GxP Lifeline Feature Article

All Shook Up Without QA:
A Brief Look at the 24th Annual SQA Meeting
By Catherine M. Bens

Another well-attended and enlightening annual meeting of the Society of Quality Assurance (SQA) was held on April 20-25, 2008 in Memphis, Tennessee. In keeping up with the theme of "All Shook Up Without QA," the meeting offered the state-of-the-art experience in promoting and advancing the principles and knowledge of quality assurance essential to regulated research in the human, animal and environmental health sciences. For those that have never attended an SQA annual meeting, this year's meeting, like those of the past, offered professionals working in the pharmaceutical, agricultural, and chemical industries a unique opportunity to network with sponsors, peers, regulators, consultants and vendors and to attend a wide array of educational presentations, posters, and special events all carefully designed to highlight current issues critical to the conduct of regulated research in a fast-paced, fun atmosphere. This year's meeting, perhaps more than in other recent meetings, had a sharpened focus on upcoming changes in federal policy and emerging international issues and the critical role quality assurance plays in successful study conduct in a complex regulatory and research environment.

A number of key themes emerged including potential new advancements in regulatory guidance and policy as exemplified by presentations on the United States Food and Drug Administration's proposal to modernize the Good Laboratory Practices and the upcoming Red Apple II document release.

Let me give you a brief tour of the meeting. Following a history of focusing on professional advancement, activities began well before the annual meeting, when the SQA Registration of Quality Assurance Professionals Program offered both the GLP and GCP examinations for those interested in gaining professional acknowledgement through registration. The exam was followed by two days of pre-conference training by invited subject experts offered through the SQA Education Committee. Courses ranged from basic to advanced training in Good Laboratory, Clinical and Manufacturing and Device Practices and included such specialty areas as bioanalytical, biotechnical, computer validation and good practices in veterinary research. For the second year, post-conference training was also offered, including a half-day course on Leadership Training, which was complementary to SQA members.

The technical conference was packed with opportunities for discourse. Three days of multiple-track concurrent and plenary sessions offered something for everyone at almost all times, and it was often difficult to choose which track to attend. Presentations were selected from abstracts solicited via a well-promoted online abstract submission process to ensure a program of interest to everyone, including QA professionals, management representatives, study personnel and regulatory authorities from around the world. In addition to a full poster session, platform presentations covered such topics as bioanalytical and animal health subjects, computer systems (including information regarding their validation and use), electronic data integrity, the roles of QA and risk management in clinical, laboratory and manufacturing environments, auditing skills, ethical considerations, university issues, as well as many other special topic updates.

Plenary sessions cut right to the point with presentations by keynote speakers and regulatory authorities. A number of key themes emerged, including potential new advancements in regulatory guidance and policy as exemplified by presentations on the United States Food and Drug Administration's proposal to modernize the Good Laboratory Practices and the upcoming Red Apple II document release. It became clear during presentations on OECD international harmonization activities and an overview of the international GCP harmonization and GLP case study projects sponsored by the Japanese Society of Quality Assurance that international differences in regulatory interpretation, implementation and subsequent efforts at harmonization are also extremely active centers of thought.

Because the quality assurance profession typically involves interactions with all levels of management, scientific and support staff, the peripheral events were almost as valuable as the main presentations. A well-attended exhibition provided opportunities to share information on technological advances and services. In return, the conference offered exhibitors an opportunity to market products and services designed to assist attendees in competing worldwide in a regulated environment. Sponsor and consultant information was readily available.

For those new to the QA field or looking for a new career challenge, job postings and a free career services area were also provided. The career services area allowed professional and discrete one-to-one dedicated time to conduct mock interviews, review resumes, and strategize market opportunities with job seekers and hiring managers. The annual meeting also provided specialty sections, committees and local SQA chapters an opportunity to meet face-to-face in peripheral meetings throughout the week. Finally, for those who wanted a little quiet time away from the conference bustle, a reading room was available, providing key literature in the quality assurance field.

Although the week was jammed with events, the SQA annual meeting also offered plenty of opportunities for the other type of jamming. Memphis is famous for southern jazz and the opening reception was certainly soulful! Good food, a live jazz band and friendly faces (some old friends and some new), made for a lovely kick-off event. The International Relations Committee continued the musical ambiance during their reception, where members were entertained with a jam session by the SQA members' band "Deviations" featuring music from around the world. And for those who really wanted the Memphis experience, attendees had an opportunity to visit the home of the "king" with a special bus trip to Graceland, the home of Elvis Presley. The hotel location and the main street trolley made for easy access to the downtown nightlife throughout the week.

Next year marks the 25th anniversary of SQA annual meetings. We'll be celebrating a quarter-century of providing the most current thinking in conducting regulated research and establishing effective and efficient quality systems in an increasingly complex and technological world. I hope to see you there.

For more information on the Society of Quality Assurance, local chapters and the many upcoming events please visit the SQA website at http://sqa.org.

Catherine Bens serves as a Director for the Society of Quality Assurance and chairs the SQA Board of Publications Committee. She is also the quality assurance manager for the USDA National Wildlife Research Center in Ft. Collins, Colorado.

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