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

Accepted Abstracts

• Chinese regulatory requirements

  Wenkai Ma

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• Safety and potency test for PV and ERA based cell culture anti-rabies vaccine produced in Ethiopia

  Abebe Mengesha

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• Lean Six Sigma in pharmaceuticals: Facts & dreams

  Ahmed Medhat Abu Ghida

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• Method, development and validation for simultaneous estimation of promethazine hydrochloride and pholcodine in bulk and marketed formulation (Linctus) by UV spectrophotometery

  Ajay Sharma, Navneet Upadhyay, Sameer Sapra, K. L. Dhar and Megha Sharma

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• Parameter validation of analytical methods of insecticide residue analyses in foods of animal origin, feed and water

  Amsalu Debebe and S. Kuttalam

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• Inspection and audit readiness for medical devices

  J. Andrew Harrison

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• Surface challenge testing to qualify disinfectants including sporicides for control of bioburden on production facility surfaces

  Anne Cornish Frazer

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• Improving clinical research data in Africa: The understanding and implementation of laboratory quality management systems (LQMS)

  Augustine A. Onyeaghala

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• HACCP (Hazard Analysis and Critical Point)

  Barbara Moreira

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• Cleaning, disinfection and hygiene

  Barbara Moreira

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• A lean six sigma approach to the improvement of the selenium analysis method

  Bronwyn Claudia Swartz

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• Forced degradation studies and analytical method validation

  Bujji Reddy Kanchi

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• CAPA and risk management

  Rucha Majmundar Mehta

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• Quality by design: Generic versus brand drug development, delays in review of drug applications at FDA, regulatory problems and solutions

  Charan R. Behl

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• Effective supplier management for the medical device industry ©2013

  Christopher Joseph Devine

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• GMP in formulation development

  Chryssoula Stamatogianni

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• Regulatory inspection findings at the GMP/GCP interface

  Dave Sharma

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• Bioanalytical method validation using LC-MS/MS

  Bijay Aryal

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• The application of quality by design principles to analytical methods

  Peter Jones

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• Bioburden acceptance criteria in cleaning procedures for processing equipment

  Elizabeth Rivera

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• Designing an effective cleaning procedure for medical devices using laboratory studies

  Elizabeth Rivera

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• The influence of qualification and validation studies on quality risk assessment

  Eng. Nabil Hoseh

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• Medical device quality audits

  George G. Calafactor

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• QA inspection

  Hassan Mostafa Mohamed

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• Ending the clinical IT lifecycle with decommissioning of GCP clinical data

  Jesper Ilm

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• Steam sterilizer validation from FAT to PQ

  Jonathan A. Wilder

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• Guidelines on packaging for solid dosage pharmaceutical products

  Jorge Martinez

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• Choosing a CMO and manufacturing of NCE API in India

  Kamalesh Rao

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• GMP (Good Manufacturing Process): A mandatory aspect in pharmaceuticals manufacturing

  Kapil Verma

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• Being prepared for QA/compliance audits

  Kristin Kelley

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• GCP and implementation in an academic environment

  Leonie J. Crampton

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• Bridging the gaps of China GCP regulation compared to ICHGCP to effectively conduct multinational clinical trials (MCTs)

  Libin Zhao, Henry Sun and Zhixin Guo

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• GMP in pharmaceutical industries: The failures and their investigation

  Lokesh Kumar Gupta

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• Food packaging regulation in EU and its developments

  Luigi Rossi, Keller and Heckman

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• Time of change not only by election but also by regulation

  Mazhar Shams

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• Regulated analysis/bioanalysis (GxP) for clinical research and commercialization from global perspectives

  Michael Zhou

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• External QA audits: Ensuring compliance at the contract manufacturing sites

  Mohammed R. Khan

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• Radiosynthesis and biodistribution of an 125I-labeled resveratrol derivative: A potential radiolabeled imaging agent

  Mohammed I. El-Gamal

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• Risk-based validation of single-sign-on access control to GxP regulated systems

  Henk-Willem Mutsaers

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• DHF, DMR and DHR-The three Ds of medical devices

  Rama K. Pidaparti

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• Risk-based approach in prioritization of site and inspection for GMP

  Rama Roohi B. Obaid and Obaid Ali

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• 5 things a realistic and functional quality system should have

  Rosario Quintero-Vives

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• cGMP at GEA westfalia separator

  Sean Eicher

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• Quality requirements for pharmaceutical product

  Soumah A. Qutob

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• The necessity of establishing a harmonized international regulatory system for the control of APIs

  SUN Yueping

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• Effective integration of quality risk management into the CAPA system

  Sundar Ganesan

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