ASQ-LA Quality News
ASQ LA SECTION 0700
November 2012
In This Issue
November 14th MEMBER MEETING
Message from the Chair
Best Quality Practices Article
CERTIFICATION EXAMS
ASQLA Leadership Team
Greetings!

 

Welcome to the November Issue of the ASQ-LA Newsletter.

Looking forward to see you at our November 14th Member Meeting @ Phenomenex 2341 West 205th Street  Torrance, CA 90501. If you plan to attend the meeting, YOU MUST RSVP to Chen Low 310-334-7044, pager 310-353-8293 or e-mail ChenLow_88@hotmail.com, no-later-than Noon on Monday, November 12th, so he can get the list of attendees.
 

Do not go to the Phenomenex main entrance on 411 Madrid. The Meeting will be on the 2nd floor of 2341 West 205th Street. Near Crenshaw and 190th. 

 
Looking forward to your attendance at this month's program.
 .
Harold Martinez
Newsletter Chair
ASQLA
 

  

ASQLA MEMBER MEETING - November 14, 2012
    

 

"The Value of an ASQ Certification-Panel Discussion" 
 

Please join the ASQLA Section 0700 for its monthly member meeting on Wednesday, November 14th. The meeting will be at Phenomenex 2341 West 205th Street in Torrance Our November 2012 meeting will feature a number of our senior leadership team members leading a panel discussion on how ASQ certifications have helped develop great careers. Panelists will include Dr. Catherine Martin, Past Chair Joe DeSimone, and current Chair Lane Parrott.

 
ASQ certification is a formal recognition by ASQ that an individual has demonstrated a proficiency within, and comprehension of, a specific body of knowledge. Nearly 150,000 certifications have been issued to dedicated professionals worldwide.

 

 

The panel will discuss the importance and value of certain ASQ certifications. In most cases, a certification offers the most value when it is held by a professional whose job duties most closely align with the certification. Many quality professionals still find themselves at career crossroads or are seeking new positions inside or outside their organizations. Some may be deciding they want a change: more pay, more responsibility or more interesting work. For others, employers are making the decision, forcing employees to switch jobs or shift career directions because of cutbacks or closures. Regardless of what's driving the change, many quality professionals hold valuable assets in the form of certifications that can be used to find new jobs and transition careers.

  

The panel will explore how can job seekers gain an edge, better manage their transitions and leverage certifications to their advantage. How can certifications increase a job seeker's bargaining power when screening potential employers? Certification holders-or those thinking about obtaining certifications-should know that these assets make them more attractive to potential employers.

  

Invest in your career and your future with an ASQ certification. Gain an advantage over your competition and increase your potential for a higher salary. The panel will discuss finding the certification that's right for you and the process for receiving ASQ certification.

 

Dr. Catherine L. Martin holds a Bachelor of Arts in biology from the College of St. Catherine, St. Paul, Minnesota, Master of Science Degree in Quality Systems Management from National Graduate School in Falmouth, Massachusetts and Doctor of Business Administration in Quality Systems Management from National Graduate School in Falmouth Massachusetts. She is currently employed at Raytheon in El Segundo, CA and is certified as a Quality Auditor (CQA) and Quality Engineer (CQE) by the American Society of Quality.

 

Joe DeSimone is President of DeSimone Engineering Inc, International Consulting for Quality and Productivity with offices in US and China and conducts ASQ Review Courses since 1990. Joe has successfully certified over 4000 ASQ members Internationally. Joined ASQ in 1985 Senior member 1991. Joe holds certifications as CQE, CQT, CRE, CSSBB, CMQOEM, CHAACPA, CQI, CSQE, BSIE, Master Blackbelt, PMP, AS9100 Lead Assessor; Fellow IAIE. Joe's prior ASQLA Positions as Chair, Vice Chair, Certification Chair since 1991. 

 

Lane Poor Parrott holds a Bachelor of Science in Business Management from Babson College, Wellesley, Massachusetts. Lane's diverse career spans 32 years, 8 companies and 4 states. Some of her positions were: Plant Foreman, TQM Coordinator, Lube Plant Manager, QMS Consultant, Loan Officer and Financial Advisor. Lane is certified as a Quality Auditor (CQA), Quality Engineer (CQE) and Six Sigma Black Belt (CSSBB) by the American Society of Quality. Lane is the Quality Assurance Manager for Phenomenex in Torrance, CA. 
 

