FROM: John Shafer Director, Division of Human Resource Development (HFC-60)



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DATE: December 2 nd, 2011 FROM: John Shafer Director, Division of Human Resource Development (HFC-60) SUBJECT: COURSE ANNOUNCEMENT: ORAU 11919 Rockville Pike Rockville, MD 20852 Begin: Monday, March 5th at 8:00 AM End: Friday, March 9th at 12:00 PM AUTHORIZED TRAVEL DATES: Arrival: Sunday, March 4th Departure: Friday, March 9th (schedule return flights after 2PM) Everyone is expected to return on the departure date unless there are extenuating circumstances POINTS OF CONTACT: Participants seeking information or assistance with this training course should contact in the following order: 1) Immediate Supervisor (first source of information and assistance) 2) New Hire Training Coordinators (for new hire related questions) 3) District Administrative Officer (AO) (Gov Trip, travel, and accounting code information) 4) Regional Training Officer (RTO) (cancellation, substitutions, hotel issues, prerequisite waivers, special requests for additional overnight stay) 5) Douglas Ng, Training Officer (final POC if the RTO is unavailable) FDA/Division of Human Resource Development Office 301-796-8136 Blackberry 240-506-2868 Fax 301-827-8708 e-mail: Douglas.Ng@fda.hhs.gov COURSE DESCRIPTION / OBJECTIVES: The techniques and tools emphasized in this course will provide the FDA employee with the knowledge and skills to request firm electronic data and mine vast amounts of information. Objectives: Upon completion, participants will be able to apply Microsoft Excel, Adobe Acrobat and Microsoft Access functions to review and examine electronic data. 1. Participant will be able to discuss techniques used to obtain e-data and collect supporting evidence. 2. Participants will be able to apply Excel, Adobe & Access functions to review and examine electronic data (e-data) to identify trends. 3. Participant will be able to convert data from Access to Excel 4. Participant will be able to use translation tools to aid inspection activities Target Audience: The primary target audience for the training is the new and seasoned FDA CSO in any commodity area in which electronic records are used by firms. The new CSO must have some independent inspectional experience. CEU: 3.2 Continuing Education Units will be offered for this course PREREQUISITES: Prior to attending, nominees must: Attend New Hire Training (Basic Food and Drug Law/Evidence Development /Investigative Interviewing). Successful completion of Level 1 Investigator audit. Supervisory endorsement stating the employee has successfully completed Level I Certification. Familiarity with the basic features of Microsoft Excel or successful completion of the HHS University online module, Basic Features of Excel 2003 located at https://learning.hhs.gov/ course ID 113187 Familiarity with the basic features of Microsoft Access or successful completion of the HHS University

online module, Getting Started with Access 2003 located at https://learning.hhs.gov/ course ID 125937 ********* Familiarity with MS Excel and Access********* Any students who are not completely familiar and comfortable with the basic functionality of Microsoft Excel (including the use of basic formulas and pivot tables) and Access must complete the following Microsoft Office Online training courses prior to attending this course. These courses provide an excellent background of basic functionality that we utilize throughout the upcoming course. Consequently, it is critical that participants be given sufficient time to complete the specified courses. Individuals who have limited or no experience with Excel or Access may need 8-12 hours to take these courses. Excel Training > Excel 2003 > Audio course: Get to know Excel: Create your first workbook Training > Excel 2003 > Audio course: Get to know Excel: Enter formulas Training > Excel 2003 > Audio course: So that's how! Working with really big worksheets Training > Excel 2003 > All about AutoFilter Training > Excel 2003 > PivotTable I: What's so great about PivotTable reports? Training > Excel 2003 > PivotTable II: Swing into action with PivotTable reports Access Training > Access 2003 > Get to know Access It is extremely important that all nominees take these on-line courses, since we will expect them to have a basic understanding of the material which is covered in them when they arrive at the Computer Aided Inspection course. They should be considered as part of this training course that are taken in the employee s office. Each of the above course names provides a link to the course within this electronic document. Please note that you must hold down the Control key and left click the course name to link to a course. The above courses, along with additional online Excel and Access training courses, can also be found at the following link: http://office.microsoft.com/en-us/training/default.aspx. Select Access 2003 or Excel 2003 from Browse Training Courses area near the bottom of the web page. COURSE COMPLETION REQUIREMENTS: To successfully complete this course and receive a course certificate with Continuing Education Units* (CEUs), each participant will be required to: 1. Complete pre-course assignments 2. Be on time and attend the entire course 3. Participate in class discussions, exercises, workshops and presentations 4. Pass the course assessment(s) Course Assessments/Exam Policy* As an authorized provider of Continuing Education Units accredited through the International Association for Continuing Education and Training (IACET), DHRD courses are required to have an assessment(s) component (knowledge & application) to evaluate the effectiveness of the training presented and the participant s grasp of the material covered. Participants will receive only a pass/fail score. Minimum passing score is. SLOT ALLOCATIONS: RTOs will allocate slots to the Districts utilizing the ORA survey data: Region Slots NER 5 CER 9 SER 4 SWR 4 PAR 8 DEADLINES / SPECIAL NOTICES: Regional Training Officers, IA/International, Training Contacts: 1. Please provide a copy of this announcement to each participant as soon as they are identified

