The President’s Message...Roundtable Minutes 6-7 First Quarter Meeting Registration Form 8...

Volume 17, Issue 1 March 2006

A Publication of the North Carolina Chapter of the Society of Quality Assurance

In This Issue...

President’s Message 1

Executive Council Updates 2-5

2006 NCCSQA Roundtable Schedule 4

Roundtable Minutes 6-7

First Quarter Meeting Registration Form 8

RQAP-GLP Study Group & Form 9-10

Featured Articles 11

Opportunities 12

Corporate Sponsors 13-14

2006 NCCSQA Membership Application 15

I would like to extend a warm welcome to all of the Current and New Members of the NCCSQA for the 2006 Year. We were very fortunate to elect some great additions to the Board this year and I would like to personally welcome Celine Clive (Programs), Beth Furr (Bylaws), Evangelia Evdaimon (Issues and Methods), and Stu Mertz (President-elect) and thank Rich Patterson (Past-president), Toddie Stewart (Programs) and Lisa Olson (Bylaws) for their time and effort during their time with the Board. The Program Committee is working hard to develop some very good programs with interesting speakers and the Issues and Methods Roundtable Discussion has set its schedule of great topics for the year. Please feel free to forward your suggestions and topics to the Program Committee and they will try to do their best to accommodate your requests. As the President of this Society, I will ensure that we will do everything in our capability to provide knowledge and enhance the learning process for the NCCSQA Members. Let’s make 2006 the best year ever. Respectfully Yours, Guy Gardner

The President’s Message

by Guy Gardner

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QA Communiqué March 2006 QA Communiqué March 2006

2006 NCCSQA Executive Council

President

Guy Gardner

(919) 483-5445 phone

(919) 315-0969 fax

[email protected]

President Elect

Stuart Mertz

919-602-8568 phone

919-462-0724 fax (phone first)

[email protected]

Past President

Edie McMillan

(919) 483-6836 phone

(919) 315-0969 fax

[email protected]

Treasurer

Ellen Colclough

(919) 620-2261 phone

(919) 620-6366 fax

[email protected]

Secretary

Cathleen Rubens

(919) 362-4738 phone

[email protected]

NCCSQA BYLAW AMENDMENTS APPROVED All proposed amendments to the NCCSQA Bylaws were overwhelmingly approved in December by the membership. The new version of the NCCSQA Bylaws incorporating these amendments became effective on January 12, 2006, and is available to members on the NCCSQA Website. Of the 241 ballots mailed, 95 ballots were returned and counted. The voting results for each Bylaw Amendment follows:

Article VI – Administration, Section 5: The Chapter Executive Council shall authorize the disbursement of all funds except that the Treasurer may make disbursements of $500.00 or less after receiving a proper invoice or receipt.

Yes: 92 No: 3

Article VII – Meetings, Section 3: If decisions are to be made or votes to be taken on official Chapter business at a special meeting, a quorum consisting of 20% of the Chapter members in good standing is required. Alternatively, decisions can be made by mail ballots.

Yes: 95 No: 0

Article IX – Committees, Section 5: The Membership Committee also makes an annual Chapter Membership Directory available to Chapter members.

Yes: 95 No: 0

Article XI – Amendments, Section 2, delete the requirement for SQA approval of amendments before amendments may become effective.

Yes: 91 No: 3

(Note: There was also 1 ballot returned without a vote on this amendment)

Election Results…….. Late each summer, the Past President of NCCSQA is responsible for chairing the Nominations Committee, and this year was my turn. Linda Borkowski and David Brodish served on the Nominations Committee with me. They did a fantastic job of finding outstanding candidates for each of the available positions on the 2006 Executive Council. Approximately, 40% of our members voted, and following are the results of the election: President-Elect: Stu Mertz, PEAK Quality Consulting Program Committee Co-chair: Celine Clive, Polaris Clinical Research Bylaws Committee Chair: Beth Furr, Quintiles Transnational Issues & Methods Committee Chair: Evangelia Evdaimon, InfoStrength Guy Gardner, GSK, advances from President-elect to President (continued on page 4)

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QA Communiqué March 2006

The First Quarterly Meeting of 2006

is scheduled for the afternoon of March 14 in the Elion Hitchings Building Auditorium at GlaxoSmithKline, 3030 Cornwallis Rd. in Research Triangle Park.