The program will be held at 2nd Floor Main Conference Room at Phenomenex 2341 West 205th Street Torrance, CA 90501. This meeting is an opportunity to network with other Quality Professionals, learn about quality related topics and earn 0.3 Recertification Units. Registration and networking starts at 5:30 PM. The meeting runs from 6:00 to 7:30 PM. Crackers, Cookies, Coffee & Water will be provided at no charge.

 

You MUST RSVP to Chen Low 310-334-7044, pager 310-353-8293 or e-mail ChenLow_88@hotmail.com, no-later-than Noon on Monday, November 12th, so he can get the list of attendees.

 

 

Message from the Chair - Lane Parrott

 

This month I would like to share with you an opportunity to get involved and make a real difference in someone's life. On the 16th and 17th of November, over 700 Phenomenex USA employees, friends, family, ASQ Members and community members will come together to pack 150,000 meals to feed thousands of starving children in the developing world. Phenomenex has sponsored 100% of the event costs, including funding the 150,000 meals and providing the facilities, volunteer gifts, and the considerable investment of employee hours for planning and volunteering, all of which are estimated to reach well into six figures. Phenomenex sponsored a smaller event in 2010, where we produced 130,000 meals for starving children in North Korea . My daughter and I enjoyed it so much that we worked 4 shifts!
 

We invite you to our Torrance, California headquarters to help pack these meals by signing up for a brief, impactful 2-hr volunteer shift. Join Us  
. I hope to see you at our next meeting.

 

Lane Parrott

Section 0700 Chair
LaneP@phenomenex.com
310-489-9018

 

 For information on placing an ad through ASQLA, contact Advertising Chair at (310)383-2393, awang@spectrumchemical.com.

 

 

 

Best Quality Practices for Biomedical Research in Drug Development

By  A. Mark Trotter1, Rick Calabrese2, Li-Chung Huang3, Alice Krumenaker4, Ulo Palm5


 

 Good Manufacturing Practices (GMP) and regulatory guidelines ensure the 'safety, identity, strength, quality, (and) purity of drug(s). Manufacturing and quality control testing of approved drugs falls under these GMP regulations. Interestingly, for the drug discovery processes and biomedical research activities, there is a paucity of guidelines or regulations governing their quality practices. Due to this lack of quality guidance, there is often time and effort unproductively spent on biomedical research drug studies that require replication for verification. A working group from the American Society for Quality (ASQ) Food, Drug and Cosmetics Division (FD&C) has published its first technical report addressing the need for biomedical research quality practices and standards. The following commentary provides background and commentary on this ASQ-FD&C Technical Report.

 

Therapeutic drug products touch our lives daily in innumerable ways. Starting with the nutraceuticals we take to supplement our diets and the analgesics we take for common ailments to the cardiac and cancer treatment medicines for serious illness, these drug products enter into our everyday lives. The public's hopes have been nurtured by the expectations provided by biomedical research and drug development. Governmental and private funding provides the support for drug discovery to help cure human illness and suffering. One aspect all drug manufacturing processes have in common is the government regulations known as Good Manufacturing Practices or GMPs. These regulations can all be found under their respective sections of the US Code of Federal Regulations Title 21 CFR Parts 210, and 211. Similar documents exist globally; WHO and in European and Asian Pharmacopoeia. In pharmaceutical research and development, only laboratories performing clinical safety studies are governed by the Good Laboratory Practices (GLP) CFR Part 58. There are no other well-defined quality practices or standards existing for non-GLP laboratory research, including biomedical research that may lead to new drug discovery.

 

The proportion of the global drug development pipeline belonging to research organizations based in the United States has increased to 80% in the past decade. In the U.S. about $68 billion per year is spent on biomedical research.1 Hastily designed experiments coupled with the irreproducibility of biomedical research data and studies have the consequence of drug companies pursuing a therapeutic development dead-ends. This outcome has become an increasingly serious issue. The credibility of this biomedical research has lead to costly and often futile attempts to replicate these studies. The efforts to confirm and duplicate these defective studies often result in an inexcusable misuse of scarce, valuable funding and time resources.

