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ustacud, "how do i really feel" ? Some times i think we need to take a step back from everything, a bit of a rest, away from things and then come back, to begin again. A rest period then on ward to make strong our Tolerance level our sence of compassion always trying to grow in our patience.But always keeping care that standards are up held and the line is not crossed.
mingwan0,I agree, this problem is where it all started for me long ago on the rb board as hopeful107.How some try to make mischief when all you were trying to do was to share and help.Mingwan0,since then i had to contend with jealousy,resentment,suspicion,paranoid, envious posters all for the sharing of info.Since, i dont like being called a lier i defended my self only to run into walls of egotism,self-centeredness,incorrigible,cynical,erroneous,subliminal,arrogance.I was then asked to show more Patience,by those who were not on the receiving end. But you are right here the posting of any info. will be increasingly problematical. There are many more ,many more reasons why people are here then just for the sake of sharing knowledge in order to move in a pos. direction. There are groups or teams of posters here who are out to discredit both Dnap and those who support Dnap.This is not the class room where people come to learn it is very different,oh there are some who come to learn But there are many more who are here for another reason.The circle never ends.Sooner or later standards ofthe board will be compromised via attrition.Or if you will, you will be compromised via attrition, is it worth it ?
Chig, all products at Dnap that recieved outside funding are not subject to the Orchid agreement, per Carrie and Tony and the filings.
ustacud,ok thanks.
billyboy, there you go again,attacking other posters.You start with a complement to a targeted person,than attack with pointing the finger at others and judgemental statements and name calling with, "Gcbr has a alcohol problem". Your whole post ignores what Dougs has been trying to say along.STOP the PERSONAL ATTACKS but you feel its ok to ignore the rules.IS there something about this you dont get. Stop THE PERSONAL JUDGEMENTAL ATTACKS yet you continue. What dont you get ?
billyboy, Denial is a favorite of the rebel along with acting like the savor and protector of "innocent posters" who know no better.Poor innocent posters getting beat up - Really man !! what a line, its old hat.Again trying to control others in support of you with subliminal messages.You work these subliminal messages like a pro. like spook maybe, ya right.
Billycal;
You are right of course. Its better to go solw and get it right the first time.I've seen comp.'s go to fast to get on the market and suffered great sets backs because they skipped over certains Reg.'s. Their pps went from dollars to pennys and took over 2 years for it to climb back up.The SEC put "Stop Halts" on the trading of the comp., investors bailed out it was a mess.All because the comp. tryed to market a product before getting market approval {FDA} on a Med. devise.It may be true that other comp.'s will come out before us on one thing or another but did they skip anything ??? I think maybe they did. And will their product hold up to the valldation efforts made by countless people who for one reason or another are out to prove them wrong and will use every means possable to discredit the product.Tonys is bulding a Mountain of statistical evidence that will hold up in any court in the land, by the book and this sets well with me.Once the pps starts to go up i dont want anything to come along and bang us back down.
This is what Accreditation for Dnap is all about. http://www.epa.gov/ttnnela1/arcstand/nelac_plus_17025.pdf
accreditation in the U.S is no joke.
Another good source - http://www.epa.gov/ttnnela1/arcstand/nelac_plus_17025.pdf
General Requirements for the Competence of calibration and yesting of Laboratories - ISO/IEC/EN 17025.See The web site.
http://www.fasor.com/iso25/
The Evolution of Guide 25 into ISO Standard 17025
By Daniel D. Hoolihan
TÜV Product Service (New Brighton, MN)
Accreditation of EMC laboratories has taken on increasing importance in the last several years. This development has resulted in part from FCC's decision to allow self-declaration of personal computer emissions as a legitimate, even preferred, procedure for conformity assessment—if the testing is performed at an accredited laboratory. This emphasis on accreditation has become formalized with the rising importance of mutual recognition agreements between the United States and the European Union and between the United States and the Asian-Pacific Economic Community.