Keys to Writing Effective GxP Standard Operating Procedures (SOPs)

The program will include:

tips that apply to all GxP areas, by Celine Clive, President of Polaris Clinical Research Consultants, Inc.

a panel discussion of similarities and differences among GCPs, GLPs, and GMPs led by Nancy Benson of Benson Consulting with George Waterhouse, President of BioPharm Compliance, Inc., Lisa Zimmerman, Vice President, Quality Assurance at POZEN, Inc., Lysa Triantafillou of Charles River Laboratories, and Eddie Balance of Eisai, Inc.

break-out sessions in which participants will evaluate a sample SOP facilitated by Stuart Mertz, Jr. President of PEAK Quality Consulting, Inc., Jim Ussary, President of Ussary Scientific Services, Inc., Betty Hyatt a QA consultant in GLPs, Lysa Triantafillou of Charles River Laboratoreis, Nancy Benson, of Benson Consulting and Eddie Balance of Eisai, Inc.

The program will be from 1:00 until ~ 5:00 pm. Registration is being held open through March 09.

To register, phone or e-mail one of the Program Committee Co-chairs: Betty Hyatt @ 919-847-9972 Celine Clive @ 919-463-0003

Email - [email protected]

You can find more meeting details on our web site NCCSQA.ORG We hope to see you there.

Education and Programs Committee 2006 NCCSQA Executive Council

Educ/Prog. Co-Chair

Betty Hyatt

(919) 847-9972 phone

[email protected]

Educ/Prog. Co-Chair

Celine Clive

919-463-0003 phone

919-463-0004 fax

Membership Chair

Patrick Sabourin

(919) 622-6057 phone

[email protected]

Bylaws Chair

Beth Furr

919-998-2563 phone

[email protected]

Issues & Methods Chair

Evangelia Evdaimon

(919) 573-6132 phone

[email protected]

Publicity Chair

Michelle Holbrook

(919) 462-4888 phone

(919) 654-0865 fax

[email protected]

919-998-1415 fax

[email protected]

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QA Communiqué March 2006 QA Communiqué March 2006 QA Communiqué March 2005

We currently have 169 members. We have about 81 members who have not renewed their membership.

For those who have not renewed yet, please do so very soon. We do not want you to lose the benefits of being a member. If we do not receive your renewal by 24 Feb 06, you will no longer have access to the member section of the website and will therefore lose the associated privileges.

Membership

Issues & Methods Date Topic March 14 Dealing with "reluctant" management. What can QA do?

April 11 “I’d Never Do That Again” – Sharing Regulatory Inspection Anecdotes and Scenarios

May 9 Impacts of outsourcing and off shoring – QA Effects.

June 13 Validation for OTS (Off the Shelf) computer systems.

July 11 Reorganization and the impact for the QA department. Experiences and suggestions on how to overcome challenges.

August 8 SOP development – Keeping pace with evolving practices and new technologies

September 12 Fear of documentation – How can we overcome it?

October 10 Critical Audit Observations – Escalation and Follow up

November 14 Comparing Software Quality Practices – CMM vs. GAMP

December 12 N/A

2006 Roundtable Schedule

These new members joined the Executive Council at its first 2006 meeting in January. I know each of the Executive Council members will effectively lead NCCSQA in 2006. They cannot, however, do it all by themselves. They need the support from volunteers (yes, that is you). Consider volunteering to help where your interests could lead you to run for office in the future. Finally, I want to thank Linda and David for volunteering to serve on the Nominations Committee and for all of their hard work. Personally, I was very pleased by the slate of candidates we presented to the membership for consideration. Rich Patterson

(continued from page 2)

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WANTED: Chapter Members Willing to Share Betty Hyatt

Are you going to SQA Annual Meeting in April 2006? If you are, are you willing to share what you

learn with fellow NCCSQA members after you return? The Program Committee needs your help at the second quarter meeting in presenting the latest hot topics, the concerns and trends from the Agencies, the best tip you heard on solving issues that plague us all. Many of our chapter members won’t be able to attend this year and would greatly appreciate your giving a brief synopsis of your favorite session. No need to prepare a long speech.

Please contact Program Co-Chairs, Betty or Celine, if you are interested in helping.

