SDRAN
San Diego Regulatory Affairs Network
Welcome to the SDRAN Website. Please explore our website to learn more about the organization including our monthly educational events, our professional development programs, jobs at local companies, and other membership benefits. You can also sign up for upcoming events, become a member, or sign up for our mailing list.
Note: Our new website is currently under construction, and we appreciate your patience. Feedback is welcome!
February 15th, 2012
The Regulatory & Ethical Issues Involved in Oocyte Donation for Research
Speaker: Jeff Janus
About SDRAN
Membership
Educational Programs
Events and Seminars
SDRAN is a nonprofit organization dedicated to educating and supporting our members through various educational and professional development .
Why become a member of SDRAN?
Member appreciation event (annual wine tasting social)
Reduced fees for meetings
Reimbursement for RAC exam preparation expenses
As a benefit of membership, SDRAN offers a variety of educational programs to assist with your continued professional development.
Learn about our upcoming events offering educational seminars and an opportunity to network with colleagues, peers and industry leaders.
Open Internships
Read More
SDRAN Latest News
Welcome 2012
Welcome to the 2012 SDRAN Board Members! See our new SDRAN Board Members and the Annual Report here.....
We'd like to welcome you to our newly redesigned website. We've been hard at work on the new site and hope that you find your experience with it both user friendly and enjoyable. Our goal with the redesign of our website was to make the information that we provide to you easier to find and more timely. If you have any questions or comments about the site in general, or anything in particular, please let us know.
SDRAN is now accepting Credit Card Payments and On-Line Event Signup. See our Events and Seminars Page!
SDRAN Website Sponsor
Quality Compliance Partners, Inc. is proud to be the corporate sponsor of SDRAN. We are a quality and regulatory compliance consulting firm headquartered in San Diego providing regulatory strategy and submissions support, quality assurance, validation, auditing, project management and GXP training services. Our commitment to our clients is to provide practical solutions in all areas of service.
Where Regulatory Affairs Professionals
Come Together
WINNER!
Wealth
Manager
of the Year
SDRAN is a nonprofit organization dedicated to educating and supporting our members through various educational and professional development venues including:
• Monthly educational programs
• RAC Study Groups to prepare for the US and EU exams are offered every summer
and include a reimbursement option for those who are not eligible for a company
reimbursement. The 2011 Study Group is closed for the year.
• Mentoring program to help promote the career growth and development of our
members.
2011 Annual Meeting.pdf
BYLAWS.pdf
SDRAN President letter.PDF
VP Programs:
Frank Pokrop
Director, Regulatory Affairs
CareFusion
VP Website Management:
Bonnie Ward
President & CEO
Quality Compliance Partners, Inc.
Treasurer:
Jerome Bressi, Ph.D, RAC
Secretary:
Christine Federovitch, PhD, RAC
Project Manager, Genoptix
President:
Lane Arbittier, RAC
Associate Director of Quality Assurance
Zimmer, Inc.
President - Elect:
Natalie Kennel
VP of Communications/Membership:
Sybille Sauter
VP Education:
Rachel Hernandez
MAILING ADDRESS
P.O. Box 927595
San Diego, CA 92192-7595
Become a Member of SDRAN:
The SDRAN membership fee for 2012 is $55.00 per person. Membership is effective from January 1, 2012 through December 31, 2012. As an incentive for early payment, If you pay your dues in November your membership will be good for 14 months - from November 2011 until December of 2012.
Education and Training
•Monthly educational programs in a variety of areas (devices, drugs, biologics, combination products)
•Periodic half and full day workshops
•Expert speakers from government and industry
•Earn continuing education units for recertification such as RAC, ASQ
Professional Development Opportunities
•RAC examination preparation study groups (US and EU) with experienced topic leaders
•Broaden your knowledge in all practice areas
•Learn new skills
•Website links to local regulatory educational programs, related organizations, regulatory authorities
•Participate in our Mentoring Program as a mentor or mentee
•SDRAN Internship Program
•Website job postings
•Participate as a volunteer with our organization
Networking
•Opportunities to expand business and professional contacts
•Interact with local colleagues involved in RA, QA, and Clinical
•Special Jobs Networking opportunities to improve job hunting skills
•Join our group in LinkedIn
Other Benefits
•Member appreciation event (annual wine tasting social)
•Reduced fees for meetings
•Reimbursement for RAC exam preparation expenses
Values of Being a SDRAN Member:
Learn from the real-world experiences of industry experts and practitioners who will show you how to achieve outstanding results.