Currently, the relevant document for lab accreditation is the ISO/IEC Guide 25, "General Requirements for the Competence of Testing and Calibration Laboratories."1 Reflecting the increasing worldwide importance of this subject, Guide 25 is now being revised as ISO Draft International Standard 17025, using the same title.
More than 123 pages of comments were received from interested parties from around the world in response to the latest draft (number seven) of the new standard. Working Group 10 of the ISO Conformity Assessment Committee (CASCO) met in March 1999 to resolve technical and administrative issues arising from the many comments. The latest version of the Draft International Standard (DIS) 17025 should be released for final vote in the summer of 1999. If all goes well, the new standard could be in the marketplace by first quarter 2000.
Two much-debated issues in the draft standard are tolerance testing or guardbanding and measurement traceability. The first issue addresses the prevention of false acceptance of out-of-tolerance measurements, while the second issue is important for calibration traceability. (The United States voted against the latest draft of 17025 because it didn't like the wording of section 5.6 on measurement traceability.)
In general, the requirements in the draft standard are more mandatory in nature than the recommendations of the guide. The organization of the draft standard has changed to reflect this difference. That is, as discussed below, the main body of the standard is divided into three parts: initial requirements, management requirements, and technical requirements.
Initial Requirements of ISO 17025
The opening sections of 17025 are entitled Introduction, Scope, Normative References, and Terms/Definitions. The introduction is similar to the Guide 25 introduction in that it refers to ISO 9001 and 9002 and specifies that certification to those standards does not necessarily demonstrate technical competence. Of course, technical EMC competence is the key to producing technically valid testing results.
The section on scope is very similar to that of Guide 25. It specifies the general lab requirements and the organizations to which it is applicable, including first-, second-, and third-party laboratories. The normative references include ISO/IEC Guide 2, VIM, ISO 9001, and ISO 9002. The terms and definitions section includes best measurement capability as the only definable term, and it only applies to calibration labs. This section also references ISO/IEC Guide 2, VIM, and ISO 8402.2
Management Requirements
This section covers the basic material and content of ISO 9001: 1994. The management requirements of DIS 17025 are very similar to those of ISO/IEC Guide 25 and EN 45001. Few changes have occurred in the area of lab operational guidelines from an administrative perspective.
4.1 Organization and Management. This section of 17025 stresses the fact that "the lab can be held legally responsible." The lab must be organized so that it can carry out its work at permanent or temporary facilities. If the lab is part of a larger organization, the responsibilities must be carefully divided to avoid conflicts of interest.
The lab must have management and technical personnel with the authority and resources needed to do the EMC testing. The lab personnel must be free from any undue pressures that could adversely affect the work. The lab must have policies to protect the clients' confidential information and they must have an organizational chart that specifies the interrelationships of all personnel. The lab must also have a technical manager and a quality manager.
4.2 Quality System. The lab management staff must establish a quality system and document the lab's pertinent policies and procedures. The quality system will be recorded in a manual that includes a policy statement by the chief executive.
4.3 Document Control. The lab must have procedures to control all documents that are part of its quality documentation. A master list of issued quality system documents must be kept by the lab. Changes to documents shall be reviewed and approved by the same authority performing the original review.
4.4 Review of Report, Tenders, or Contracts. The lab shall establish and maintain procedures for the review of requests, tenders, or contracts.
4.5 Subcontracting of Tests and Calibrations. Work may be subcontracted to competent subcontractors for special tests requiring extra technical expertise.
4.6 Purchasing of Services and Supplies. The lab shall use only such services and supplies that are at a level of quality sufficient to create reliable test results.
4.7 Service to the Client. The lab shall allow clients to monitor the performance of the lab during the EMC testing process.
4.8 Complaints. The lab shall have a policy and appropriate procedures for resolving customer complaints.
4.9 Control of Nonconforming Testing Work. The lab shall have procedures to implement when its work does not conform with its own procedures or the agreed upon requirements with the client.
