ÐÏ à¡± á > þÿ I K þÿÿÿ H € ÿÿÿÿÿÿÿÿÿÿÿÿÿÿ ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿì¥Á 7 ð ¿ bjbjU U -8 ÿÿ ˜ 7| 7| ° D l ÿÿ x ä x ä x ä x 8 ˜ ÿÿ ˜ ( D • • ª3 ˜ C0 • • ° Û X0 ° 0 • ž0 0 ì x Ž 0 0 " 0 ° ˜ • C0 w w 0 w w À • 7 0 x Ž Š ° 0 • x w w w ° 0 x µ, • Š1 ‹ $ ° @ ° ¸ / ˜ à ˜ ° l €ê¡¢çøà Рä Z Ñ- " / n0 0 ž0 óB4 w B4 / w ¬ < è , x x x x Ù User Information Plan Template Form Rev. Feb 05, 2002 Document Information: Filename FILENAME \* MERGEFORMAT USERINFO.DOC Current Owner Deborah Perkins Product Identifier H2297A (Cerity A.02) Project Identifier SS030154 Current Lifecycle Phase Release Revision Log: Version Date Reason For Update A.00 May 27, 2003 Initial user information plan. A.01 February 21, 2004 Update Product Availability Date: February 21, 2004 for A.02.02 Localization Plans: Japanese Product Release Bulletin Available(location): EPI Warehouse Course Description: This two-day lecture and laboratory course is designed for those Cerity Pharmaceutical QA/QC operators who will have full access to the software including method development tasks. The topics covered include advanced topics in reprocessing, building custom queries, integration, peak identification, quantitation, custom sample variables, custom calculations, system suitability, report templates, sequences, instrument details, and Agilent 1100 software specifics. H2296A is a prerequisite for this course. Course Deliverables: Powerpoint slides for instructor presentation Word modules for each presentation Word manuals, student and laboratory manual Pdf of student manual and laboratory manual Pdf of instructor manual with userinformation plan. There are not many instructors notes. All known information is either provided in the student notes or in the “Preparations” section of the laboratories. Course Outline with correlation to filenames: 1. 2. Result Review 01_resultsreview.ppt/.doc Laboratory Exercise: Results Review 01_labresultreview.doc 3. Queries 02_querywizard.ppt/.doc 4. Laboratory Exercise: Query Wizard 02_labquerywizard.doc 5. Integration 03_integration.ppt/.doc 6. Laboratory Exercise: Integration 03_labintegration.doc 7. Compound Identification 04_peakident.ppt/.doc 8. Advanced Quantitation 05_advquant.ppt/.doc 9. Laboratory Exercise: Compound Identification, Calibration, and Quantitation 05_labquant.doc 10. Sample Variables 06_samplevariable.ppt/.doc 11.Custom Calculations 07_customcalc.ppt/.doc 11b. Custom Calculations (2nd half) 07_customcalcb.ppt/doc 12. Laboratory Exercise: Custom Calculations 07_labcustomcalc.doc 13. System Suitability and Limits 08_suitability.ppt/.doc 14.Report Template Editor 09_reporttemp.ppt/.doc 15.Laboratory Exercise: Report Template Editor 09_labreporttemplate.doc 16.Advanced Sequencing 10_advsequence.ppt/.doc 17.Instrument Details 11_instrumentdetail.ppt /.doc 18.Agilent 1100 HPLC 12_agilent1100.ppt/.doc 19.DADAcquisition 13_DADAcq.ppt/.doc 20.DAD Peak Purity 14_DADPurity.ppt/.doc 21.DAD Peak Confirmation 15_DADConfirm.ppt/.doc Note: 19, 20, and 21 are optional for those students who have the DAD with spectral capabilities. Instructor or Delivery Agent skills and training required prior to product delivery: The instructor must be able to set up a Cerity NDS Pharma QA/QC professional system. The instructor must have command of the following Cerity features: developing Cerity methods, sample entry, sequence entry, running samples and sequences, result review and reprocessing, integration, acquisition method parameters, DAD spectral features and accept/reject. In addition, the instructor must be able to create custom calculations, custom variables, custom queries, and report templates. The instructor must be able to set up and maintain and Agilent 1100 Series HPLC. The instructor must also know common maintenance and tests for the Agilent 1100 Series HPLC such as detector intensity test, pump ripple, etc. 5. Instructor Set-up To avoid extra work, install a series of professional systems, two students per system. Use the Installation Manual found on the EPI warehouse for Cerity NDS for Pharmaceutical QA/QC to install the professional systems. You