Take advantage of the informal networking opportunities at all of our events, including: peer networking, idea exchange, speaker meet and greet and many other informal opportunities!
SDRAN programs are usually held on the third Thursday of each month unless otherwise noted. SDRAN does not usually schedule a program in December. The educational programs cover a variety of areas (devices, drugs, biologics, combination products), with expert speakers from government and industry.
2012 SDRAN Programs_12-1-11.pdf
Current Pharmaceutical and Biotech FDA Compliance Issues and Annual Membership Meeting
Tuesday, January 17, 2012
5:30 pm - 7:00 pm
-Jeff Yuen
Early Registration Ends: January 15, 2012
Online Registration Ends: January 16, 2012
Cash and Checks accepted for Walk-ins
FDA's enforcement activities have been on the increase this past year!
Please join Commander Jeff Yuen as he presents an update on current FDA cGMP regulatory inspection compliance trends. During his presentation he will share special insights gained from his greater than 25 years of FDA and industry consulting experience, as well as share recent Warning Letter trends. It is important to understand what impact these enforcement activities may have on your organizations operations. As a former FDA Los Angeles District drug investigator, former Regional Biotech Team member (precursor to Team Biologics), and International Inspection Team Cadre member, Jeff can provide an in-depth perspective on ways companies can ensure they maintain a compliant environment.
JAN 2012 Flyer.pdf
Regulatory Intelligence
Speaker: Sybille Sauter
2011 Events Summary.pdf
January 2011.pdf
February 2011.pdf
March 2011.pdf
April 2011.pdf
May 2011.pdf
June 2011.pdf
July 2011.pdf
August 2011.pdf
September 2011.pdf
October 2011.pdf
November 2011.pdf
AMERICAN MEDICAL WRITERS ASSOCIATION AMWA Pacific-Southwest Chapter
Good/Bad Authoring Practices and the Impact on eCTD Quality and Compliance
January 28, 2012
AMWA Pac-SW January 28 2012 Program Announcement.pdf
Creating electronic submission-ready documents is essential for both FDA and global filings. Learn key tips to help you and your authors excel at making it happen!
Antoinette Azevedo, President & CEO
e-SubmissionsSolutions.com
Ms. Azevedo advises all sizes of biotechnology and pharmaceutical companies on the use of technology to manage regulatory documents and publish electronic submissions.
ONLY $20.00
Agenda:
11:30 to 12:00 Networking
12:00 to 1:00 Lunch/networking
1:00 to 2:30 Presentation
SDRAN Internship Program
In 2011 SDRAN established a pilot internship program with the San Diego Life Sciences Community to provide additional educational opportunities for our members. The work experience is actual work in the regulatory, clinical, QC/QA or Project Management field, for a 3-6 month time period that will be meaningful to the individual and contribute to the goals of the company. Learn more about our program and our current internship(s) below.
Internship Program.pdf
Access Scientific Internship.pdf
RAC Study Group
REGULATORY AFFAIRS CERTIFICATION (RAC) EXAMINATION
RAPS is offering a free webcast from 12:00 to 12:45 pm EDT on Jan 11. This webcast will be Developing an RAC Study Plan. RAPS recommends this webcast for those interested in taking the RAC exam and for organizations planning an RAC study group.
Click on the link to the RAPS Webcast for more information.
2012 Study Groups & Exam Expenses Reimbursement Program
Offered by the San Diego Regulatory Affairs Network (SDRAN)
SDRAN is planning San Diego RAC Study Groups for those interested in preparing for the 2012 Fall or 2013 Spring US and EU RAC exams (or just learning more about the regulatory process). Study Group sessions are held on Tuesday (EU) or Wednesday (US) evenings from June to September in the Torrey Pines/Sorrento Valley/Del Mar Heights areas of San Diego. All classes start at 5:30 pm and last approximately two hours.
