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ISPE Volunteer Week Spotlight: Publications, Regulatory Operations & Guidance Document

ISPE Volunteer week

COVID-19 pandemic has caused unprecedented change and disruption to each of our daily lives. All of us around the world are touched by the current pandemic, whether it be personal hardship or professional life challenges. We have seen our communities and our industry rally to work together for the good of public health and humanity. Our ISPE family is no different; several of our local Affiliates and Chapters have led efforts within their community or country to support responses to the impact of COVID-19.

Our network of Members and volunteers is being leveraged for tremendous positive impact in many places around the world. ISPE is celebrating our volunteers from 27 April - 1 May during ISPE Volunteer Week. Each day we will be spotlighting a group of ISPE volunteers highlighting the ways they are getting involved at ISPE to make an impact with the pharmaceutical and biopharmaceutical industry.

Pietro Perrone, PE
Sr. Process Engineer
Rentschler Biopharma, Inc.

Volunteer Role: Pharmaceutical Engineering Committee – Peer Reviewer

Pietro has been an ISPE member since 1997. One of the most active members of the Pharmaceutical Engineering Committee (PEC), Pietro is an active peer reviewer of manuscripts submitted to the magazine, is a regular attendee and participant in the PEC meetings and development of content ideas, and always pitches in when needed, even when the need is for extra reviews or participating as an AOTY judge. His contributions to the magazine make him a notable volunteer for ISPE!

Michelle M. Gonzalez, P.E.
Engineering Director (Retired) - AMGEN, Inc.
BioPharm Engineering Consultant

Volunteer Role: Pharmaceutical Engineering Committee – Peer Reviewer

Michelle has been an ISPE member since 1990. A long-time member of the Pharmaceutical Engineering Committee (PEC), Michelle has overseen the Article of the Year competition for the magazine for many years. She is also an active peer reviewer of manuscripts submitted to the magazine. Her devotion to quality and completeness in both endeavors makes her a standout volunteer for ISPE!

Tami J. Frederick
Senior Director, Corporate Quality Systems & Cultural Excellence

Volunteer Role: Chair of the ISPE Advancing Pharmaceutical Quality Initiative

Tami has been an ISPE member since 2015. During the past year Tami assumed the chairmanship of ISPE’s Advancing Pharmaceutical Quality (APQ) team, and in doing so allowed this team to seamlessly maintain its momentum and progress. This represents a significant investment of time as the APQ Team has long had a meeting schedule of 2+ meeting per week. Under her leadership, the first module of the APQ Quality Maturity Framework moved into the development phase and will be published before the end of 2020. Also in the past year, the APQ’s Quality Culture sub team collaborated with a team of PDA members to create a joint ISPE-PDA publication, the Guide to Improving Quality Culture in Pharmaceutical Manufacturing Facilities which was well received by CDER/OPQ leadership who consistently encourage organizations to collaborate and speak with one voice on behalf of and supporting the industry. While each organization had produced works on quality culture previously, by coming together to create a joint work that is seen as the logical next step in each organization’s quality portfolio they demonstrated to regulators the organizations’ willingness to work together for the good of the industry and the patients we serve.

Jose A. Caraballo
VP Quality Systems, Compliance, and Quality Engineering
Kite Pharma, Inc.

Volunteer Roles: Chapter Lead, Good Practice Guide: Technology Transfer; Co-Lead, Good Practice Guide: Cleaning Validation; Team Member, Guidance Document Committee

Jose Caraballo has been an ISPE member since 2003. For the past 7 years, he has been an active participant on the Guidance Document Committee and has been instrumental in helping bring several Guides to publication. He started working first-hand on Guides as a Chapter Lead for the Good Practice Guide: Technology Transfer. Once that Guide was complete, Jose volunteered to help author the Good Practice Guide: Cleaning Validation, which is scheduled to be published this June. When one of the original Co-Leads had to step down, Jose did not hesitate when asked to take over the role. As Co-Lead for the team, Jose has been instrumental in keeping the team members engaged and focused while addressing the numerous comments received during industry review. He values everyone's opinions and contributions and has helped keep the team on track to meet the publication deadline.

Jose is a biotech/biopharma executive with extensive drug substance and drug product manufacturing and operations expertise. His current responsibilities include leading all quality aspects for the new Cell Culture Technology Center at Bayer, in Berkeley, CA. His experience includes MSAT, Quality Operations, Process Optimization, Manufacturing Operations, Technology Transfers, Facility Start-ups, Supplier Quality Management, Validation, and Regularity Submissions from multiple roles in development, quality, and manufacturing at Abbott Laboratories, Amgen, and Bayer.

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