Eric Berg

Mr Eric Berg, Director of Supplier Quality, Amgen Mr. Berg has been with Amgen since 1992 and has worked in manufacturing, operations project management, and quality administration. For four years he has led Supplier Quality, a group that is responsible for managing the quality aspects of Amgen's raw material suppliers. In order to continue to advance Supplier Quality at Amgen and within the Pharmaceutical industry, he actively participates in industry wide focus groups, PDA, and other relevant trade organizations. Mr. Berg holds a Bachelor of Science degree in Biology from California Lutheran University.
...
Eric Berg Director of Supplier Quality

Eric L. Berg, Associate Director, Supplier Quality, Amgen Inc.

Eric L. Berg, Associate Director, Supplier Quality, Amgen Inc.
...
Eric L. Berg, Associate Director, Supplier Quality, Amgen Inc.

Eric Berg
...
Eric Berg, Director of Supplier Quality, Amgen, Inc.

Eric Berg, Director of Supplier Quality, Amgen, Inc.
...
Eric Berg, Director of Supplier Quality, Amgen, Inc.

Eric Berg Director of Supplier Quality

Eric Berg Director of Supplier Quality

Eric Berg, Director of Supplier Quality, Amgen, Inc.

Eric Berg, Director, Supplier Quality, Amgen, launched directly into the heart of topic by asking the audience rhetorically: “A fundamental question is how do we make the problem of glass breakage go away?†He offered two “simple†solutions: “One, acknowledge that it is a problem and two, drive an action to make it go away.â€

In reality, there are no simple solutions. Berg noted that there has been some reconsideration of glass as a primary packaging material. “I think it is something for us to look at,†he said.

As to why industry should pursue a zerodefect approach, Berg asked attendees to put themselves into the mindset of a consumer safety officer: “A consumer safety officer perspective might be that not one defect should make it into the hands of patients.†Even if a glass defect did not prevent a patient from using a prefilled syringe product, the consumer safety officer might see other problems, including microbial contamination.
...
In the end, Berg agreed with the regulatory view about zero defects: “I would give my advocacy that we look at glass holistically, that we seek as an industry to work jointly with suppliers, that we see glass breakage as a problem, that we need to have a sense of urgency to drive solutions and see zero defects as a target. I think that that is key.†Just as an airplane traveler would not accept “six sigma,†demanding perfection upon every plane, a patient demands perfection, also.

Berg challenged the audience to consider what might be done to achieve zero defects and to think hard about alternatives to glass.

Berg found a partisan in Justin Wright, PhD, Manager, Bio-Analytical and Pharmaceutical Sciences, BD Medical, who stated, “Continuous improvement is not good enough anymore.†During his presentation, called “Next Generation Automated PFS Production: A Holistic Approach to Quality by Design,†Wright touted the use of sound design strategies to prevent defects.