4.10 Corrective Action. The lab shall have a policy for implementing corrective action when departures from technical procedures have been identified.
4.11 Preventive Action. Opportunity for needed improvement shall be identified and the necessary action plans should be developed and implemented.
4.12 Records. The lab shall have procedures for quality and technical records including security and confidence measures.
4.13 Internal Audits. The lab shall periodically (in accordance with a predetermined schedule) perform internal audits of its activities.
4.14 Management Reviews. The executive management of the laboratory shall periodically review the lab's operations to ensure continuing suitability and effectiveness.
Technical Requirements
Measurement uncertainty is stressed more heavily in the draft standard than in Guide 25. All other technical sections of the two are very similar.
5.1 General. Seven technical factors (5.2 – 5.8) contribute to the total conformity of measurement of the laboratory.
5.2 Personnel. The technical personnel must be qualified for each specific test on the basis of appropriate training, education, experience, or demonstrated skills. The lab shall maintain current job descriptions for all personnel.
5.3 Accommodations and Environmental Conditions. Lab facilities shall allow current performance of EMC tests by appropriate separation of emission and immunity test areas.
5.4 Test Methods. The lab shall use appropriate test procedures including estimation of measurement uncertainty. The lab shall have instructions on the use and operation of all relevant test equipment.
5.5 Equipment. The lab shall have all necessary test equipment for performing the EMC tests in its scope of accreditation. Records shall be maintained on lab equipment, especially the calibration histories.
5.6 Measurement Traceability. All equipment shall be calibrated before being put into service. The calibration must be traceable to the Systems International (SI) units of measurement. Calibration certificates shall include measurement uncertainty.
5.7 Sampling. When a lab does EMC sampling, it must have a plan and procedure for the sampling process.
5.8 Handling and Transportation for Test Items. The lab shall have procedures for transporting and handling test items including procedures for marking and identifying the test items.
5.9 Assuring the Quality of Test Results. The lab shall assure the quality of results by monitoring test results using statistical techniques and other established methods.
5.10 Reporting the Results. The test results shall be reported accurately, clearly, unambiguously, and objectively in the form of a test report or a test certificate.
Conclusion
The organization of DIS 17025 emphasizes the distinction between management requirements and technical requirements for an accredited laboratory. Because the technical requirements are called out in explicit detail, a lab that complies with ISO 17025 is essentially also ISO 9001 compliant. By contrast, a lab certified to ISO 9001 may or may not also comply with the technical criteria of ISO 17025.
References
1. International Organization for Standardization, ISO/IEC Guide 25: "General Requirements for the Competence of Calibration and Testing Laboratories," 3rd ed., Geneva, 1990.
2. International Organization for Standardization, ISO 8402: "Quality Management and Quality Assurance—Vocabulary," 2nd ed., Geneva, 1994.
Back to 1999 Annual Reference Guide Table of Contents
Billycal,
Talking to others, who in one way or another have a working relationship w/Dnap is a great way to find out whats really going on at Dnap.But - Warning - Warning - Warning !!! If you should learn the inside dope on Dnap from another soruce AND you should share it on the message board than before the day is out that source will be gone,gone, GONE !!! This is a VERY HARD lesson to learn.There are many reasons for this 1}there are some at Dnap who read this board. 2}There are some here who dont believe what you post so they contact Dnap about it and once done,your inside source is gone 3}There are close friends and relatives of Dnap who read here.
The sad thing is no matter how much you know you cannot say anything here or even E-Mail someone about it. Because others cant be trusted, should there be a leak, your source is gone and having a source to inside info. is worth its weight in gold. You also can take some heat from posters here about pumping the stock - Mr. know it alls.You see its not just keeping confidential Dnap's request on info. its also safe garding your sources. These are 2 very big reasons to not say anything and as you know there are others.
