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Qualification of Impurities, Leachables, Extractables: Residual Solvents and Excipients

 
  April 12, 2016  
     
 
CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
3-4 October 2016


Who Should Attend?
This course is intended for professionals in the Pharmaceutical, Medical Device, Biotech and related industries. It will be especially beneficial to the following:

  • Toxicologists, Pharmacologists, Pathologists, Biologists working in Academics, Government and Industry
  • Study Directors conducting Pre-clinical studies
  • Those who wish to become Study Directors in Pre-clinical studies
  • All the scientific/study personnel working in Pre-clinical GLP studies
  • Those who wish to take the DABT exam and all of those who will be giving recertification exam for the DABT
  • Regulatory staff (DCGI, CIB, OECD etc) handling Preclinical studies
  • Government GLP study monitoring staff
  • All veterinary staff involved in animal welfare, handling and maintenance of vivarium in GLP toxicology facilities
  • Academic community who teach Toxicology
  • Government Scientific Institutes and private laboratories who support Pre-clinical GLP studies

 

Course Description
This intensive and accredited 2-day training offers a workshop on the assessment and qualification of impurities, degradants, leachables and extractables, including a short course on Quantitative Structure Activity Relationships (Q)SAR basics and methods and their uses in drug and device development and safety. The accredited training will include discussion on the general considerations for drug packaging and medical device leachables and extractables. In addition, a thorough review of pharmaceutical guidelines for impurities, degradants, residual solvents, elements along with the qualifying of excipients will be covered. Approaches and case examples developed over more than ten years of successfully meeting global regulatory requirements and needs will be included.
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
Shayne C. Gad, PhD, DABT; Principal, Gad Consulting Services (GCS)

Dr. Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1971) and after active duty service in the U.S. Navy, Ph.D. in Pharmacology/Toxicology (Texas, 1977) DABT, Principal of Gad Consulting Services, a twenty-three year old consulting firm with eight employees and more than 500 clients in the pharmaceutical and medical device industries, including providing QSAR and impurity, leachables and extractables assessments and qualifications. Past President of the American College of Toxicology, the Roundtable of Toxicology Consultants and three of SOT’s specialty sections, and recipient of the American College of Toxicology Lifetime Contribution Award in 2008. Served on Council, Membership, Program, and Animals in Research committees for ACT, multiple committees in SOT, and currently on the regulatory opinions committee of the Society of Toxicologic Pathologists. Previously at CMIR Chemical Hygiene Fellowship, Allied Chemical, Searle, Becton Dickinson and Synergen. He has authored or edited 47 published books and more than 350 chapters, articles and abstracts in the fields of toxicology, statistics, pharmacology, drug and device development and safety assessment. He has more than 39 years of broad based experience in toxicology, drug and device development, statistics and risk assessment, and has specific expertise in neurotoxicology, in vitro methods, cardiovascular toxicology, inhalation toxicology, immunotoxicology, risk assessment and genotoxicology. Grant reviewer for EPA, CAAT, NIH, and Canadian Health. He has direct involvement in the preparation of INDs (109 successfully to date), NDA, PLA, ANDA, 510(k), IDE, CTD, clinical data bases for phase 1 and 2 studies, and PMAs. Served as the COO of two pharmaceutical companies while a consultant. He initiated and has conducted the triennial toxicology salary survey as a service to the profession of toxicology for the last 39+ years.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: jmorbit@cfpa.com
 
   
 
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