can make one image of a professional system and copy to each required computer in the classroom. It is much more difficult to set up in a client/server environment as you cannot duplicate usernames and passwords. Also, problems may occur with customers trying to access the same methods at the same time. The subjects the students are learning in this course are not compromised by the use of professional systems. The minimum hardware for a professional system is: Pentium III, 40 GB, 512 MB memory, display 1024 x 768. Agilent 1100’s are not required for this course. The data systems with restored data are the only required instrumentation. Follow the instructions in the Cerity Installation manual to install a professional systems. Create an NT and Cerity user that has administration rights for the students to use. If you have professional systems, you can use the same name and password for each student pair. In the Cerity Software administration add the database on each professional system. Add the following licenses: PharmaQC Client Certificate Id = 227718958 License Code 1=15883188 License Code 2=1112809637 Cerity GMP Module Certificate Id = 253930026 License Code 1= 15630315 License Code 2 = 1381245605 You do not need a spectral license to process spectral data, just to acquire it. Create users for the students and give them all rights (administrator). Explain that they may not have all rights in their laboratory. You will need to provide the students with their usernames, passwords, and database name before the first laboratory exercise. There is a place in the laboratory exercise for them to write down the information. Add printers. The report template laboratory requires the use of printers. Restore the data for this course. The data is found in the EPI warehouse. Search for the course, H2297A. Download the zipped file, archive2297a.zip. Restore the sequences first, then the samples. Consumables Required for Delivery : None Electronic files required for product delivery: Restore the data provided using the archive and restore utility. You need only restore sequences and samples. The methods will restore with the sequences. Tools required for product delivery: No tools are required. Laboratory Preparation Instructions: Restore sequences and samples Activities required during product delivery: Cerity software is complicated. Check on students to make certain they are not having problems during the lab exercise. Activities required after product delivery: Please forward any comments to Deborah_perkins@agilent.com. PAGE PAGE 1 Agilent Technologies For Internal Use Only ! 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£ ¤ ¥ ¦ § ¨ © ª « ¬ ® ¯ ° ± ² ³ ´ µ ¶ · ¸ º þÿÿÿ» ¼ ½ ¾ ¿ À Á  à þÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ:displayName="P roduct Group" ma:description="Select only the Product Group that is the primary focus of this publication." ma:hidden="true" ma:internalName="ProductGroup"> <xsd:complexType> <xsd:complexContent> <xsd:extension base="dms:MultiChoice"> <xsd:sequence> <xsd:element name="Value" maxOccurs="unbounded" minOccurs="0" nillable="true"> <xsd:simpleType> <xsd:restriction base="dms:Choice"> <xsd:enumeration value="Atomic Spectroscopy"/> <xsd:enumeration value="Automation Solutions"/> <xsd:enumeration value="Bioreagents, Standards &amp; Kits"/> <xsd:enumeration value="Columns &amp; Supplies"/> <xsd:enumeration value="Dissolution"/> <xsd:enumeration value="Electrophoresis"/> 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K e y w o r d s _ P I D _ H L I N K S " ; d i s p l a y _ u r n : s c h e m a s - m i c r o s o f t c o m : o f f i c e : o f f i c e # P u b C o n t a c t # P u b C o n t a c t $ L i b r a r y U r l % C o u n t r y & W e b P a g e D e s c r i p t i o n ' R e l a t e d P a r t N u m b e r ( C o n t e n t T y p e I d ) M i d C a t * M a i n C a t ° 0 H 2 2 9 7 A A . 0 2 . 