Have a great day
ustacud,it is a great country !!! Yes and united we stand. Go Dnap
Billycal,
In a way i'm glad info. leaked out espically by the locals. I really think at times its good for Dnap that it does.I may get in trouble for saying this, i may not, but a great deal can be learned by going through the back door rather than the front and in some places the Back door is open to many more than the front.As you say it was the locals who spiled the beans but they are not the only ones. LOL There are others !!!
chrisbaskett, yes indeed. Dnap is what we are all here for.To da moooooooooooonnnnnnnnnn.LOL
Miss Scarlet, perhaps i was a bit strong in my choice of words with you and as such there are some who would say i was wrong. But are we not directed by our Lord to not lie, about others, to not bear false witness against your neighbor.When i read your post i was offended because i held you in high regard, i always enjoyed your posts.So feeling "wronged" i too struck a blow. But madam your post was as wrong in Gods eyes as was mine. I am not perfect and will fight with the best of them if the cause is right and thats fine with me. perhaps we need to start over, perhaps you need to think about what you have posted, as i have done.
God Bless
Miss Scarlet your full of it. I know what you said and there is only one way to look at it. END of story
Billycal,
I've been asked by some at Dnap to keep info. confidential. I am very sorry but i must respect the request made of me. I know Dnap is receiving many requests by Police and Dept.'s all over the country. Some are on Big cases while others are on small cases and all bring in revenue for the comp. It takes time for the word to get out and believe me its working.Due to the nature of the Forensic business and criminal investigations the safe keeping of info. given is a testimonial and declaration of Dnap's ability to handle cases entrusted to them in a Confidential way. This is very good for business.Without this reputation established were dead in the water. Good things come to those who wait.
Have a good night.
Billycal... Knowing that our comp. has world wide interest sets very well with me, the sooner the better.
I am privy to limited info. and Dnap is involved with other police Dept. but not in Cal. alone,but more in the North east as well.
The 8 Million is a lot of money no matter how they receive it. If they were to only get half of this amount i think it would be enought to jump start any cold Battery.
We have done very well invested in this comp. You know the hardest part is first to find the gold,once found then its just a matter of time before its out of the ground and in the bag.Its here we found the gold, the hard part is over.
Billycal, did you know that Dr. Benjamine Li who is an advisor to PRB Pharmaceuticals is also CTO with Lee Pharmaceuticals.And with Lee's agreement with Zengen there does in deed seem to be something big going on,maybe in Europe, sounds good to me.
God Bless
Chrisbaskett... You had me and my kids and wife rolling on the floor. Thats a good one.LOL Got to go out and remove some snow see ya.
Here are a few more on Hector Gomez was/is also on the board of Vertex Pharmaceuticals and VP for Medical Affairs there.
Also Ciba- Geigy,executive Director.
Cellgenica - Chairman/ president.
Hold tight - Stand Strong - We will be All Rich, soon !!!
W2P...Thats what happens when you have a Big nose.LOL, Thanks
Hector Gomez was/is on the board of directors with Phase 5 Sciences that used to be called "Beverly Glen Medical".PRB Pharmaceuticals also had Hector Gomez on the board AND has has exclusive distribution Rights as of April,2003 with Lee's Pharmaceuticals {who are a public comp.}
Zengen Inc. also has a Lic. aggrement with Lee Pharmaceutical effective 7-15-02. Hector Gomez is/was on the board of Zengen who have a working aggrement with Dragon Venture. Hector Gomez is /was on the board of Saneron CCEL; Semaphore; Life Sciences; Zengen; Clinication; Genbiomics; Phase 5 Sciences; PRB Pharmaceuticals; and Dnap and who knows what else.
Big things will happen here count on it.
Next stop nasdaq - Now we going to the moon !!! Good buy OTC
Now they will be able to afford to get on Nasdaq. Say good buy to otc.It should be very soon.
stakddek, thankyou I could not have said it better.