 

A White Paper published by The National Center for Dissemination of Disability Research supports this concept...' the widespread belief that the quality of scientific research is often uneven and lacking in credibility, making it difficult to make a confident, concrete assertion or prediction regarding evidence for improving practice or consumer outcomes (Levin & O'Donnell, 1999; Mosteller & Boruch, 2002; Shavelson & Towne, 2002). ...is also due, in part, to the lack of consensus on the specific standards for assessing quality research and standards of quality for assessing evidence (Gersten et al., 2000; Mosteller & Boruch, 2002). For example, several researchers have contended that some of the current peer review processes and standards for assessing quality are not well suited for research in the disability arena (Gersten et al., 2000; NCDDR, 2003; Spooner & Browder, 2003).2

 

Notwithstanding the doubling of biomedical research funding and the shift toward clinical research by pharmaceutical companies,...' the number of new molecular entities approved by the FDA has fallen...as a consequence, pharmaceutical productivity decreased over the last 10 years, and it is lagging behind that of the biotechnology and device sectors...' 3. Obstructions to new drug entity breakthroughs have received much scrutiny since the recent decade-long decline in new drug approvals. There has been an overall significant decline of productivity in pharmaceutical biomedical research over the past 15 years when comparing the number of new medicines to the equivalent funding spent in R&D, Figure 1.

 

A venerable tradition in scientific publications is the peer review of the study results. However, as the latest biopharmaceutical research has grown in complexity, often requiring in-depth specific knowledge, that general peer review has a diminished role today. Also,' ...some scholars suggest that while standards such as peer review and standardized reporting are important benchmarks, research should not be judged solely by whether or not it is published in the leading journals (Boaz & Ashby, 2003). While journal publication and citation analysis provide quantitative data, it is a faulty assumption that all "research" that is published in journals or cited by others is accurate, reliable, valid, free of bias, non-fraudulent, or of sufficient quality (Boaz & Ashby, 2003). Further, citation analysis is primarily a measure of quantity and can be artificially influenced by journals with high acceptance rates' (COSEPUP, 1999).4

 

Modern biomedical research is moving scientific research out of the realm of individuals to globalized teams wherein quality practices / standards and reproducibility become key requirements. Scientific work that cannot be reproduced or independently verified is a squandering of valuable capital and time resources. Additionally, to prove the authenticity, integrity, and reproducibility of the data and experiments, they should be conducted under controlled and verifiable conditions. One of the root causes for the reproducibility problem is this lack of common quality practices for non-regulated biomedical research.

 

The ASQ FD&C 'Best Quality Practices for Biomedical Research in Drug Development' technical report can provide the guidance for creditable and reproducible work without hindering the essential creative environment in basic research. This quality guidance can lessen or eliminate the duplication of research work, make published study data more reliable and enhance the productivity of biomedical research. These quality practices can benefit patients by speeding novel drugs to market, meet regulatory drug requirements, augment investor interest in developing innovative drug product that produce the necessary return on investment.5

 

Summary of Technical Report Content & Scope 7-12

The FD&C Division of ASQ has published a technical report, Best Quality Practices for Biomedical Research in Drug Development, ASQ TR1-2012, which addresses the need for biomedical research standards (6). This Technical Report specifies the quality requirements for non-regulated biomedical research in drug development, Figure 2.  The scope and intent is to ensure credibility and reproducibility of these biomedical research studies. This includes both large and small molecule discovery and non-clinical development that is not covered by GxP.

The target audience for this report is the scientific staff at institutions and companies involved in drug development and biomedical research. The following summarizes the major sections covered in detail in the aforementioned technical report.

.

Management system

Management of the research institution shall establish and document policies and procedures for its activities. Management shall ensure appropriate organizational structures, resources and processes to implement, maintain, and continuously improve the quality system.  

