GMP/GLP/GCP IT, Network support

GMP/GLP/GCP IT, Network support

GMP/GLP/GCP IT, Network supportGMP/GLP/GCP IT, Network supportGMP/GLP/GCP IT, Network support

Biotechnology, Pharmaceutical  

Drug & Device Development, Manufacture, Testing, Clinical  Trials

QUALITY, REGULATORY COMPLIANCE, CMC

Consulting about Healthcare and Life Science Industries

Experience and knowledge

Quality oversight of contract manufacture and testing

Quality Systems, Regulatory Compliance

  • Over 30 years USA, European, UK experience pharma & biotech GMP manufacture, testing
  • Hands on product development
  • Helena was Quality Director at Pfizer (Wyeth Biotech), held senior positions at Biogen Idec, Genzyme, Millipore, Cambridge Isotope Labs /Otsuka
  • Wide QA, Regulatory Compliance  experience drugs, medical devices
  • Helena has Masters in Science, University of Guelph, Ontario, Canada, research, thesis development HPLC methods peptides separation
  • Bachelors in Chemistry, Biology
  • MBA Northeastern University Boston
  • Worked on many Clinical development programs to commercial launch, support commercial products

  

  • IT, Network support by experienced associate

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Quality Systems, Regulatory Compliance

Quality oversight of contract manufacture and testing

Quality Systems, Regulatory Compliance

  • Lead GMP, GLP, GCP Audits
  • FDA/ European/ global regulations
  • GMP, GLP, GCP 
  • Have led over 80 Audits worldwide
  • Active Pharmaceutical Ingredients (API) 
  • Drug Products
  • Quality Agreements
  • Quality Systems
  • Standard Operating Procedures / SOPs
  • Risk Assessment
  • Training 
  • Pre-Approval Inspection prepare
  • Inspection and Warning Letter Response and follow up.
  • Consent Decree remediation
  • Management controls, internal audits and performance metrics
  • Meet new FDA and ICH expectations for management responsibility 

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Quality oversight of contract manufacture and testing

Quality oversight of contract manufacture and testing

Quality oversight of contract manufacture and testing

  • Batch Record Review, Batch Release  
  • Investigations, Corrective Action and Preventive Action
  • Technology Transfer
  • Master Batch Record development, Device History Record, procedures
  • Master Validation Plans, Process Validation Protocols /Reports, Equipment Qualification
  • Test Method Validation
  • Analytical Method Review
  • Supplier qualification, Supply Chain Quality
  • Expert on water systems
  • Clinical diagnostic reagents 
  • Chemistry, Manufacturing Controls (CMC) review
  • Hope is not a Supplier Qualification Strategy, Contract Pharma, October 2011 http://www.contractpharma.com/issues/2011-10/view_features/supply-chain-focus-global-quality-issues/ 

  


INFORMATION TECHNOLOGY, COMPUTER SERVICES AVAILABLE 

Laptop, Tablet, printer, Setup, Network Support.
• PC/ Tablet Setup
• Printer, Scanner Setup
• Software Installation and updates
• Image, setup and deploy Mac / PC computers to users
• Operating System Installation
• Troubleshoot Internet connectivity issues
• IT support
• Android phone familiarization, help
• Troubleshoot, diagnose and solve issues Mac/ PC systems
• Diagnose and Repair
• Server Administration
• Server Diagnostics and Repair
• Teach how to use devices, software

Pharmaceutical, Biotechnology, Medical Device GMP GLP Expert

Contact us

SEE BROCHURE at: http://chemconsultants.org/resources/Documents/Helena%20Champion%20DQA%20LLC.pdf

ARTICLES BY HELENA:

Ensuring Drug Quality in a Global Economy, Contract Pharma May 2014

http://www.contractpharma.com/issues/2014-05-02/view_features/ensuring-drug-quality-in-a-global-economy/

NE Parenteral Drug Assoc speaker March 2013 "Pharmaceutical Supplier Quality for the 21st Century" 

How to Overcome Industry Challenges of More Required Audits, IVT 3rd Supplier Quality Forum Nov 2012 Philadelphia PA

Keynote speaker Informa Biopharmaceutical Raw Materials Conference June 2012, Cologne, German

Drug Quality Assurance, LLC,

drugqualityassurance@gmail.com

781-724-6812

Boston, MA and Palm Beach, FL

  • Small molecule synthesis, cell culture, fermentation, biotechnology, biologics and vaccines 
  • Drug product - aseptic processing, parenterals, transdermal 
  • Oral liquid, tablet, inhaled dosage forms and packaging

http://www.chemconsultants.org/Sys/PublicProfile/10969484/1641396