Bandersnatch12, the DA will call the shots here. My guess is Venkateswarier will have such pressure put on him that his choices will be few; 1} tell us what we want to know and your out in 5 years or 2} keep your mouth shut and do 20.
winbig911,thanks,my guess is any action that some one takes that breaks the law and a judge gives orders to confiscate their property lost their right with certain and many institutions. It is my guess rb wants to work with law enforcement especially when its at this level. This guy did a bad thing and will most likely go to jail for it. The standard must be set an example must be made.
Mjam, I told him and listed all the posts he did and sent them to all comp. officers.
winbig911,i agree,but my feeling is that, that process can take as long to put togeather in another country as the FDA process here. Although other countrys dont have FDA rules and Regs to contend with they have its equal with bribe,hireing certain people who are related to certain people and all the other things that you would go to jail here for.There is always an exchange, you get away with one thing but have to contend with something else.Yes Dnap doesn't need FDA approval in other countrys BUT they will still have to contend with their system and ways of doing Business.
Retro,this is just another BIG question that is hard to answer. But as much as i wish it were not true,I have to agree with you by the next run up we will know the answer to the hireing of these comp. officers, a short time should tell or answer the question as to Why.
Good luck
Chris, I will stick around. I stand strong with you with respect to the Forensic project at Dnap. Eye color should be out soon, but hair color and the rest looks like will be a while end of 2004 or end of 2005. I agree with you when you say "The longer it takes DNAP to stake their claim the smaller that 'steak' will be." Very good point. Good luck to you.
I will not be posting much anymore in light of the most recent developments at Dnap. In light of the projected Time table from the Wall Street Transcript,and the filings it is clear nothing Big will be comming for a very long time. I will of course read at times the message boards. Over the last 3 years I have learned a great deal from all of you and want to say thankyou. I will keep my position with Dnap all the way but it is clear to me that we are now at least over a year away from anything Big happening to move the pps.Stockholder Equity is projected to be $12 Million in 2006 and not much at all before this. Tony indicated not much money will be spent for the rest of the year 2003. The web site says "STATINOMETM is projected to enter clinical studies for FDA approval by late 2004 or early 2005". This tells me we are years away from FDA approval,2007 or 2008 maybe longer. I dont mean to sound Negative but these are the facts. I wish all here the very best and Dnap. God Bless and hope I'm wrong.
Stakddek, Thanks. I did not see the earlobe & Height so I'll go back and look for it.And i will hang in there, where else can i go. Long and strong.
bigdrive99, Im', sorry if you only new what I will have to deal with because of all this and my family it might help you understand a little better my frustation. I will try to be more Positive next time.
On Ovarian for God's sake what does this mean -
"Once funding sufficient to screen 250 patients at $1,000 per patient is received, OVANOMETM will be tested in clinical trials for monitoring and reporting on the use of Taxol and Carboplatin. Our Chief Medical Officer, Hector J. Gomez, MD, PhD will lead the clinical development process."
Is this 250 patients just the beginning because thats the # for phase 1 trials and that would mean Ovarian will be years away.
Or is the 250 patients just a final testing ground for a completed product.
And we have to wait for FDA to play catch up where it says in another part of the web site that the FDA wont be ready till 2005 on approving classifiers
THIS SUCKS IM, SORRY I though 2004 maybe 2005 and we have a FDA approved product now it looks like were just starting once we get to 2005.
Good luck everyone
Statnome 7al years away, look at this from the web site.
{STATINOMETM is projected to enter clinical studies for FDA approval by late 2004 or early 2005.}
It is projected to ENTER clinical studies in 2005 - To ENTER - Is this for real oh man forget it.You Know late 2004 REALLY MEANS 2005 and were just starting clinical studies - Shit
Gcbr,I thought they were going to have PD pay for each of the tests seperatley. If it comes all in one test or DNA package than it would be one price ? Anyway, I think i understand what your getting at. Thanks