 

Organization

The research institution shall: have necessary authority and resources to perform duties and responsibilities, policies restraining external influences, protection of intellectual property, accountability of data /reports, effective, independent Quality Management Systems, and proper facilities and equipment to perform study.

 

Project Management

The research program should follow good management practices: well defined work structure, tracking and communications reporting progress /performance, change control for study objectives and outcomes.

 

Quality Management System

Management shall establish, implement and maintain a quality management system (QMS) appropriate to the scope of its activities. The QMS established must be capable of ensuring reproducibility of biomedical research results to support effective drug development, e.g., deviation management, self-inspections (audits), research review, internal review, external reviews.

 

Documentation

Study plans, procedures, and activities shall be documented in writing to assure data quality, integrity, authenticity, and reproducibility. Research institutions shall therefore establish and maintain procedures to control all documents that prescribe how studies and experiments are to be conducted and describe how studies and experiments were conducted. Documents can therefore be divided into two broad classes:

Prescriptive documents, which give specific instructions on how a study or experiment is to be conducted, e.g., Standard Operating Procedures, (SOP).

Descriptive records, which describe what was actually done and what happened during the course of a study or an experiment, e.g., Data / Reports / Lab Books /Publications.

 

Document control / Document approval and issue:

Research institutions must establish procedures for the control of prescriptive and descriptive documents. Procedures must include a formal review, approval, and distribution policy such that only the most recent approved documents are available for staff use. In addition, such procedures must include the following:

 

Document changes:

The research institution shall establish and maintain a change control process for impact, repeatability, approval, traceability, and implementation. Training must be documented.

 

Document storage

Documents shall be stored in a secure and suitable environment that provides confidentiality and prevention from loss, deterioration and destruction. Retention times shall be established and, if applicable, be in compliance with appropriate laws and regulations.

 

Technical Requirements:

Personnel: Training is critical to develop and maintain competence; all personnel should be made aware of the importance of training and its impact on the quality objectives. Research institution management shall ensure that those staff assigned to perform research activities has the appropriate combination of education, experience, and training to be competent with their assignments.

 

Facility and Infrastructure: The research institution shall have facilities and equipment sufficient for the conduct of the study and to maintain the infrastructure. Infrastructure includes; buildings and workspace, utilities, storage areas, computer and communications networking, safety equipment.

 

Test Equipment:

 

Equipment Design - Equipment shall be designed, located and maintained to suit its intended purpose and meet good practices, cleaning calibration, validation etc.

 

Test methods / Method Validation:

Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled. Validation of methods used in a research institution is critical for the integrity and authenticity of study results.

Sampling and Chain of Custody:

Adequate and correct sampling is critical for ensuring that the sample taken is a true representative of the whole. The research institution shall therefore have a sampling plan and procedures for collecting samples of substances, materials, or products for subsequent testing.

Materials:

Receiving, handling, and storage: The handling, storage, and types and quality of materials used in the conduct of biomedical research can affect the outcome of the research.

Test articles, control articles, and test systems: The purity, concentration, and stability of test articles and control articles (where used) can greatly affect the outcome and repeatability of a study or an experiment. Therefore, the purity, concentration, and stability and storage of test articles and control articles shall be specified and evaluated and documented periodically following standard operating procedures.

 

Legal and Ethical Considerations:

All personnel involved in biomedical research activities are to act in an ethical manner. Examples of non-ethical behavior include but are not limited to: Plagiarism, Fabrication, selective / biased data reporting, financial / external influencing of study results. Protection of intellectual property - an understanding between the parties regarding ownership of intellectual property. In addition, a non-disclosure agreement may be established to ensure that the confidential nature of the study and study results are maintained.

Vendor Selection and Qualification:

Research institutions may outsource a portion of their research activities to a third party. The subcontracted work may be subject to the research institution's quality system. As such, care must be taken to place such work with a competent subcontractor. The research institution shall have a policy and procedure(s) for the selection and purchasing of services and supplies it uses that affect the quality of its research work.