2006 NCCSQA QA Communiqué Schedule

Deadline 1st Quarter 2nd Quarter 3rd Quarter 4th Quarter Submittal Feb 10 May 12 Aug 11 Oct 24 Publication Feb 24 May 26 Aug 25 Nov 7

The NCCSQA Member Scholarship enables a member to attend a pre-conference training session at the annual SQA meeting (or SQA training when held in the Triangle), and be reimbursed for up to $500. The recipient must meet the following eligibility requirements: 2006 NCCSQA member Be able to attend the annual SQA meeting or Triangle area training. Submit a review of the training to be published in a future NCCSQA Communiqué.

To apply: Submit name, address, phone and email address to

the President, Guy Gardner at [email protected] by 5:00p.m. on March 10 for entry into a drawing.

2006 NCCSQA SCHOLARSHIPS

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NCCSQA Roundtable Minutes

10 January 2006 Issues and Methods Roundtable Minutes Challenges with Keeping Staff Qualifications Documented and Current

The discussion mainly was around the maintaining of accurate training records including CVs and job descriptions in regards to:

How to ensure these important records are kept up-to-date and reviewed on a consistent basis by per-forming an annual review. One suggested they be updated during the employee annual performance review period.

Documenting these reviews and approvals by including a documentation form to sign or to actually sign or date the document at each review were the two methods most often used.

Handling resistance to the process was difficult to manage in many cases. Management was not always involved in training record review but left it up to the employee and management put no consequences on the employee for non compliance

Development of SOPs to manage training records to include how the documentation of review was performed including exactly what was to be included in each person’s file.

Some companies are researching the use of electronic training record management systems. Not much detail on the exact system was given; however, the software that one company was looking at was validated.

Roundtable Dialogue Notes GCLP – Contrasting the Academic Environment with an Industry Lab

Several agencies and organizations were referenced during the discussion. Links to more information can be found at the end of this document

The facilitator is involved with an analytical lab supporting Phase I/II NIH sponsored clinical trials.

NIH requires these labs to be “GLP compliant”. NIH is using this to maintain consistency between multiple laboratories

Is the lack of a national accreditation body an issue? (continued on page 7)

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NCCSQA Roundtable Minutes Continued

February 14, 2006

Facilitator – Marcella Sarzotti-Kelsoe

BARQA does have GCLP guidelines (Good Clinical Laboratories Practices)

Elements of GCLP:

• Organization and Personnel • Facilities • Equipment, Materials, Reagents

• Standard Operating Procedures • Study (Analytical Plan) • Conduct of the Work

• Data Reporting • Quality Assurance • Computerized Systems • Storage and Retention of Records

• Confidentiality

FDA does not require laboratories analyzing clinical samples to be GLP compliant

It was asked if CLIA was the equivalent of GCP. The general opinion was no.

True GLP compliance isn’t possible, no study director exist. Additionally, GLPs apply only to non-clinical studies

South Africa has a national accreditation body, SANAS. SANAS uses OECD GLPs as the accreditation standard

Facts about GCLP compliance in the research academic environment:

• Mind set in academia different from industry

• Records/documentation not structured • Endpoint assays not validated • No proficiency testing program available • Quality assurance unit often mixed with laboratory units (QA not independent from study

|conduct)

• Part 11 compliance made difficult by institutional rules • Absence of an accreditation body in US compared to international sites

(continued from page 6)

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First Quarter Meeting Registration Form

Keys to Writing Effective GxP Standard Operating Procedures

NCCSQA 1st Quarterly Meeting – March 14, 2006

GlaxoSmithKline Elion-Hitchings Building, Main Auditorium

3030 Cornwallis Road Research Triangle Park, NC

12:30 -- 1:00 pm Registration

1:00 -- 1:30 pm Welcome and Introduction

1:30 -- 2:30 pm Presentation: Master Keys to Writing SOPs in GCP, GLP, GMP

2:30 -- 2:45 pm Break

2:45 -- 4:00 pm Panel Discussion: SOP Similarities and Differences Among the GxP Areas

4:00 -- 5:00 pm Break-out Sessions: Evaluation of Sample SOP in GxP Area GCP, GLP, or GMP

There will be a drawing for a free membership to NCCSQA for 2006. You must be present to win.

- - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - - - - - - -- To register, you must e-mail your registration information to NCCSQA by March 09, 2006 @ [email protected]. Name: _______________________________ Company: ___________________________ Phone: _______________________________ E-mail: _____________________________ Address: ________________________________________________________________________ ________________________________________________________________________ Indicate one (1) break-out session you wish to attend: GCP:_________GLP:________GMP:_________ Member Non-Member

Program only $40____ $55_______ 2006 Membership $15_______* Total Enclosed $_________ If joining NCCSQA, please fill out the 2006 Membership Form Check if you are an SQA member: Active:_________ Affiliate:__________ RQAP-GLP certified?: Yes ______ No ______ Detach the bottom portion of this page, include check payable to NCCSQA with name of registrant, and mail to:

NCCSQA P. O. Box 14274

Research Triangle Park, NC 27709

*NCCSQA Membership (If you are joining at this meeting, you may pay the member rate for the meeting. Your total will be $55) .

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RQAP-GLP Exam Information

NCCSQA RQAP-GLP Examination Preparation Series

NCCSQA will offer the RQAP-GLP exam in the Triangle-area in both 2006 and 2007. NCCSQA has

developed a study program for members planning to take the SQA RQAP-GLP exam in April.

Below are the topics and dates of the study sessions: each session is scheduled from 6:00 to 7:30 PM.

March 1 - Auditing

March 8 - Break/Weather make-up session, if necessary

March 15 - Scheduling and reporting

March 22 - Record-keeping and documentation

March 29 - Evaluation and advising

April 5 - Review

April 12 - Review (if necessary)

April 22 - Exam date

There is no charge for the study group, but it is only open to 2006 members of NCCSQA. To register for

the study group, please complete the registration form and return it to Guy Gardner. If you decide to

return it by mail or FAX, please notify Guy by e-mail for planning.

Guy Gardner

NCCSQA President and GLP Study Group Chair GSK

5 Moore Drive - 5.4749

RTP, NC 27709

Phone 919-483-5445

FAX 919-315-0969

[email protected]

The application deadline for taking the RQAP-GLP exam is March 4, 2006.

See http://www.sqa.org/newsite/public/rqapglp-exam.asp for more information.

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RQAP-GLP Study Group Registration Form

Registration for RQAP GLP Study Group

Return your completed registration form to: Guy Gardner NCCSQA President and GLP Study Group Chair GSK 5 Moore Drive - 5.4749 RTP, NC 27709 Phone 919-483-5445 FAX 919-315-0969 [email protected]

Name:

Company:

Address:

City: State: Zip Code:

Phone:

E-mail:

Area(s) of expertise:

Area(s) in which you work:

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Featured Article

Programs – Looking Both Ways Betty Hyatt

This year I’m looking both ways. Not only before I cross the street. I’m looking back at the programs from 2005 and looking forward to those in 2006. Last year, which was the first year of my 2-year term as Program Co-Chair, was a learning curve for me. Program Co-Chair Toddie Stewart got me off to a good start. Lots of NCCSQA members, especially the Executive Council, pitched in to help. They answered my endless questions, volunteered to help, or just showed up when help was needed. This year I better understand the process for making an idea become a program. In 2005 we had educational pro-grams at 3 quarterly meetings then ended the year with a holiday celebration on a crisp, breezy day in December. On that day there was plenty of time for networking, seeing old friends, learning little-known tidbits about other celebrants, dining on a plentiful buffet, and enjoying the talents of a professional pianist. Looking into 2006, we welcomed an enthusiastic new Program Co-Chair, Celine Clive, who will be speaking during our first quarterly meeting ”Keys to Writing GxP Standard Operating Procedures.” The meeting will be held on March 14 and will include Celine’s presentation followed by a panel discussion on similarities and differences between SOPs used in the various GxP areas. The last part of the program will be an exercise evaluating sample SOPs guided by seasoned pros. You probably have already received the announcement for the March 14 meeting. If so, please register soon. Pass along the information to your quality assurance/quality control colleagues and to others who will likely need to prepare SOPs, if especially if the folks are novices to SOP preparation. This year members of the Executive Council will be working on programs, as usual, along with Linda Borkowski and Shelly Woody. We will continue to call on our Chapter members and others to contribute in various ways. We have reviewed the comments participants made on the surveys after each educational meeting last year. The Program Committee looks forward to three educational meetings and the holiday dinner. Maybe there will be some surprises, as well. This year, help us look both ways; we know what has been presented lately but want to look forward. Please continue to let us know your topics of interest.

