Journal of Developing Drugs
Open Access

2^nd International Summit on GMP, GCP & Quality Control

November 12-14, 2013 DoubleTree by Hilton Hotel Chicago-North Shore, IL, USA

Scientific Tracks Abstracts

• Maintaining your laboratory in a state of control - The data integrity challenge

  Jacqueline McCulloch and Courtney Woodson

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• Case study: Quality assurance and quality control partnering to drive compliance, science, and innovation

  Jason Ruckert

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• Quality assurance on a budget: A non commercial perspective

  Lucy H. H. Parker

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• Automation in validated environments

  Abitha Sundararajan

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• Quality accreditation for medical research at Universities

  Brigitte Von Rechenberg

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• Risk assessment

  M. S. Lourdes Sánchez

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• Modern quality systems & risk management approaches

  Naveen Kumar Venkatesham

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• Diverting from traditional validation approaches - Beefing up and speeding up validation, while minimizing vulnerabilities to new regulatory inspection foci

  Constance E. Curts

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• Data integrity issues

  Mohammad Iqbal Hossain

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• Challenges in benefit-risk evaluations during co-development among partnerships and alliances

  Ashraf Youssef

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• Is your company in a state of control?

  Brian Hill

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• Prior knowledge assessments: A knowledge compilation process that can be used to bring about more focused process characterization and development studies for platform products

  Jim Seely

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• Mitigating the environmental impact of cleaning processes in GMP regulated facilities

  Elizabeth Rivera

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• The role of “c” in cGMP

  Naveen Kumar Venkatesham

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• The evolution of the medical device 510 (k) process and impending changes

  Jacqueline McCulloch

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• Supplier management - Key components of managing suppliers in a cGMP environment

  Pejman Parhami

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• Bridging the cultural divide: Supplier auditing in a global economy

  Jennifer Leny

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• A risk based scientific approach to analytical method development and validation activities for regulated laboratories

  Shib Mookhaerjea

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• Moving beyond Part 11; Quality assurance considerations for translating cGMP compliance into electronic batch record initiatives

  Heather Schwalje

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• Performing microbial risk analysis on a standard compounding pharmacy aseptic fill process

  Anthony Grilli

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• The effect of L-arginine on mice placenta

  Mohanad A. Al-Bayati and Marawan A. Ahamad

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• Cleaning challenges in the dietary supplement industry

  Elizabeth Rivera

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• Myrica rubra fruit drink sub-chronic toxicity and hepatoprotective effect in rats

  Mohamed Fahad AlAjmi, Badraddin Mohammed Al-Hadiya and Kamal Eldin Hussein El Tahir

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• The informed consent form process: A basic contemporary standpoint for medical research professionals

  Peter Odeh

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• Immunosuppressive effects of mesenchymal stem cells versus corticosteroid in experimental model of arthritis

  Marwa Elhussiny Younis, El-denshary E. S. M. and L. A. Rashed

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• Comparative pharmacokinetics and compliance issues to optimize art- The Indian scenario

  Princy Louis Palatty, Sana Aboobaker, Manasa S. and Scandashree

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• A new cGMP bioassay involving electrophysiological recordings of CFTR currents

  Antonio E. Lacerda

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