Todd Philipps

Todd Philipps Email and Phone Number

Director Of Operations at Reliable High Performance Products @ Reliable High Performance Products, Inc.
123 Easy Street, Carol Stream,IL 60188,United States
Todd Philipps's Location
Winfield, Illinois, United States, United States
About Todd Philipps

Todd Philipps is a Director Of Operations at Reliable High Performance Products at Reliable High Performance Products, Inc.. He possess expertise in regulatory affairs, fda, validation, pharmaceutical industry, ectd and 37 more skills. Colleagues describe him as "I've had the pleasure of working with Todd over the past year. We collaborated on my first major validation project at Anchen. Todd is the system owner for an eCTD application. Todd and I worked very closely together to create, execute and obtain approval for the entire collection of validation deliverables which resulted in the on-time QA release of the validated system. This enabled the Regulatory Affairs group to successfully submit eCTD applications to the FDA electronic gateway. Todd is an open minded team player with exceptional knowledge of Regulatory Affairs and associated software used in that area. I highly recommend him." and "I have worked with Todd in a cross functional team manner for the filing of Abbreviated New Drug Applications (ANDAs). Todd has been instrumental in facilitating, coordinating and gathering comments from team members in initiating a broad based submissions procedure for filing of ANDAs. He also has worked with my team members in my Biopharmaceutics department on the facilitation of Modules 2.5, 2.7 and 5 for these filings to FDA. He helped to streamline the process of getting final documents from our department to his department for submission processing. Todd is a knowledgeable and a very well-informed and resourceful person who not only knows the submissions processing procedures and regulations, but also seeks out to provide the impact of the procedures and regulations to our team members. In addition to being knowledgeable, Todd is also flexible and patient. It is often difficult to communicate the technology behind the electronic filing regulations and requirements to a broad team. Todd’s communication skills allow him to break-down complex regulations into simple, understandable terms to the team members. Additionally, I have always appreciated Todd’s flexibility when working alongside him on projects. I feel that Todd’s skill set and personality would be a great asset to any organization. He would foster a great learning environment and will get the job done in a timely matter."

Todd Philipps's Current Company Details
Reliable High Performance Products, Inc.

Reliable High Performance Products, Inc.

