linked in

Title Published
Assuring Product Quality Vision Systems and In-Line Weight Sort

Join the discussion on product quality and vision systems, what's new, what are the challenges, flexibility and mechanical systems to improve what humans cannot do with industry expert, Tim Kramm, Vice President and General Manager, Rommelag, USA.

Business Strategy Manufacturing Flexibility and Versatility

Achieving manufacturing flexibility and versatility while considering real-life examples with industry expert, Sébastien Ribault, PhD, Director Provantage Biodevelopment/End to End Delivery Process Solution, Merck Millipore

FDA Fast-Track Approval or is it Quality By Design?

QbD Expert, Russ Somma, PhD, SommaTech Consulting, offers his insight on how fast-track and QbD intertwine and how it is actually a business practice that, once adopted, can accelerate your time to market.

How to Protect your IP in a CMO Environment

This discussion centers around the combination of legal experience and years of academic research in chemistry to develop intellectual property strategies that protect both established and fledgling businesses. Learn from experts David E. Wigley, Ph.D., Partner, and William L. Warren, Partner, both from the firm of Sutherland Asbill & Brennan LLP.

Implementing a Risk-based Approach: What Does your Analysis Look Like?

Joel Russo, MS, CQA discusses adherence to quality practices and the risk-based approach to regulatory compliance.

Modularity and Portability of the Cleanroom

This priominant and timley topic offers insight into the identification of moving processes and the abiltiy biomanufacture products, including biosimilars, just about anywhere in the world. Learn from Craig Johnson, Technical Sales Engineer, Walker Barrier.

What Happens When I Want to Produce a Potent Compound

Anything that you ever wanted to know from what is potent to the how to manufacture potent pharma/bio products while protecting both product and operators with industry expert, Les Edwards, Director, Eastern Region, SKAN.

Business Strategy: Continuous Manufacturing and Hybrid Systems

The advantages, challenges and review of opportunities presented by continuous manufacturing and hybrid systems with industry experts Felix Martinez, Process Architect, Bristol-Myers Squibb and Tim Remmert, Executive Director, LB Bohle GmbH.

Hosted by Russ Somma, PhD, SommaTech Consulting.

Computer System Validation for the Rest of Us

As regulatory agencies talk with the life science communities, computer system validation becomes even more important. just how important it is life sciences? Learn from CSV expert, Aaron Weinstein, Senior Director & Principal, IPS-Integrated Project Services.

Engineering a Pharma Product Using Drug Development Knowledge
Chuck Stock CxA, IPS Russ Somma, PhD, SommaTech

Facility of the Future Will Not Necessarily be a Facility

Many experts predict the facility of the future will "not be a facility". Join experts McCoy Knight, National Sales Manager, GEA Process; Clark H. Byrum, Jr,, President/CEO, Biologics Modular and Craig Walker, Technical Sales Engineer, Walker Barrier for their take on this topic.

Hosted by Russ Somma, PhD, SommaTech Consulting.

How to Prepare for an Auditor or an Inspection

As a drug or medical device manufacturer, your facility will be inspected by the U.S. FDA, learn more with expert Dina Mianes.

Implementing New Packaging Integrity Testing Guidelines

Discussion regarding all aspects of leak testing as directed by the United State Pharmacopeia General Chapter 1207, including key issues such as method selection, method development and method validation. Expert Panel includes. Justine Young, Project Manager for Container Testing Services, Whitehouse Labs; Jim Veale, President, Lighthouse; Oliver Stauffer, COO, PTI and Don Singer, Group Lead Quality Manager, GSK.

INTERPHEX 2013 wtih PharmaEvolution
Russ Somma, PhD

Leveraging QbD as a CMO Market Strategy for Client Success

Call it Quality by Design, call it good development, it has to be leveraged in putting together a sourcing strategy. Learn more about applying QbD principles as a market strategy for CMO sourcing for industry expert, Kay Schmidt, R&D VP, Advanced Delivery Technologies, Catalent Pharma Solutions.

Hosted by Russ Somma, PhD, SommaTech Consulting.