Navigation Links
Julia O’Neill of Tunnell Consulting Shares Process Validation Insights at Pharma Conference
Date:5/15/2017

Tunnell Consulting announced that Julia O’Neill, principal and statistician, will be sharing her insights in a presentation of “The Key Role of Specifications in Process Validation,” at the Process Validation Summit 2017, May 18 and 19, at the Racquet Club of Philadelphia. The event will bring together leaders from the pharmaceutical and biotech industries to explore processes, strategies and new approaches to ensuring that they meet or exceed regulatory expectations and avoid costly FDA delays.

O’Neill also recently presented at the Regulatory Sciences for Biologics and Vaccines Conference in Leesburg, Virginia, which focused on accelerating and enabling manufacturing innovation. During that conference, which was held in April, the subject of O’Neill’s presentation was “Lifecycle approach to validation supports accelerated approvals.” She also took part in a panel discussion in April’s Outsourced Pharma event in Boston, where she moderated discussions of “Winning workforce: A new generation in the supply chain.” and “FDA, regulatory, and quality dynamics for innovative outsourcing.”

As regulators require ongoing monitoring of processes throughout a drug product’s lifecycle, pharmaceutical companies must modernize their validation and risk management approaches. This event will cover these issues, along with discussions of global technology transfer, process validation lifecycle management, and how the Drug Supply Chain Security Act relates to validation.

O’Neill’s presentation explores alternative approaches for specification setting, and recommends specific strategies for both traditional and accelerated validation. “I am looking forward to attending this important industry event,” said O’Neill. “It is especially vital for members of the industry to ensure they are compliant with the latest FDA requirements for validation.” During her presentation, O’Neill will discuss the challenges of gaining information about true product requirements, and the challenges involved in breakthrough or orphan drugs, where data may be limited.

O’Neill is a CMC statistician with over 30 years of experience bridging statistics and chemical engineering, applied to a broad range of challenges in vaccines, biologics, pharmaceutical and chemical development and manufacturing. Prior to joining Tunnell, she was responsible for development and deployment of process robustness strategy for manufacturing at Merck. She is an expert at resolving challenging problems using statistical, engineering, and Six Sigma methods.

About Tunnell Consulting

Founded in 1962 and serving many of the world’s leading life sciences firms and government agencies, Tunnell Consulting, Inc. integrates strategic, technical, process, and organizational skills to design and implement sustainable solutions that exactly meet client needs. With deep industry knowledge, extensive scientific credentials, and superior measurable results, we consistently boost the operating performance of each unique client we serve. To learn more, visit us online at http://www.tunnellconsulting.com.

Read the full story at http://www.prweb.com/releases/2017/05/prweb14333137.htm.


'/>"/>
Source: PRWeb
Copyright©2017 Vocus, Inc.
All rights reserved


Related biology technology :

1. Julia O’Neill Joins Tunnell Consulting’s Operational and Process Improvement Practice
2. Frédéric Lefebvre Joins Tunnell Consulting as Director Focused on Business Development in Europe
3. Dr. Walter Matzmorr Joins Tunnell Consulting
4. Gerard (Jerry) Guillorn Joins Tunnell Consulting As Group Vice President, Business Development
5. Tunnell Consulting Partners with Dr. Ajaz Hussain on Solutions for Life Sciences Product Development, Quality Assurance and Regulatory Compliance
6. Anthony A. Charity Joins Tunnell Consulting
7. Tunnell Consulting Names John S. Ross as Principal, Life Sciences
8. Trust Transparency Consulting Launches Ingredient Trade Association Incubator Program
9. Astrix Joins BIOVIA Consulting Partner Program
10. Biotech Sector Influencing Growth in the Pharmaceutical Consulting Services
11. Pharma and Biotechnology Consulting Firm Announces European Director
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... USA (PRWEB) , ... October 11, 2017 , ... ComplianceOnline’s ... take place on 7th and 8th June 2018 in San Francisco, CA. The Summit ... as well as several distinguished CEOs, board directors and government officials from around the ...
(Date:10/11/2017)... the Netherlands and LAGUNA HILLS, Calif. ... The Institute of Cancer Research, London ... use MMprofiler™ with SKY92, SkylineDx,s prognostic tool to risk-stratify patients ... trial known as MUK nine . The University of ... trial, which is partly funded by Myeloma UK, and ICR ...
(Date:10/11/2017)... Florida (PRWEB) , ... October 11, 2017 , ... ... Drug Administration (FDA) has granted orphan drug designation to SBT-100, its novel anti-STAT3 ... for the treatment of osteosarcoma. SBT-100 is able to cross the cell membrane ...
(Date:10/10/2017)... ... October 10, 2017 , ... For the second time ... US2020 STEM Mentoring Award. Representatives of the FirstHand program travelled to Washington, D.C. ... US2020. , US2020’s mission is to change the trajectory of STEM education in ...
Breaking Biology Technology:
(Date:4/13/2017)... MONICA, Calif. , April 13, 2017 ... New York will feature emerging and evolving ... Summits. Both Innovation Summits will run alongside the expo ... of speaker sessions, panels and demonstrations focused on trending ... coast,s largest advanced design and manufacturing event will take ...
(Date:4/11/2017)... April 11, 2017 NXT-ID, Inc. (NASDAQ: ... company, announces the appointment of independent Directors Mr. Robin ... its Board of Directors, furthering the company,s corporate governance and ... Gino Pereira ... look forward to their guidance and benefiting from their considerable ...
(Date:4/4/2017)... --  EyeLock LLC , a leader of iris-based identity ... and Trademark Office (USPTO) has issued U.S. Patent No. ... iris image with a face image acquired in sequence ... th issued patent. "The issuance ... multi-modal biometric capabilities that have recently come to market ...
Breaking Biology News(10 mins):