2. By COB 01/06/2012, forward all participant names and registration information via e-mail to Douglas Ng (Douglas.Ng@fda.hhs.gov) Course Participants: 1. Hotel Reservations by COB 02/03/2012, participants and instructors that will be in travel status must confirm their reservation at The Legacy Hotel & Meeting Centre 301-881- 2300, room block: FDA CAI Course (See LODGING INFORMATION below for additional information.) 2. By COB 01/12/2012, complete the Attachment A and forward it via e-mail, as a Word attachment (Word Doc) to: FDA: Your Regional Training Officer (RTO) TRANSPORTATION: Travelers must select an airport and flight that is most cost effective to the Government, in accordance with the Federal Travel Regulations. Reagan Washington National (DCA) Baltimore Washington International (BWI) Dulles International Airport (IAD) Rental cars are NOT authorized. DC Metro: http://www.wmata.com/rail/ Shuttles (need 24 hours notice): Maryland Service (301) 230-0000 http://www.marylandshuttle.com/ Blue Van (800) 258-3826 LODGING INFORMATION: The Legacy Hotel & Meeting Centre Lodging: $211 + tax M&IE: $71 1775 Rockville Pike Reservations By: 02/02/2012 Rockville, Maryland 20852 Check-in time:0300 PM Checkout: 12 Noon 301-881-2300 Room Block: FDA CAI Course Hotel Cancellation Policy: No later than 72 hours prior to your intended arrival date to avoid cancellation charges. If you cancel, please obtain a cancellation number from the hotel. COURSE LOCATION You will need your government ID to enter the building. Please allow enough time to get from the hotel to the building and through security prior to the start of class. ORA U, Room 116 301-796-4550 11919 Rockville Pike Rockville, MD 20852 Metro: From the Bethesda Metro station, across the street from the hotel, take the red line train toward Shady Grove. Get off at White Flint metro station and walk 2 city blocks north on Rockville Pike. Parking at ORA U: Local participants and instructors are strongly encouraged to ride Metro, carpool, or use public transit since parking at ORA U is limited. Those commuting locally need to voucher parking expenses with their office (local voucher) except for ORA staff. Instructors, CAG (Course Advisory Group) members, and those employees who car pool (two or more) to ORA U may be granted permission to park at ORA U on a case by case basis pending availability and providing arrangements are made two weeks in advance with the