In addition, SDRAN also offers a RAC Exam Expenses Reimbursement Program to ten students who pass the 2012 Fall Exam and ten students who pass the 2013 Spring Exam.
Keep checking back for updates.
Other Courses of Interest
MS in Regulatory Affairs - SDSU San Diego State University offers both a Master of Science in Regulatory Affairs and a Certificate in Regulatory Affairs.
Clinical Trials Project Management Online Certificate Program - Cal State Fullerton offers a Certificate in Clinical Trials Project Management. The four courses are all offered online.
UCSD Extension University of Calfornia San Diego - offers Masters in Clinical Research and a number of certificate programs in clinical areas, project management, quality, manufacturing , and regulatory affairs.
MS Regulatory Science at USC - or call (323) 442-3524 University of Sothern California offers several programs including a Doctor of Regulatory Science, Master of Science in Regulatory Science, and certificate programs in clinical research, safety, and preclinical development.
Educational
Programs
SDRAN offers a variety of education programs to assist our members with their continued professional development. Learn more about our programs below.
SDRAN Mentoring Program
The SDRAN Mentoring Program is designed to help promote the career growth and development of our members, and to strengthen the regulatory affairs profession. This is an outstanding benefit provided to you as a member. To learn more, apply to the mentoring program, or to be a mentor click below.
SDRAN_Mentoring_Program_Description_General.pdf
Mentee Application.pdf
Mentee Announcement.pdf
Mentor Application.pdf
Mentoring Cohort.pdf
Browse our photo gallery and view pictures of our past events.
SDRAN posts job applications for regulatory, quality, and clinical positions for firms in Southern California.
Job Advert Instructions.pdf
Safety Syringes, Inc ., founded in 1990, is the industry leader in designing, manufacturing and marketing of innovative anti-needlestick devices for prefilled syringes to the Pharma Industry. Safety Syringes products reduce the risk of accidental needlesticks which can lead to the contraction of infectious diseases like HIV or Hepatitis C. Safety Syringes products are used in hospitals, physician offices and home settings all over the world. Customers of Safety Syringes, Inc. include Roche, Merck, Pfizer, Amgen, Johnson & Johnson, Teva and Novartis.
SR. REGULATORY AFFAIRS SPECIALIST
The Senior Regulatory Affairs Specialist, reports to the Vice President, QA/RA and will work closely with colleagues across a broad function area with responsibility for contributing to & implementing regulatory strategies for the US and Europe. This will be in support of multiple products from early development phases through registration & approval and post approval trending.
Specific responsibilities will include but not be limited to: 510(k) submissions, establishment registrations and listings, MDRs, MAF (device master file), assist customer in submission of combination product applications. This will further include: updating CE self certifying documentation, essential requirements files, assisting prepare risk management files and reports, design and process FMEA participation. Support for product development undertakings, e.g. clinical protocols, biocompatibility.
This position requires a Bachelors degree (BA/BS) from four-year college or university, and five to eight years related experience and/or training; or equivalent combination of education and experience. Experience should include medical device industry experience in domestic and international regulatory compliance. Regulatory Affairs Certificate (RAC) preferred.
Necessary skill sets include: 510(k) submission experience as well as assisting with Clinical Focus Group protocols and reports; CE self certifying documentation; Risk Management files and reports including participation in Design and Process FMEAs; MDR reporting; QSR and ISO compliance.
Safety Syringes, Inc. is an equal opportunity employer. Benefits include medical, dental and vision benefits, life and long-term disability insurance, paid holidays and vacation, and a 401(k) savings plan.
APPLY
For consideration please visit the Careers page on our website www.safetysyringes.com No phone calls please. Only local candidates need apply.
We are a growing organization known for outstanding products that have a real effect on our consumers. We seek a Quality Compliance Officer to join our team. In this role, you will maintain and improve the company's quality standards and systems while constantly adhering to GMP standards and Marketing Authorizations.
