FDA/Centers: your center training contact, who will submit it to the DHRD training officer.

Transcription

1 DATE: September 9, 2011 FROM: John Shafer Director, Division of Human Resource Development (HFC-60) SUBJECT: COURSE ANNOUNCEMENT Biomanufacturing Principles and Processes Training (DG426, DG427, DG428, DG429) North Carolina State University and On-line November, 2011 August, 2012 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, pre-requisite waivers, special requests for additional overnight stay) 5. Michael Chasey, Training Officer (final POC if the RTO is unavailable): FDA/Division of Human Resource Development Fax DEADLINES / SPECIAL NOTICES: Regional Training Officers, IA/International, Center Training Contacts: 1. Please provide a copy of this announcement to each participant as soon as they are identified. 2. By COB Friday, October 14, 2011, forward all participant names and registration information via to Michael Chasey. Course Participants: 1. Hotel Reservations - Lodging will be provided at a local area hotel. Participants will be notified at a later date with specific hotel information and reservation instructions. In addition, travel expenses and M&IE amounts will be provided to course participants. 2. By COB October 14, 2011, complete the Attachment A for Participant Registration Information at the end of the document and forward it via , as a Word attachment (Word Doc) to: FDA: your Regional Training Officer (RTO). FDA/Centers: your center training contact, who will submit it to the DHRD training officer. COURSE DESCRIPTION / OBJECTIVES: Biomanufacturing Principles and Processes Training (DG426, DG427, DG428, DG429) - This advanced series of courses is designed to provide training on topics relevant to the evaluation and inspection of biomanufactured pharmaceutical products. The courses will consist of web based interactive training modules, interactive online discussions, classroom lectures, and laboratory exercises, and pilot plant hands-on practicum. Objectives: Upon completion, participants will be able to: 1. Recognize key topics associated with bioprocessing, including biomolecules, cell culture, microbial fermentation, recovery and purification, process validation, process controls, and batch records. 2. Identify critical variables that can impact product quality. 3. Differentiate between key biological concepts supporting different biological production platforms, including bacterial and vertebrate cell structures. 4. Evaluate key differences in production platforms, key metabolic pathways, and media constituents, including cell growth kinetics. 5. Assess cell line authenticity and purity within the context of biological safety levels. 6. Identify critical control parameters required to ensure reproducible growth and product expression in a commercial bioreactor. 7. Recognize unit operations commonly used to recover and purify a target protein from a fermentation or cell culture broth, including homogenizations, centrifugation, chromatography, and ultrafiltration/diafiltration. 1

2 8. Evaluate in-process and finished product testing methods and instrumentation unique to biomanufacturing products. 9. Recognize equipment and facility operations unique to biomanufacturing, including upstream processing, downstream operations, environmental controls, cleaning, prevention of cross contamination, equipment, IQ, OQ, and PQ. 10. Evaluate common avenues of contamination of biomanufactured products. Assess container closure systems, cleaning, depyrogenation, sterilization, and environmental monitoring. 11. Identify critical process parameters. 12. Describe how critical process parameters interrelate in affecting process performance and final product quality. Target Audience: Experienced Consumer Safety Officers who are currently conducting sterile drug and/or biotech inspections (domestic and international). CSO s who are Level III drug program area candidates/certified will receive special consideration for this course. In addition, preference for selection into the training will be given to those Investigators who are 6-system audit certified at Level II and to those that attended DG306 - Biological Therapeutic Manufacturing (formally known as Therapeutics Biotech Update). CEU: For each course, NC State will award Continuing Education Units (CEUs) in accordance with criteria established by the International Association for Continuing Education and Training. These CEUs are recognized by DHRD and can be applied for Drug Investigator Certification maintenance. PREREQUISITES: 1. Selections will be made by DHRD based on information submitted in the participant registration form (see Attachment A). Participants, RTOs, and Center Training Contacts will be notified of the selections. See target audience for information on selection criteria. 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. Be on time and attend the entire course 2. Participate in class discussions, exercises, workshops, and presentations 3. Pass the course assessment(s) Course Assessments/Exam Policy All DHRD/ORA U sponsored courses are required to have course assessments. These assessments will be used to evaluate the effectiveness of the training presented and to asses how well the students grasped the material covered. Each course participant will be evaluated individually for each assignment/activity/exercise/workshop he/she participates in both online and onsite. SLOT ALLOCATIONS: There will be no specific slot allocations designated to each region. Instead, participant information will be reviewed by the Division of Human Resource Development/ORA U and students will be selected based on that review. Priority is given to those individuals who are: 1. Currently Level III Drug Investigator Certified (Pharmaceutical Inspectorate) 2. Currently Level II Drug Investigator Certified (6-system) 3. Completed DG306 - Biological Therapeutic Manufacturing (formally known as Therapeutics Biotech Update) COURSE DATES: Course DG426 - Upstream Bioprocessing Web-based modules availability November 14 December 9, 2011 Onsite NC State University December 12-14,

