Society of Quality Assurance

Transcription

1 Membership Brochure 2018 Society of Quality Assurance Promoting Quality in the Regulated Research Community

2 Membership Types ACTIVE MEMBERSHIP Active members shall receive all tangible benefits of membership and may participate in nonelected Committees and Specialty Sections. Active members are eligible for election as Officers, Directors and Elected Committee members and are entitled to vote on all matters pertaining to the affairs of the Society. Active Membership Requirements: Applicants for Active membership must have at least two (2) consecutive years of experience in a research quality assurance role related to the audit functions to assure compliance with Good Laboratory Practices (GLP), Good Clinical Practices (GCP) or Good Manufacturing Practices (GMP) within five (5) years immediately preceding the date of application. Documentation Required: Completed membership application, payment of dues and all of the following: Résumé or Curriculum Vitae (CV) verifying current, active involvement in the QA audit profession by documenting two (2) consecutive years of professional experience in QA within five (5) years immediately preceding the date of application. Quality assurance experience should be related to audit functions to assure compliance with GCP, GLP or GMP as the Regulations/Standards/Principles relate to support of research activities. U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), Organisation for Economic Co-operation and Development (OECD) or other national/international equivalents are acceptable. These activities may be demonstrated through submission of documents supporting employment history, professional activities, affiliations, published articles, or attendance at training or educational sessions. These activities should be documented on the résumé or CV. Attendance at one QA meeting OR Written sponsorship from two SQA Active Members Attendance at one (1) QA Meeting/Training: Applicants shall provide evidence of attendance at a recent (i.e., within five years of the date of application) research quality assurance meeting or training. Acceptable meetings include those sponsored by SQA, SQA chapters or other allied research quality assurance organizations. A detailed syllabus must be attached for training sponsored by an organization other than SQA or any of its chapters. Written sponsorship from two (2) SQA Active Members: Applicants shall provide written sponsorship from two (2) SQA Active Members in good standing. Letters of sponsorship shall be dated within one year of the date of application. An example letter of sponsorship is available on the SQA website. Application Review: All Active applications are reviewed by the SQA Ethics and Membership Credentials Committee and the SQA Board of Directors and take 4-6 weeks, from date all documentation is received, to be processed. AFFILIATE MEMBERSHIP Affiliate members shall receive all tangible benefits of membership and may participate in nonelected Committees and Specialty Sections. Affiliate members shall not vote and shall not be candidates for any election. Affiliate Membership Requirements: Applicant must have an interest or current involvement in the quality assurance profession. Documentation Required: Completed membership application and payment of dues. Application Review: All Affiliate applications are reviewed by the SQA Board of Directors and take 2-3 weeks to be processed.

3 Membership Types STUDENT MEMBERSHIP Student members shall receive all tangible benefits of membership and may participate in nonelected Committees and Specialty Sections. Student members shall not vote and shall not be candidates for any election. Student Membership Requirements: Applicants for Student membership must be currently enrolled in an accredited college or university with a minimum of 12 credit hours actively pursuing their undergraduate, post-graduate or doctoral degree, or be enrolled in a school of professional studies related to research/regulatory quality assurance. Documentation Required: Completed membership application, payment of dues and one (1) of the following: Letter/signature of Department Chair/Advisor Completed Student Verification area located on the hardcopy application Official verification document such as (but not limited to) an official transcript or current class schedule issued by the academic establishment. Note: Documentation of enrollment and written verification of student status must be submitted with a completed application each year for renewal. Application Review: All Student applications are reviewed by the SQA Ethics and Membership Credentials Committee and the SQA Board of Directors and take 4-6 weeks to be processed. OUTREACH MEMBERSHIP Outreach members of the Society shall receive all tangible benefits of membership and may participate in nonelected Committees and Specialty Sections. Outreach members shall not vote and shall not be candidates for any election. Outreach Membership Requirements: Applicants for Outreach membership must reside in a low/middle income country as defined by the World Bank and shall demonstrate active professional involvement in research/regulatory quality assurance. These activities may be demonstrated through employment history, professional activities, affiliations, published articles, or attendance at training or educational sessions. These activities should be documented on the résumé or CV. Documentation Required: Completed membership application and copy of current résumé or CV documenting involvement in professional activities related to research/regulatory quality assurance. Note: To renew each year, Outreach members must confirm their membership by providing a copy of their current résumé or CV confirming their continued participation in professional activities related to research/regulatory quality assurance. Application Review: All Outreach applications are reviewed by the SQA Board of Directors and take 2-3 weeks to be processed. MEMBERSHIP RECLASSIFICATION All Affiliate members of the Society are eligible to reclassify to an Active membership at any time and at no cost. Upon approval the member will be reclassified as an Active member and would then be eligible for election as an Officer, Director or Elected Committee member and entitled to vote on all matters pertaining to the affairs of the Society. Reclassification Requirements: Applicants who wish to reclassify to an Active membership must have at least two (2) consecutive years experience in a research quality assurance role related to the audit functions to assure compliance with Good Laboratory Practices (GLP), Good Clinical Practices (GCP) or Good Manufacturing Practices (GMP) within five (5) years immediately preceding the date of application. Documentation Required: Completed Reclassification application and the supporting documentation required for an Active membership noted above. Application Review: All Reclassification applications are reviewed by the Ethics and Membership and Credentials Committee and by the SQA Board of Directors and will take 4-6 weeks, from receipt of all required documentation, to be processed.