Responsibilities:
• Design, develop and manage quality systems and associated documentation to ensure compliance with regulatory standards
• Carry out internal and external audits in line with plan
• Act as lead auditor, to identify, action and close out all non-compliance issues
• Design and deliver cGMP and QS training in line with plan
• Maintain and update information on latest regulatory standards for use by company personnel
• Support continuous improvement of quality documentation to ensure compliance with cGMP
• Assist, prepare and complete product quality reviews to ensure compliance with regulatory expectations
Benefits:
We value our employees time and efforts. Our commitment to your success is enhanced by competitive pay of $40K annually and an extensive benefits package including paid time off, medical, dental and vision benefits, and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning and culture.
Qualifications:
Previous and significant industry experience within a quality assurance role, as well as substantial experience in auditing and GMP
Excellent communication and interpersonal skills
Extremely results driven and organized
Location: 4660 La Jolla Village Drive, Suite 900
Job Description
This position is responsible to monitor products and employee cGMP practices to insure the safety and quality of products in a growing medical device company. This position develops and maintains the company’s Quality Management System in accordance with regulatory and corporate requirements. .
Develop/maintain Standard Operating Procedures, Quality Process Instructions and Department Work Instructions per cGMP requirements
Works with production facility to ensure adequate quality controls are undertaken.
Provides training, as needed, and keeps track of individual training needs including follow up with department heads or supervisor.
Review and approve document change notice, Quality System procedures and Records.
Perform Internal Audits as a member of the Audit Team. Work with Audit Team to prepare audit reports. Track completion of audit responses and verify effectiveness of action taken.
Review/maintain non-conforming material process, corrective actions and other quality control documentation.
Conduct investigations into potential quality/compliance concerns. Keep management informed of issues.
Perform other duties, as assigned as required
Minimum five (5) years experience with a medical device or pharmaceuticals products company in areas of QA/QC
Bachelors degree (BA/BS) with emphasis in the physical sciences field (preferred).
In-depth knowledge of current FDA requirements plus hands on experience in complying with all elements of QSR requirements applicable to medical device distributor
Knowledge of cGMP requirements
Intermediate knowledge and experience with MS Word, Excel, Power Point and Access
Must have excellent organizational and team building skills, be extremely conscientious and have attention to detail
Ability to read, write and interpret documents such as safety rules, operating instructions, and procedure manuals
Application Information & Contact:
We offer a competitive salary package with generous benefits including health/dental/ vision, 401(k) and more!
Qualified applicants are invited to email their resume in Word or PDF format along with salary requirements to: hr_lmana.com
or by mail: LMA North America, Inc., 4660 La Jolla Village Dr., Suite 900, San Diego, CA 92122
or fax to 858-622-4144.
Reference job code 11-015
We are proud to offer equal opportunity and a culturally diverse workplace.
Trius Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibiotics for serious, life-threatening infections.
We are currently conducting Phase 3 trials for tedizolid phosphate (TR-701), an IV and orally administered second generation oxazolidinone, for the treatment of serious gram-positive bacterial infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). With the continuous increase in bacterial resistance to currently marketed drugs, serious infections are becoming more difficult, if not impossible to treat, and this has led to a clear need for novel therapeutics to treat multi-drug resistant bacterial infections.
Trius also has two ongoing preclinical programs using our proprietary discovery platform to identify and develop antibiotics to treat infections caused by gram-negative and grampositive bacteria. The GyrB/ParE program has identified new novel antibiotics soon to enter clinical trials.
Trius is seeking a Director of Regulatory Affairs to provide regulatory support for filing Investigational New Drug Applications (INDs) on behalf of these novel research antibiotics advancing to the IND-enabling stage and for providing regulatory support for the tedizolid phosphate development program.
Responsibilities
· Interact with responsible departments and lead preparation, review, and collection of documentation required for Investigational New Drug
Applications (IND) and other regulatory submissions
Develop and manage regulatory project specific timelines, in keeping with Corporate objectives
Contribute to the writing and editing of regulatory documents
Provide critical review of all documentation supporting regulatory applications
