specialty Pharmaceutical Company that develops and commercializes proprietary formulations of the most commonly prescribed anesthesiology products in order to reduce medication errors.  Read More »

3 Objectives •Identify significant trends in Inspectional Observations –Identify Trends across the Agency, both foreign and domestic –Identify Trends within New Jersey District •Provide Examples  Read More »

A foundation of active alliance execution including the strategic influence of decision-making processes enhanced by heavy problem-solving involvement, enables alliance professionals to contribute to the overall value of their organizations.  Read More »

“Rx-360s current members are pioneers that are building the type of global, all embracing industry group of the 21st century. Rx-360 is working to ensure that patients everywhere can enjoy the benefits of globalization safely.”  Read More »