DHRD course training officer. Please contact the training officer two weeks in advance to confirm arrangements and receive further instructions for parking. Possible parking options for local participants and instructors who must drive to ORA U; 1. White Flint Metro station and use the pay-to-park lot. Reference the following links for more information; http://www.wmata.com/default.cfm : http://www.wmata.com/riding/hours_fares.cfm#metrorail_fares 2. Metrorail daily parking is available at the parking lot east of Rockville Pike on Marinelli Road. ACCOUNTING AND ADMINISTRATIVE INFORMATION When a participant fails to confirm a hotel reservation by the deadline and cannot obtain lodging at the negotiated rate, any additional cost must be paid by the nominee s district, unless the district obtains prior approval from DHRD. Approval requests should be forwarded to the Training Officer for a case by case review by DHRD management. Employees should stay at the designated hotel with the negotiated room block. If the employee chooses to stay at a different hotel, the employee will be responsible for any costs incurred above and beyond what the expenses would have been if the employee stayed at the hotel with the negotiated room block. Reimbursement will be made at the negotiated rate. If the employee does not use the room block, the employee must use GovTrip to book the hotel. When accounting codes are released approximately 4 weeks prior to the course, the training officer will send a Travel Authorization Memo to ORA participants and FDA instructors. Rental cars are not authorized Civilian dress is business casual as defined by your district. Commissioned Corps Officers are required to be in uniform while attending training. Prior to attending the course, the commissioned officer should contact CAPT Diann Shaffer (ORA Commissioned Corps Liaison) if unsure which uniform to wear on a scheduled plant tour. Temperature may vary in the conference room - please bring layers of appropriate clothing. Bring your FDA or other official government issued identification for identity verification. Please note: Due to budget constraints, DHRD will no longer pay for UPS return shipment of student manuals, etc. Request & justification to stay an additional night (if applicable): Requests need to be submitted to your Regional Training Officer (RTO) in advance via email by the student s supervisor. One request can be provided for all students listed from the same District/Lab. Approval must be granted prior to the student traveling to the course and DHRD is unable to assist in reimbursement for after the fact. The RTO will forward requests to the DHRD Training Officer for review/approval. The request is to include: 1. Reason/justification for request to address factors such as: District policy indicating what is an unreasonable hour for travel (if citing undue hardship to the employee) Available flight times (contract and non-contract) Airports researched (if more than one in the area) Any related cost comparison (non-contract fare vs. staying the extra night) 2. Statement of supervisory concurrence If approved, your voucher needs to include a copy of the e-mail granting approval to stay the extra night. After the course, FDA participants should report their actual course time in

the Miscellaneous Operations Accomplishment Hours screen in FACTS following all applicable guidance. The data entered should include the appropriate Operation Code Op 84 and PAC 99R800 SPECIAL NEEDS: FDA provides reasonable accommodations to employees with disabilities. If you need a reasonable accommodation for any part of the training process - due to medical conditions, physical limitations or particular learning challenges - please notify the Training Officer prior to the course. Reasonable accommodations will be granted on a case-by-case basis. For Voice TTY or other interpreting needs, please contact Interpreting Services at the following e-mail address: interpreting.services@oc.fda.gov. /s/ John Shafer Director, DHRD Attachment A Attachment for Participant Registration Information Please submit the information as listed in the format and order below as a Word attachment (Word Doc) no later than COB 01/12/2012 via e-mail to: FDA/ORA: your Regional Training Officer (RTO). Rockville, MD 03/05/2012-03/09/2012 Participant Registration Information Participant s Legal Name: Position/Title: GS Series and Grade: Agency/Organization/Division: Duty Station (Complete Address with Mail Code): Business Phone Number and Extension: Fax Number: E-mail address: Supervisor s Name: Supervisor s Phone Number: Arrangements needed to accommodate special needs (if any): Name and Phone Number to contact in case of emergency (optional): Course Prerequisites; 1. Completion date of your new hire training curriculum FDA: Level I (including the audit) or 6 month district training program if hired prior to Jan 1, 2002 and not Level I State: Basic Food Inspection Training Curriculum in Standard 2, Manufactured Food Regulatory Program Standards 2 Familiarity with the basic features of Microsoft Excel or successful completion of the HHS University online module, Basic Features of Excel 2003. 3 Familiarity with the basic features of Microsoft Access or successful completion of the HHS University online module, Getting Started with Access 2003.