Specialty Sections

The Animal & Veterinary Products Specialty Section (AVPSS) serves its membership and the general constituency of the Society of Quality Assurance in a variety of ways:

• Providing a forum to encourage interaction between professionals in the Animal Health and Veterinary industries; 
• Promoting SQA as the premier professional society for Animal Health Quality Assurance professionals; 
• Providing SQA members with updates on proposed and/or new regulations, emerging issues and regulatory trends; 
• Developing informative sessions and programs for the SQA Annual Meeting; 
• Providing SQA members and other interested professionals with information and training; and
• Establishing liaisons and fostering interactions with other professional organizations and regulatory agencies to maximize information exchange.

AVPSS has a subcommittee to address the topic of Electronic Data Capture.

 

The Beyond Compliance Specialty Section (BCSS) serves the Society of Quality Assurance (SQA) by inspiring exploration of issues that extend beyond compliance with regulatory requirements.  The BCSS approaches a broad spectrum of subject matter that supports or enhances, often surpasses compliance. The BCSS promotes and develops training programs or informational material that provide skills, knowledge, tools and resources to SQA membership in an effort to share best practices within the field of quality.  These are presented or made available at the SQA Annual Meeting or through other venues and media such as the SQA newsletter.  Current programs within the BCSS involve a number of subcommittees working on trainings, presentations, and publications involving quality tools that can be used to provide our membership skills they can use to manage their compliance needs.  The BCSS has provided several Quality College training courses in the last three years, providing quality tools useful in the GxP programs.

 

The Bioanalytical Specialty Section (BASS) serves as a network resource for QA professionals addressing regulatory compliance questions as applied to GxP bioanalytical testing.  Monthly teleconferences, webinars or face-to-face meetings (in conjunction with the SQA Annual Meeting) are held to discuss current issues in bioanalytical laboratories including current agency findings.  Section members discuss regulatory solutions to specific problems. All discussions are documented in detailed minutes that are posted via the BASS listserv on the SQA website.

BASS members also provide training on topics related to bioanalytical analyses, participate as requested by the SQA Board on committees to provide input on issues of regulatory significance, and work with other specialty sections on topics of mutual interest.

 

Biotechnology Subcommittee

The Biotechnology Specialty Section (BTSS) was formed to serve as a resource for SQA members in the interpretation of regulations (e.g., GLP, cGMP, GCP) and their application to nonclinical and clinical studies of products created through biotechnology (e.g., therapeutic proteins, transgenic crops). In 2014, the BTSS became a subcommittee of the Bioanalytical Specialty Section.

 

The Cell and Gene Therapy Specialty Section (CGTSS) was formed to address QA and regulatory challenges relative to preclinical development (GLP), clinical trials (GCP) and manufacturing (GMP) as well as Good Tissue Practices (GTP). Its purpose is to promote the training, education and sharing of information with quality professionals related to the CGT arena.

CGTSS meets six times per year.

Short Term Goals

• Provide a forum for interaction and discussion of topics specific to the manufacturing and testing (preclinical and clinical) of CGTs.
• Provide members with updates on proposed and new regulations, guidance, emerging issues and regulatory trends related to CGT.
• Support additional CGT posters and sessions for the 2024 annual meeting

Long Term Goals

• Develop webinars, training programs, and other informative sessions (which may include annual meeting presentations and Quality College classes)
• Collaborate with other specialty sections, professional organizations and regulatory agencies on topics of mutual interest in order to exchange information and help form the regulatory landscape with respect to quality.

 

SQA members with an interest in clinical research are invited to join the Clinical Specialty Section (CSS).  The CSS is the topical interest group within SQA that facilitates and promotes the development and implementation of Good Clinical Practices (GCP), and fosters the sharing of ideas, experience and expertise between clinical quality assurance (CQA) professionals. 

CSS members participate in:

• reviewing and commenting on draft guidances or regulations; 
• sharing the latest guidances and regulatory information; 
• discussing quality assurance and compliance best practices; 
• providing/receiving training via webinars or in person; and 
• working with other Specialty Sections to support responses to regulatory agencies and to provide GCP training support. 

CSS needs the active support and involvement of the best in the industry so that we are able to make significant contributions to the quality of clinical research. 

 

Welcome to the CVIC webpage on computer system validation & IT compliance. Computerized system validation and IT compliance is an ever evolving activity and the CVIC’s primary purpose is to disseminate current and applicable information to Society members.

CVIC membership is open to any SQA member in good standing. We encourage active participation for CVIC members and request that each member join one or more of the specialty subcommittees listed below. For more information please contact the CVIC-SS Chair or a current member.

CVIC Mission
It is the mission of the CVIC to provide the Society with best practices to maintain compliance of computer systems and related technologies in accordance with applicable laws, regulations, directives, and guidelines.

History of CVIC
The SQA Computer Validation Initiative Committee (CVIC) was initiated in July of 1996 as an ad hoc committee to provide current industry perspectives on computer validation issues for the QA professional. Today, it has grown in interest, size and standing.