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Opportunities

Quality Assurance Auditor (Job Code 00051)

Rho, Inc., a quality-focused Contract Research Organization located in Chapel Hill, NC seeks a QA Auditor. Will perform QA audits under the direction of the Director and Assistant Director. Responsibilities include writing audit plans and reports, assisting with evaluating compliance with company procedures, policies, programs, and initiatives. GCP and ICH knowledge and experience required. Minimum of two years hands-on experience with clinical trials preferred. Excellent organizational, verbal and written communication skills required. Ability to prioritize effectively and work independently as well as with an audit team considered essential. Must be able to multi-task and possess a strong detail-orientation. Bachelor's degree is required. Please apply by submitting your resume and cover letter with salary requirements to our website at www.rhoworld.com/hr. Rho is an EEO/AA employer.

ANTECH DIAGNOSTICS 507 AIRPORT BLVD, SUITE 113 MORRISVILLE, NC 27560

Phone: (919) 277-0822 Fax: (919) 277-0825

Part-Time QA Auditor A part-time (12-20 hr/wk) is needed for Antech Diagnostics Clinical Pathology GLP lab. 1 year of GLP experience preferred. Training provided. Flexible hours. Please contact: Katie Powell, QA Auditor Email: [email protected]

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QA Communiqué Notice The QA Communiqué is only being distributed in electronic form unless a paper copy is specifically requested by the member. You will need Adobe Acrobat to open the file. If you want to receive a paper copy please e-mail the Publicity Chairperson @ [email protected] with your request. You may also use the Member’s Only section of the website to access the Newsletter Archive.

REMINDER

NCCSQA gives a free 2006 NCCSQA Membership at each Quarterly Meeting as well as

a free 2007 SQA membership at the 4th Quarter meeting.

NCCSQA Thanks Our Corporate Sponsors

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NCCSQA Thanks Our Corporate Sponsors

Are you interested in advertising your job postings at our Quarterly Meetings? If so, please contact the program chairpersons at least one week prior to the meeting to find out if and where you can post your fliers at the meeting. You may contact Betty Hyatt or Celine Clive at their e-mail ad-dresses or by phone.

Betty Hyatt e-mail: [email protected] Celine Clive e-mail: [email protected]

RTP Corporation 975 Walnut Street, Suite 324, Cary, NC 27511 (919) 622-2116 Kathleen D. Andrews, Managing Director RTP Corporation provides FDA and EPA regulatory compliance consulting services. Resources and expertise are available to evaluate and establish regulatory compliant laboratories and programs including regulatory inspection assistance and Consent Decree management.

Specialties are Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) program management including audits, inspections, training and SOP development.

Visit the RTP Corporation website at www.rtpcorp.org.

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NNORTH

CCAROLINA CCHAPTER of the SSOCIETY of QQUALITY

AASSURANCE

OUR MISSION

To disseminate current information on regulatory policies and trends, provide multi-facetted educational

opportunities, and to act as a resource for our members who are

respected quality assurance professionals.

Please send this completed application with $15.00 dues to:

NCCSQA P.O. Box 14274 RTP, NC 27709

TIN # 56-1127594

2006 Application for NCCSQA Membership

For more information, see www.nccsqa.org

Name: Title: Company: Address: City: State: Zip code: Telephone: (____) Fax: (____) E-mail: Area of Expertise (you may select up to two categories): Category: GLP GMP/QSR GCP 21 CFR Part 11 Arena: FDA Drugs EPA FDA Devices FDA Animal Health Scope of interests (you may select more than one category and arena): Category: GLP GMP/QSR GCP 21 CFR Part 11 Arena: FDA Drugs EPA FDA Devices FDA Animal Health SQA Member: Active Affiliate Not Certifications: RQAP CQA CQIA RAC Other (specify):

The President’s Message...Roundtable Minutes 6-7 First Quarter Meeting Registration Form 8...

Documents

Transcript of The President’s Message...Roundtable Minutes 6-7 First Quarter Meeting Registration Form 8...