 

 

 

Authors:

  1. A.Mark Trotter, MS, MBA, President, Trotter Biotech Solutions, Inc.
  2. Rick Calabrese, Global Corporate Director Quality Systems, Sartorius Stedim Biotech
  3. Li-Chung Huang, Chair ASQ-Philadelphia Section, Process design/improvement expert
  4. Alice Krumenaker, Manager R&D QA, CorePharma.
  5. Ulo Palm, MD, PhD, MBA, Sr.VP Clinical Operations & Biometrics, Forest Research Inst.

 

 
 

ASQ Certification Exams

 

Application Deadline

April 12, 2013

 

Late Application

Fee ($50) Deadline

April 17, 2013

 

Exam Date

June 1, 2013

 

Certifications

 

Quality Engineer(CQE)

Quality Auditor(CQA)

Six Sigma Green Belt (SSGB)

Software Quality Eng. (CSQE)

Quality Improvement Assoc (CQIA)

Calibration Technician(CCT)

Quality Process Analyst (CQPA)

 

Application Deadline

January 11, 2013

 

Late Application

Fee ($50) Deadline

January 16, 2013

 

Exam Date

March 2, 2013

 

Certifications   

 

Six Sigma Black Belt(SSBB)

Mgr of Qual/Org Excel (CMQ/OE)

Quality Inspector(CQI)

Quality Technician(CQT)

Biomedical Auditor(CBD)

Reliability Engineer(CRE)

HACCP Auditor(CHA)

 

 CALL ASQ HEADQUARTERS:

800-248-1946

or

www.asq.org

for more information.

 

Cal State Dominguez Hills BSQA & MSQA Programs

sponsor certification preparation courses, See certification

page on www.asqla.org.

 

Is it time for recertification?

Send your package to Joe DeSimone,

Recertification Chair at

P.O. Box 1291, San Pedro, CA90731.


 
 

ASQ LA LEADERSHIP TEAM

MEETING SCHEDULE

Time: 5:30 - 6:00 Networking & Dinner

6:00 - 8:00 Meeting

Location:

CSUDH Extended Education Bldg

1000 Victoria St., Carson, CA 90745

Contact: Lane Parrott, Chair

(310) 489-9018

laneP@phenomenex.com,

Dates: 1st Wednesday of the Month

_______________________________________________________________ 

  

2011-12

Officers & Committee Chairs of ASQ Los Angeles Section 700

www.asqla.org

 

CHAIR: Lane Parrott - (310) 489-9018 - laneP@phenomenex.com

VICE CHAIR: Andrea Reilly - 310-617-6764 - andreareilly6@aol.com

SECRETARY: Catherine Martin - 310-616-0936 Catherine_Martin@raytheon.com

TREASURER: Jim Morrison -(310) 541-1417 - jamamorr@aol.com

PAST CHAIR/Executive Advisory: Chen Low - (310) 334-7044 - chenlow_88@hotmail.com
Arrangements:  Chen Low - (310) 334-7044 - chenlow_88@hotmail.com

 Job Listing: Armen Yeghoian- 818-912-9272 - Armen2049@yahoo.com

Website Chair: Crystalyn Nield- (310)462.1150- Crystalyn@wcfb.cc

Membership: Lisa Uhrig - - 310-283-1197 lisa@uhrigconsulting.com

 Education: Bill Trappen - (760)723-7718 -tankerwht@aol.com

CSUDH Liaison: Milt Krivokuca - (949) 892-7994 - Milt619@cox.net

Certification: Joe DeSimone - (424) 772-6371 -jrdesimone@msn.com

Re-certification: Joe DeSimone - (424) 772-6371 - jrdesimone@msn.com

Newsletter: Harold Martinez - (310) 214-1606 -martinez2004@verizon.net

Awards and Recognition: Imre Fischer -(949)493-3914 - imrefische@aol.com

Quality Management Process (QMP): Crystalyn Nield- (310)462.1150- Crystalyn@wcfb.cc

Financial Audit: Michael Schaffer - (310)895-0802  michaels@psychemedics.com

Simon Collier Quality Award:  Imre Fischer - (949) 493-3914 ImreFische@aol.com

    Programs: Andrea Reilly - 310-617-6764 - andreareilly6@aol.com

Publicity & Advertising Chair: : Alan Wang - (310)383-2393 - awang@spectrumchemical.com