0 2 L S C A - 0 0 - 0 3 3 - 0 0 0 3 6 6 0 9 U n i v e r s a l M S O f f i c e T r a i n i n g M a t e r i a l 2 0 0 6 - 0 2 - 2 2 T 0 2 : 1 4 : 0 0 Z 3 6 6 0 9 0 H 2 2 9 7 A ; C e r i t y D . P e r k i n s A 1 4 0 E n g l i s h - U N I n f 2 1 T S f o r p r e P h a I T E D S T A T E S ; # S o f t w a r e & o r m a t i c s ; # 2 0 0 4 - 0 2 0 0 : 0 0 : 0 0 Z ; # D a t a S y s t e m s ; # 2 d a y a d v a n c e d c u s t o m e r t r a i n i n g C e r i t y P h a r m a Q A / Q C ; H 2 2 9 6 A i s - r e q u i s i t e . ; # S m a l l M o l e c u l e r m a c e u t i c a l s & G e n e r i c s ; # T h i s t w o - d a y l e c t u r e a n d l a b o r a t o r y c o u r s e i s d e s i g n e d f o r t h o s e C e r i t y P h a r m a c e u t i c a l Q A / Q C o p e r a t o r s w h o w i l l h a v e f u l l a c c e s s t o t h e s o f t w a r e i n c l u d i n g m e t h o d d e v e l o p m e n t t a s k s . T h e t o p i c s c o v e r e d i n c l u d e a d v a n c e d t o p i c s i n r e p r o c e s s i n g , b u i l d i n g c u s t ; # C e r i t y C h e m ; # L E B E R , B I L L ( A L i t t l e F a l l s , e x 1 ) ' ; # I n s t r u m e n t C o n t r o l & D a t a H a n d l i n g ; # ‰ h t t p s : / / e x t r a n e t . c h e m . a g i l e n t . c o m / W o r k s p a c e s / T r a i n i n g / P u b l i c / 0 3 6 6 0 9 , h t t p s : / / e x t r a n e t . c h e m . a g i l e n t . c o m / W o r k s p a c e s / T r a i n i n g / P u b l i c / 0 3 6 6 0 9 u h t t p s : / / e x t r a n e t . c h e m . a g i l e n t . c o m / L i b r a r y / T r a i n i n g / P u b l i c , h t t p s : / / e x t r a n e t . c h e m . a g i l e n t . c o m / L i b r a r y / T r a i n i n g / P u b l i c O 0 x 0 1 0 1 0 0 9 F 5 C 1 4 F 1 C F 5 8 4 7 C 7 Portable Leak Detectors"/> <xsd:enumeration value="Prep LC"/> <xsd:enumeration value="Preparative Columns"/> <xsd:enumeration value="Prep-Process Benchtop LC Detectors"/> <xsd:enumeration value="Prep-Process Benchtop LC Fraction Collectors"/> <xsd:enumeration value="Prep-Process Benchtop LC Injectors"/> <xsd:enumeration value="Prep-Process Benchtop LC Systems"/> <xsd:enumeration value="Prep-Process Benchtop LC Valve Solution"/> <xsd:enumeration value="Prep-Process LC Pumps"/> <xsd:enumeration value="PrepStat"/> <xsd:enumeration value="Process LC Systems"/> <xsd:enumeration value="Processing Hardware"/> <xsd:enumeration value="Protein"/> <xsd:enumeration value="Protein Sequencing"/> <xsd:enumeration value="Protein System"/> <xsd:enumeration value="Proteomic Consumables"/> <xsd:enumeration value="Proteomics Accessories"/> <xsd:enumeration value="Purospher Columns"/> <xsd:enumeration value="Robotic Automation"/> <xsd:enumeration value="Rotary Vane Pumps"/> <xsd:enumeration value="RPS Series Roots Pumping Systems"/> <xsd:enumeration value="RRHT"/> <xsd:enumeration value="Sample Device"/> <xsd:enumeration value="Sample Filtration"/> <xsd:enumeration value="Sample Introduction"/> <xsd:enumeration value="Sample Preparation"/> <xsd:enumeration value="Sampling Systems"/> <xsd:enumeration value="SampliQ QuEChERS"/> <xsd:enumeration value="SampliQ SPE"/> <xsd:enumeration value="Search"/> <xsd:enumeration value="Selective Detector"/> <xsd:enumeration value="Small Molecule System"/> <xsd:enumeration value="Software"/> <xsd:enumeration value="Software Compliance"/> <xsd:enumeration value="SPE (Solid Phase Extraction)"/> <xsd:enumeration value="SPE Cartridge Reservoirs and Stopcocks"/> <xsd:enumeration value="SPE Method Development Kits"/> <xsd:enumeration value="Specialized"/> <xsd:enumeration value="Spectrometry Data System"/> <xsd:enumeration value="Spectroscopy Data System"/> <xsd:enumeration value="Spin Concentrators"/> <xsd:enumeration value="Spin Filters"/> <xsd:enumeration value="Spin Tubes"/> <xsd:enumeration value="Superspher Columns"/> <xsd:enumeration value="SureSelect"/> <xsd:enumeration value="Synthesizer"/> <xsd:enumeration value="Syringe Filters"/> <xsd:enumeration value="Syringes"/> <xsd:enumeration value="Systems"/> <xsd:enumeration value="Thermostat Column Compartments"/> <xsd:enumeration value="TMR 8900"/> <xsd:enumeration value="TMRAqua70"/> <xsd:enumeration value="Transducers"/> <xsd:enumeration value="Turbo Pumping Systems"/> <xsd:enumeration value="Turbo Pumps"/> <xsd:enumeration value="UV-VIS Accessories"/> <xsd:enumeration value="UV-VIS Compliance"/> <xsd:enumeration value="UV-Vis