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Director Of Operations at Reliable High Performance Products
123 Easy Street, Carol Stream,IL 60188,United States
Website:
shopreliable.com
Employees:
10
Todd Philipps Work Experience Details
  • Reliable High Performance Products, Inc.
    Director Of Operations
    Reliable High Performance Products, Inc. Aug 2018 - Present
    Greater Chicago Area
  • The Anvil Group
    Founder
    The Anvil Group Jan 1995 - Present
    eSubmissions consulting company focused on electronic Isubmissions to FDA.Main expertise entails eCTD publishing, buisness process development, SPL & XML generation.
  • Par Pharmaceutical (Formerly Anchen Pharmaceuticals, Inc.)
    Regulatory Affairs Associate Iii
    Par Pharmaceutical (Formerly Anchen Pharmaceuticals, Inc.) Oct 2010 - Jun 2013
    Irivne, Ca
    • Lead implementation of MedXview eCTD software. Transitioned from paper submission environment to fully GxP validated eCTD environment within 6 months of project start.• Responsible for all eCTD publishing, submission, archival and regulatory information activities.• Developed Regulatory Operations role. Established eSubmission processes, archival processes and regulatory information management, eSubmission and SPL SME roles.• Digitized complete paper library providing Anchen employees and off-site partners access to all submission documents from their desktop. Converted 415 paper volumes to 18 gigabyte of online data.• Structured Product Labeling (SPL) subject matter expert including SPL for draft labeling submissions, drug listings, content of labeling and establishment registration.• Implemented TVT tool suite to aid document reviews and comparisons. Saving an average of 8 hours review time per comparison with an average of 4 comparisons per labeling submission. Also providing 99.9% accuracy.• Developed submission and product tracking database providing central repository for all regulatory product related and submission related information.• Developed materials usage database to aid regulatory associates in tracking raw materials used in production of final products as well as tracking authorized labs to test raw materials and final products.
  • Image Solutions, Inc.
    Regulatory Consultant
    Image Solutions, Inc. Feb 2009 - Oct 2010
    West Coast
    • Develop Best Practice, Insider Tips & How-to documents for use on ISI’s support portal ISIOnCall• Provide business process and best practice recommendations regarding eCTD/CTD dossiers to ISI clients • Provide clients with Regulatory guidance interpretations, flexibilities, and requirements • Write custom work instruction documents on a client-by-client basis to include business process, software processes and regulatory information• Conduct Business process workshops to enable customers to develop/refine business processes as they relate to Electronic Submissions• Provide software specific training to customers for ISI such as: Introduction to eCTD, ISIWriter, eCTDXPress, ISIPublisher, Technical Administration• Provide guidance and implementation to clients when transitioning from paper submissions to electronic• Software implementation project management responsibilities for ISI clients• Provide staff augmentation for various Regulatory and IT positions
  • Watson Laboratories, Inc.
    Regulatory Associate Iii
    Watson Laboratories, Inc. Jul 2007 - Feb 2009
    • Business lead for Corporate-wide Electronic Submission (eCTD) software implementation. Cost savings of over $560,000/year for Corona Site.• Defined user requirements, user acceptance testing procedures and SOPs for eCTD and Electronic Submission Gateway (ESG) systems.• Developed and conducted software training covering all aspects of new software systems. Personally trained approximately 75 people.• Defined and published Business Practice guidelines covering both Pre-Approval submissions and Post-Approval Submissions• Subject Matter Expert supporting 4 corporate sites across the US.• Managing integration of off-shore eCTD submissions into corporate systems.• Work with a team of 3 to compile and publish 30 ANDAs and approximately 200 amendment/supplements per year, Corona Site.
  • Watson Pharmaceuticals
    Associate Iii, Regulatory Affairs, Operations
    Watson Pharmaceuticals 2007 - 2009
  • Relsys
    Configuration / Engineering Manager
    Relsys 2002 - 2007
    • Manage Quality Assurance server / environment administration and product delivery functions providing stable and reusable environments for testing.• Manage 10 servers including Web and Database servers for product validation and issue verification activities.• Extensive experience in SDLC including gather customer requirements, investigating customer business scenarios, writing requirements, actual development, QA activities and onsite customer installations.• Managed development efforts between USA and India Office, including offshore team of 8 engineers with local team of QA, Database and Marketing.• Delivered initial Reporting Product in 7 months, after existing team labored 2 years with no success.
  • Relsys International, Inc.
    Configuration / Engineering Manager
    Relsys International, Inc. 2002 - 2007
  • Consumerinfo.Com
    Engineering Team Leader
    Consumerinfo.Com Aug 1999 - Nov 2002
    • Teamed with marketing department to define requirements, design and scope of projects.• Managed 12 team members on multiple tasks across multiple projects.• Maintained and supported ecommerce websites and servers, averaging over 10 million unique visitors per month and 75,000 orders per week.• Successfully integrated 3rd party tools into websites through collaborative efforts with vendors, credit card clearing and home sales data.• Managed new development, maintenance, server administration and database administration.• Converted all company sites from Perl & FoxPro to ASP & SQL Server 7.0.
  • Iowa State University
    Systems Analyst Iii/Web Developer
    Iowa State University Aug 1988 - Aug 1999
    • Developed and provided support for ISU’s AccessPlus, an interactive Student Information System available via web browser or campus Kiosks that averages 165,000 hits per month• Worked as webmaster for ISU dealing with problem resolutions, upgrades and client support.• Developed, implemented and maintained batch programs in support of numerous CICS systems, using CA-Easytrieve and COBOL• Conducted systems analysis, design and programming with MVS computer systems supporting ISU’s Human Resources Department

Todd Philipps Skills

Regulatory Affairs Fda Validation Pharmaceutical Industry Ectd Regulatory Submissions Anda Gmp Document Management Databases Sdlc Isi Toolbox Microsoft Sql Server Andas Regulatory Requirements End User Training Regulatory Operations Process Simulation Spl Ectdxpress Isi Publisher Drug Product Medxview Ecentral Medxview Elabel Sql Server Javascript Records Management Process Development Asp Text Verification Tool Labeling Spl Drug Listing Spl Xforms Php Mysql Filemaker Pro Establishment Registration Spl Global Submit Webtrader Isiwriter Aca 6004 Nees

Todd Philipps Education Details

Frequently Asked Questions about Todd Philipps

What company does Todd Philipps work for?

Todd Philipps works for Reliable High Performance Products, Inc.

What is Todd Philipps's role at the current company?

Todd Philipps's current role is Director Of Operations at Reliable High Performance Products.

What is Todd Philipps's email address?

Todd Philipps's email address is to****@****ons.com

What is Todd Philipps's direct phone number?

Todd Philipps's direct phone number is +195154*****

What schools did Todd Philipps attend?

Todd Philipps attended University Of Northern Iowa, Ldf.

What skills is Todd Philipps known for?

Todd Philipps has skills like Regulatory Affairs, Fda, Validation, Pharmaceutical Industry, Ectd, Regulatory Submissions, Anda, Gmp, Document Management, Databases, Sdlc, Isi Toolbox.

Who are Todd Philipps's colleagues?

Todd Philipps's colleagues are Courtney Budler, Sean Houston, Jeremy Mcdowell, Gregg Rosenboom, Paul Hunt, Greg Parsons.

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