SQA hosts educational symposia periodically. Please check this page for upcoming symposia, as well as materials available for purchase from past symposia.
SQA Special Symposia
San Jose, CA, USA
11 - 15 October 2010
These symposia are being offered in conjuction with SQA Quality College training courses. Visit the Quality College page for further details as they become available.
Achieving Consistency in GLP Inspections and Common Regulatory Interpretations
Multinational companies have to operate nonclinical laboratories under different national GLP regulations and compliance monitoring authorities. Although minor differences in national GLP regulations exist, the primary challenge for corporations is dealing with disparate interpretations of those regulations. This symposium will bring together representatives from national monitoring authorities and the regulated industry to identify significant areas of monitoring authority disparity, the consequences to multinational corporations, and propose solutions to achieve greater consistency.
Confirmed Speakers:
GLP Requirements: How Different Are They?, Hermann Lehn PhD, F. Hoffmann-La Roche Ltd, Switzerland
Differences in Enforcement of GLP Requirements, James McCormack PhD, Charles River Laboratories, USA
Inspector's Interpretations of GLP Requirements: An Industry Perspective, Jane Goeke PhD, RQAP-GLP, GlaxoSmithKline, USA
Accreditation and Compliance Monitoring Inspections, Colin Brown, Charles River Laboratories, UK
Value of the OECD Mutual Joint Visit Program, Don MacGregor, Ret., Environment Canada (Invited), Canada
Changes in the GLP Regulations and Monitoring Authorities: The Effect on Enforcement of GLPs, Francisca Liem, US EPA, USA
EU Efforts to Achieve Greater Consistency among European Monitoring Authorities, Dr. Sergio Caroli, Department of Food and Animal Safety, Italy
FDA Perspective on Review and/or Acceptance of International Nonclinical Data/Studies: Inspections and Collaborations among Monitoring Authorities, C.T. Viswanathan PhD, US FDA, USA
Future Challenges for QA, Rik Hendriks, Janssen Pharmaceuticals, Belgium
Panel Discussions on the following topics:
Solutions: Achieving Better Alignment of Regulations
Solutions: Achieving Monitoring Authority Adherence to Regulations
Technical or Emerging Issues that Influence Compliance: Path Peer Review, Clinical Sample Analysis, Digital Imaging, Access to QA Findings
Moving Forward with Solutions
The Changing Face of Global Clinical Trials from a Good Clinical Practice Perspective
The GCP symposium will focus on five points reflective of changes in the conduct of global clinical trials.
Regulatory: FDA and other regulatory authority speakers will discuss recent inspections, efforts to harmonize and share information between regulatory authorities, and other hot topics. An open panel Q&A discussion will follow.
IRB: Speakers will discuss IRB changes amidst recent IRB missteps and what went wrong in the first place, auditing IRBs from a CRO and sponsor perspective, and what IRBs look for when they review clinical trials. A panel of independent IRB and CRO speakers will be available for Q&A following the afternoon presentations.
Electronic medical records: The FDA announced in July its intent to begin Part 11 focused inspections. How can industry prepare itself and clinical trial sites for inspections focusing on electronic medical records, computer systems, auditor/monitor/inspector access to systems and electronic signatures? An open panel discussion will follow morning presentations.
Investigator oversight: Speakers will focus on auditing for investigator oversight globally and domestically.
GCLPs: Greater emphasis is being placed on how clinical laboratories handle and analyze human specimens for clinical trials. GCLP best practice guidelines will be discussed.
Confirmed Speakers:
EU Regulatory Inspection Experiences, Barney Horne, PPD Inc, UK
Topic TBD, Jane Kreis, US FDA, USA
Investigator Oversight, Chris Both RQAP-GCP, Falcon Consulting Group LLC, USA and Cathy Stevens-Hernandez RQAP-GCP, Genentech Inc, USA
IRB Site Review, Tanna MacReynold CIP, Western Institutional Review Board (WIRB), USA
Auditing IRBs, Liz Keller RN, MAOM, Charles River Laboratories, USA
Measuring and Evaluating IRB Quality and Accreditation of Human Research Protection Programs, Marjorie Speers PhD, AAHRPP, USA
- Electronic Medical Records, Chris Wubbolt, QACV Consulting, USA
Expectations from Sponsor, Site and Current Issues Such as Access to EMRs at the Site, Reem Sharif MD, Omnicare, USA
- IRB Issues, Erica Heath, IRC IRB, USA
- GCLP, Tobin Guarnacci CQA, CBA, M(ASCP), BioMarin Pharmaceutical Inc, USA
Supporters
Worldwide Supporter:
International Supporter:
Co-sponsors
The following organizations are co-sponsoring these symposia along with the Society of Quality Assurance (SQA). Members of these organizations who are not also members of SQA are eligible to register for a symposium at a reduced registration rate. To take advantage of this rate, co-sponsor members must register using the PDF registration form. If you register online, you will be charged at the highest registration rate instead of the co-sponsor member rate.
Past Symposia