In January of 2018 the CVIC was "rebranded" as the Computer Validation & IT Compliance Specialty Section to include a broader scope, including but not limited to: information/cyber security, vendor management, data protection, data integrity, development of data standards (such as SEND), governance risk & compliance, lectronic records, business continuity, records management, data centers, infrastructure, mobile apps, and artificial intelligence. Our underlying focus regarding computer system development, testing, implementation, maintenance, and decommissioning has not changed, but rather is incorporated into this broader scope.

The "new" CVIC consists of several subcommittees, including:

• Training
• Data Integrity & Governance (DIG)
• Audits & Vendor Assessments (AVA)

CVIC welcomes all Society members, irrespective of their experience and would be pleased if they can participate in any way they can.

The CVIC has been a very active Specialty Section, and member participation has been a hallmark of our success. Many CVIC members volunteer significant time and talent on the development of training modules for the CVIC computer validation training sessions, annual meetings, developing articles to be published in SQA newsletters, preparing/presenting webinars to members, or interfacing with regulators or other organizations on computer validation and Part 11 issues. The Committee also disseminates information to the members via newsletters, the SQA website, and roundtable discussions. 

 

SQA members that are in the early stages of their QA career, transitioned into a new Quality space, or have completely begun a new in a Quality career trajectory are invited to join the Early Career Professional Development Specialty Section (ECSS).

Vision
The Early Career Professional Development Specialty Section will focus on the growth of quality assurance professionals new to regulatory compliance by listening to members’ needs and promoting career opportunities.

Mission Statement

• Drive resources to develop professional growth
• Develop a forum for members to discuss challenges and exchange ideas
• Communicate with SQA leadership about the needs of quality assurance professionals new to regulatory compliance
• Establish liaisons with other Specialty Sections to increase awareness about relevant SQA offerings
• Provide and indicate volunteering opportunities to interested members
• Encourage leadership by example

 

SQA Good Laboratory Practice Specialty Section (GLPSS) includes members of three GLP Focus Areas: EPA, FDA and OECD. The GLPSS is a forum for exchanging ideas and experiences. Specialty Section members are charged with monitoring changes, trends and initiatives within the EPA, FDA and global GLP environment in regards to regulations and guidelines that pertain to the GLPs. This function includes interpretations on proposed or new regulations and emerging issues, assessing the impact of any changes, developing informed responses and circulating the information to the SQA membership. The GLPSS also dialogs with the FDA and EPA regulatory agencies or International representatives on behalf of SQA.

The Good Laboratory Practice Specialty Section (GLPSS) serves the membership by:

• Providing a forum for the exchange of ideas and experiences;
• Monitoring changes and trends in the US EPA, state agencies, and international pesticide and chemical regulatory issues pertinent to the GLPs;
• Monitoring changes to regulations and guidelines that pertain to the US FDA GLPs;
• Maintaining an awareness of global regulations and guidelines that are pertinent to the GLPs;
• Identifying GLP issues, developing informed responses, and disseminating the information to SQA members by posting information on the SQA website or publishing results;
• Interacting and commenting on regulatory guidances, standards and rules to reflect GLP practices; and
• Communicating with SQA Membership concerning GLPSS activities through the website, question-and-answer sessions and partnering with other SQA Committees and Specialty Sections.

 

Formerly a subcommittee of the GLPSS, this group has become a separate Specialty Section to better address specific topics related to the industry group regulated by the U.S. Environmental Protection Agency (EPA). The primary goal is to provide an avenue that enables SQA members who have a professional interest in this area to explore EPA GLP matters and related international regulatory compliance issues.

The EPA Specialty Section (EPASS) members are continually identifying new initiatives and developing existing initiatives that align with the SQA Strategic Plan such as the following:

• Hosting webinars on hot topics
• Presenting at the SQA Annual Meeting
• Developing web-based training
• Liaising and developing synergies with other organizations interested in EPA GLPs
• Monitoring trends in the EPA regulated industries
• Commenting on regulatory guidance, standards, and rules related to EPA.
• Network and benchmark with other QA professionals with an interest in EPA topics.

 

The Good Manufacturing Practices Specialty Section (GMPSS) fundamental goals are to find unique ways to revitalize and energize the SQA GMPSS in order to be a “go to” organization for GMP professionals; to provide opportunities and benefits for existing members; and to attract new membership in order to expand sharing of ideas, experiences, and expertise.

The GMPSS provides members with opportunities to:

• Network, benchmark, and interact with other QA professionals with an interest in “current” technologies and systems in order to comply with the GMP regulations globally; 
• Attend monthly teleconferences to exchange information on the interpretation and implementation of the latest regulatory guidance; review and comment on proposed regulatory documents; 
• Monitor changes and maintain awareness of GMP regulations and guidelines globally; 
• Recognize the common goal of meeting consumer expectations that each batch of medicine/drug will meet quality standards and will be safe and effective; and 
• Design webinars, provide training at SQA Annual Meetings and Quality Colleges, mentor QA professionals new to the GMPs, and develop on-line training courses for the SQA Education Committee. 

The GMPSS is one of SQA’s more unique Specialty Sections because of the diverse responsibilities (regulatory, Quality Assurance, Quality Control, Risk Management, etc.) and diverse types of products regulated by GMPSS members (prescription drugs, APIs, human drugs, veterinary drugs, blood products, vaccines, and drug products other than classic medicines such as fluoride toothpaste, dandruff shampoos, and sunscreens).