Standards &amp; Reagents"/> <xsd:enumeration value="UV-VIS Systems"/> <xsd:enumeration value="UV-VIS-NIR"/> <xsd:enumeration value="Vacuum Manifolds, Parts and Accessories"/> <xsd:enumeration value="Vacuum Supplies"/> <xsd:enumeration value="Vacuum Technologies"/> <xsd:enumeration value="Vials"/> <xsd:enumeration value="VS Series Automatic Leak Detectors"/> <xsd:enumeration value="Workstations"/> <xsd:enumeration value="X-ray Source"/> <xsd:enumeration value="ZORBAX"/> </xsd:restriction> </xsd:simpleType> </xsd:element> </xsd:sequence> </xsd:extension> </xsd:complexContent> </xsd:complexType> </xsd:element> <xsd:element name="Product" ma:index="26" nillable="true" ma:displayName="Product" ma:hidden="true" ma:internalName="Product"> <xsd:complexType> <xsd:complexContent> <xsd:extension base="dms:MultiChoice"> <xsd:sequence> <xsd:element name="Value" maxOccurs="unbounded" minOccurs="0" nillable="true"> <xsd:simpleType> <xsd:restriction base="dms:Choice"> <xsd:enumeration value="G2912A"/> <xsd:enumeration value="G2613A"/> <xsd:enumeration value="G2614A"/> <xsd:enumeration value="G2630A"/> <xsd:enumeration value="G2630B"/> <xsd:enumeration value="G2855B"/> <xsd:enumeration value="G2888A"/> <xsd:enumeration value="G2913A"/> <xsd:enumeration value="G2916A"/> </xsd:restriction> </xsd:simpleType> </xsd:element> </xsd:sequence> </xsd:extension> </xsd:complexContent> </xsd:complexType> </xsd:element> <xsd:element name="IndustryGroup" ma:index="27" nillable="true" ma:displayName="Industry Group" ma:description="Select only the Industry Group that is the primary focus of this content." ma:hidden="true" ma:internalName="IndustryGroup"> <xsd:complexType> <xsd:complexContent> <xsd:extension base="dms:MultiChoice"> <xsd:sequence> <xsd:element name="Value" maxOccurs="unbounded" minOccurs="0" nillable="true"> <xsd:simpleType> <xsd:restriction base="dms:Choice"> <xsd:enumeration value="BioPharma"/> <xsd:enumeration value="Clinical Research"/> <xsd:enumeration value="Energy &amp; 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Flavors"/> <xsd:enumeration value="Forensics"/> <xsd:enumeration value="Fuel Cells"/> <xsd:enumeration value="Genomics"/> <xsd:enumeration value="Homeland Security"/> <xsd:enumeration value="Hydrocarbon Processing"/> <xsd:enumeration value="Nucleic Acid Analysis"/> <xsd:enumeration value="Production-QA/QC"/> <xsd:enumeration value="Proteomics"/> <xsd:enumeration value="Semiconductor"/> <xsd:enumeration value="Specialty Chemical"/> </xsd:restriction> </xsd:simpleType> </xsd:element> </xsd:sequence> </xsd:extension> </xsd:complexContent> </xsd:complexType> </xsd:element> <xsd:element name="Industry" ma:index="29" nillable="true" ma:displayName="Industry" ma:hidden="true" ma:internalName="Industry"> <xsd:complexType> <xsd:complexContent> <xsd:extension base="dms:MultiChoice"> <xsd:sequence> <xsd:element name="Value" maxOccurs="unbounded" minOccurs="0" nillable="true"> <xsd:simpleType> <xsd:restriction base="dms:Choice"> <xsd:enumeration value="Air"/> <xsd:enumeration value="Analysis of Process Chemicals"/> <xsd:enumeration value="Antibacterial Drug Residues"/> <xsd:enumeration value="Bioanalysis"/> <xsd:enumeration value="Biological Warfare Agents (BWA)"/> <xsd:enumeration value="Chemical Warfare Agents (CWA)"/> <xsd:enumeration value="Components Analysis"/> <xsd:enumeration value="Contamination Control"/> <xsd:enumeration value="Environmental Monitoring"/> <xsd:enumeration value="Flavors"/> <xsd:enumeration value="Food"/> <xsd:enumeration value="Fragrances"/> <xsd:enumeration value="Natural Compounds &amp; 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The application is responsible for updating this value after each revision. </xsd:documentation> </xsd:annotation> </xsd:element> <xsd:element name="lastModifiedBy" minOccurs="0" maxOccurs="1" type="xsd:string"/> <xsd:element ref="dcterms:modified" minOccurs="0" maxOccurs="1"/> <xsd:element name="lastPrinted" minOccurs="0" maxOccurs="1" type="xsd:dateTime"/> <xsd:element name="contentStatus" minOccurs="0" maxOccurs="1" type="xsd:string"/> </xsd:all> </xsd:complexType> </xsd:schema> </ct:contentTypeSchema>