4 Benefits of Membership SQA Annual Meeting and Formal Training Opportunities Annual Meeting - held for three days each year in different locations throughout North America: Registration fee discount for members Formal presentations with current developments and information Workshops and round table discussions Interactions and networking opportunities with international, national, state and regional regulators Training sessions Networking with peers and consultants Career Center onsite Poster session on current issues Member consultant information Exhibition featuring suppliers to the industry Formal Training Opportunities - basic, specialized and professional enhancement Registration fee discount for members Two full days preceding and one day following the Annual Meeting in the Spring Five day Quality College in September Online Learning Opportunities SQA Membership Directory - available on members-only website Members-Only Website Searchable listing of members includes name, affiliation, address, telephone and Searchable by name, company affiliation, geographical location and area of expertise Customizable My SQA profile with picture and biography for online networking SQA Newsletter - electronically distributed bimonthly Contact Us News and updates pertinent to regulatory and research quality assurance (GCP, GLP, GMP, etc.) In-depth discussion of current regulatory issues Regional Chapter, Committee and Specialty Section reports Relevant articles and book reviews SQA training and meetings calendar Advertisements for job openings, professional services and much more Technical article supplements Access to a searchable database with information on 483s Regulatory news providing information links to current regulatory issues and trends eforum and integrated listserv for all SQA Committees and Specialty Sections Regulatory Q&A database containing hundreds of regulatory questions that have been answered by key EPA and FDA representatives and SQA leaders Searchable bibliography of references with over 1,000 quality assurance references Free webinar recording library Current employment opportunities, Career Center and links to consultant advertising Specialty Section and Committee areas featuring pertinent industry information Links to regulatory agencies, national QA societies, SQA Regional Chapters, liaison organizations and corporate supporters SQA organizational charts and Standard Operating Procedures SQA calendar of meetings, training and events Society of Quality Assurance Headquarters 154 Hansen Road, Suite 201 Charlottesville, VA USA Tel: Fax: sqa@sqa.org

5 2018 SQA Membership Application Active Membership - $ Supporting documentation is required. See SQA Membership brochure for details. Affiliate Membership - $ No documentation required. Non-voting level of membership. Name: Mr. Ms. Dr. (Please circle) (First) (Middle Initial) (Last) (Suffix) Title/Position Held: Company: Street: City, State, Zip: Country: Telephone: Birthdate: address is required for SQA members-only website access. SQA has a Mentoring Program. Would you be interested in being a Mentor, Mentee or both? How did you hear about SQA? Were you referred by an SQA Member? SQA Member named here will be entered in a special prize drawing! Please complete the following: Areas of Regulatory Responsibility (Check all that apply) GCP GLP GMP Animal Welfare Other: Job Function (Check one) Analyst (Chemistry/Diagnostic/etc.) Animal Health/Welfare Archivist Auditor/Inspector Career Counseling/Recruiter Consultant Clinical Coordinator/Administrator IT/Software Engineer/Specialist Management QC Specialist Recruiter/Career Specialist Regulators/Government Regulatory/Legal Affairs Scientist Study Director/PI Study Monitor Trainer/Instructor/Educator Other: (Specify) Areas of Expertise (Check all that apply) 6 Sigma AAALAC/AALAS Certification Animal Health Archiving Biotechnology Continual Improvement Education/Training Environmental Chemicals Ethics in Science Food Human Biologics Human Drugs Information Technology ISO Medical Devices Metrology Pathology/Histology Project Management Quality Control Regulatory Affairs - US Regulatory Affairs - International Statistics Validation - Computerized Systems Validation - Analytical/Bioanalytical Methods Validation - Process Veterinary Biologics Veterinary Drugs Other:

6 Name: (First) (Middle Initial) (Last) (Suffix) SQA Privacy Policy SQA does not sell or share your information with outside parties. Contact information is used only to send SQA publications, information, and/or announcements. In addition, SQA maintains an Online Member Directory that is accesible through the Members-only website. You may update your communication preferences through the Members-only website at any time. Vist to view the full SQA Privacy Policy and Legal Disclosure in its entirity. Please do not communicate with me via . Please exclude me from the Online Member Directory. SQA Code of Ethics Adherence to ethical standards is a key criterion in earning and preserving the trust placed in the research quality assurance profession and is a requirement for membership in SQA and participation in its activities. I, as a member of the Society of Quality Assurance, shall: Maintain a high level of personal integrity and professional competence; Act always in a manner that reflects creditably upon my profession; Maintain an objective attitude towards evaluation of facilities, studies or product integrity regardless of any internal or external influences; Protect confidential information; Report findings accurately and honestly and make recommendations impartially; Avoid situations where my professional judgment may be compromised; Understand, promote and implement the laws, regulations, guidelines and standards applicable to the field of quality assurance and specifically to my position; and Uphold this Code of Ethics in the conduct of my duties and in my professional associations. I certify that to the best of my knowledge all provided information is true. I understand that the documentation I submit in support of Active Membership may be verified for accuracy by the EMCC and that inaccurate information may result in denial of Active Membership. I have read and accept the SQA Code of Ethics. Payment Details Applicant s Signature Total Due: $ USD (pay for one year, membership dues ending 31 December 2018) (choose one) $ USD (pay for two years, membership dues ending 31 December 2019) Payment Method VISA MasterCard American Express Check # Wire transfers will be subject to an additional processing fee. Please contact SQA Headquarters for more details. Remittance must be made in U.S. Dollars. A $25.00 surcharge may be assessed to cover any collection fees. Cardholder Printed Name Signature Cardholder Address Credit Card Number Code Exp. Date Please include bank card code (3 or 4 digit code) located on back of card. Date Please send completed application and payment to: Society of Quality Assurance, 154 Hansen Road, Suite 201, Charlottesville, VA USA Tel: Fax: If sending by facsimile, please remember to send both sides of the application.