 

HPSS serves as a resource for SQA professionals interested in the field of histopathology (including necropsy, histology, and pathology) and provides updates on proposed and new regulations, guidance, emerging issues and regulatory trends related to histology and pathology.

HPSS Mission

Provide a forum for interaction and discussion of necropsy, histology and pathology (including pathology peer review) topics

Provide members with updates on proposed and new regulations, guidance, emerging issues and regulatory trends related to histology and pathology

Develop webinars, training programs, and other informative sessions (which may include annual meeting presentations and Quality College classes)

Provide members with information and training

Collaborate with other specialty sections on topics of mutual interest

Promote member collaboration and problem solving through SQA Connect

Liaise with other professional organizations and regulatory agencies to maximize information exchange and to engage industry experts

Sponsor the liaison role between SQA and the Society of Toxicologic Pathologists (STP)

Provide volunteer opportunities to interested members

 

The Medical Device Specialty Section (MDSS) serves as a resource to non-clinical and clinical quality assurance professionals in the interpretation and application of federal regulations to the medical device and combination drug/device industry. The MDSS endeavors to establish cooperative relationships with regulatory bodies, provide education and training with a medical device focus, and facilitate opportunities for industry professionals to exchange ideas on the unique challenges encountered by QA professionals in the industry.

MDSS activities include:

• Monthly teleconference calls; 
• Roundtable discussions;
• Online discussion forum; and 
• Education opportunities during SQA Quality College and Annual Meeting.

The MDSS members represent the industry’s leading medical device companies, contract research organizations, universities, analytical, histology and pathology laboratories, and quality assurance/regulatory compliance consultants. MDSS invites new members to join this growing Specialty Section.

 

PVSS Mission
The mission of the PVSS is to provide skills, knowledge and tools that will meet the needs of the membership, their peers, colleagues and customers through a broadened perspective for initiating, enhancing and maintaining processes that support compliance.

PVSS strives to be an industry group that shares information, learnings, inspection experiences, global regulatory PV landscape and requirements, industry trends, key performance indicators, PV audit techniques, and vendor management.

 

QACS Mission
The mission of the Quality Assurance Consulting Support Specialty Section (QACS) is to provide timely information and ideas to the membership through meetings and interactive media to assist the independent consultant with day-to-day activities, special projects, business ideas and networking opportunities.

1. Assist independent consultants or who may be considering a career as an independent consultant.
2. Identifying and responding to issues related to the business of independent consulting. Such issues may include, but are not limited to, for example organization type (e.g., LLC, Inc., S-Corp), accounting/taxes, banking, electronics, marketing, proposals, contracts, scheduling, subcontracting, expenses, and on-the-job nuances.
3. Sharing thoughts, experiences, recommendations, tools, templates, and other useful business resources to assist an independent consultant including, but not limited to, website links, personal contacts, books, articles, custom forms, and information.
4. Being a resource to a QACS member who may need business guidance or support.
5. Presenting on topics of interest about the business of independent consulting.
6. Providing a mechanism for members to identify resources for referrals.

QACS Vision
The vision of the Quality Assurance Consulting Support Specialty Section (QACS) is to focus on the development, promotion, and dissemination of information, ideas, and standards surrounding the business requirements and demands of being or becoming an independent consultant. 

 

The Scientific Archiving Specialty Section (SASS) serves as a resource for SQA professionals interested in the requirements of Scientific Archiving.

SASS Mission

• Provide a forum where SQA members can interact and discuss archive related topics.
• Provide members with updates on proposed and/or new regulations, emerging issues and regulatory trends related to archiving. 
• Develop informative sessions and training programs for the SQA Annual Meeting.
• Provide members with information and training.
• Collaborate with other specialty sections on topics of mutual interest. 
• Encourage awareness and importance of archival activities.
• Respond to questions submitted by members and publish the information on the Specialty Section web page.

Topics of interest discussed during the meetings include archive facility requirements, indexing and tracking systems, electronic data archiving and ensuring efficiency and accuracy of archive procedures, records and archived material. SASS invites members to join the Specialty Section to provide future meeting topics, assist in the development and facilitation of presentations and training, participate in scientific archiving initiatives and become leaders in our industry’s scientific archiving community.

 

The University Specialty Section (USS) serves its membership and the general constituency of the Society of Quality Assurance by:

• Providing a forum for interaction between industry professionals and University settings; 
• Promoting training for University students regarding Quality Assurance, GxP regulated research, and good documentation practices; 
• Promoting quality in research and regulated studies in the academic environment; 
• Promoting SQA as the premier professional society for University QA and GxP professionals; 
• Developing relevant, informative programs for SQA annual meetings; 
• Providing SQA members and other professionals with training specific to University studies; and 
• Establishing liaisons and fostering interactions with other professional organizations and regulatory agencies to maximize information exchange.

We welcome all individuals interested in regulated research at the University to join the USS and participate in monthly teleconferences, provide ideas for topical discussions, assist with presentations and network with other USS members.