3 DG428 Quality Control/Analytical DG427 - Downstream Bioprocessing January 23 February 17, 2012 February 21-23, 2012 April 9 May 4, 2012 May 8-10, 2012 DG429 Aseptic Processing July 16 August 10, 2012 August 14-16, 2012 AUTHORIZED TRAVEL DATES (On-site modules at NC State only): Authorized arrival date: Monday prior to the Tuesday starting date Authorized departure date: Thursday evening after 8 pm, following the Thursday session which ends at 5pm, or Friday. Please note: Early departure from the classroom, laboratory, or hands-on practicum sessions of each course will not be permitted. If you wish to depart on Thursday, your travel arrangements must allow you to be in attendance at the BTEC site until 5:00 PM. TRANSPORTATION (On-site modules at NC State only): Raleigh, NC is serviced by Raleigh-Durham International Airport. Participants will be notified at a later date with specific transportation options. LODGING INFORMATION (On-site modules at NC State only): Lodging will be provided at a local area hotel. Participants will be notified at a later date with specific hotel information and reservation instructions. In addition, travel expenses and M&IE amounts will be provided to course participants. COURSE PRESENTATION AND LOCATION: Each course in this series will feature web-based participation as well as onsite classroom, laboratory, and handson pilot plant practicum training. The web-based component of each course is divided into four modules, each of which will require approximately two hours of learner time-on-task. The first three online modules will be asynchronous; trainees may complete all activities on their own schedule, at their own pace, from any computer with an internet connection. At the end of each asynchronous module, trainees will complete a self-assessment. Successful completion provides access to the next module. The three asynchronous modules must be completed prior to the fourth online module, which will be synchronous. This synchronous session requires the simultaneous participation of all students at a specified date and time. (The date is to be determined; the time will be 1 p.m. EST.) Students can connect to this session from any computer with an internet connection. This synchronous session will include a review of the key concepts from the three preceding modules; allow for questions and answers and group discussion; and prepare students for the on-site portion of the course. In the week following the synchronous session, students will travel to Biomanufacturing Training and Education Center (BTEC) at North Carolina State University in Raleigh, NC, where they will participate in three days (24 hours of instructional time) of classroom and hands-on training in BTEC s laboratories. The onsite classroom, laboratory, and hands-on pilot plant practicum training will be held Tuesday, Wednesday and Thursday from 8 am until 5 pm each day. Travel will be on Monday and Friday of the same week. Additional information about BTEC/NCSU can be found at and 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. 3

4 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. Weather conditions are unpredictable; please check the local weather in Raleigh, NC before packing. Temperatures can vary in conference rooms, therefore, dress in layers or bring a sweater/jacket. Students do not need to bring reference materials. All necessary materials will be provided. Bring your FDA credentials for security purposes when traveling. Request & justification to stay an additional night (if applicable): Requests need to be submitted to your Regional Training Officer (RTO) in advance via 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 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. For course attendees receiving training, the Operation Code is 84, and the PAC would be 56R800. For FDA course instructors, the Operation Code is 83; the PAC would be the same. 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 address: interpreting.services@oc.fda.gov. /s/ John Shafer Director, DHRD 4

5 Attachment for Participant Registration Information Attachment A Please submit the information as listed in the format and order below as a Word attachment (Word Doc) no later than COB October 14, 2011 via to: FDA: your Regional Training Officer (RTO). FDA/Centers: your center training contact, who will submit it to the DHRD training officer. Biomanufacturing Principles and Processes Training (DG426, DG427, DG428, DG429) North Carolina State University and On-line November, 2011 August, 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: 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. Are you Level III Drug Investigator certified? 2. If you are not Level III Drug Investigator certified, are you Level II Drug Investigator? 3. If you are not Level II Drug Investigator certified, have you submitted your Level II Drug Investigator certification package? 4. Have you conducted a sterile drug inspection? If so, how many? 5. Have you conducted a biotech inspection? If so, how many? 6. Have you successfully completed DG306 - Biological Therapeutic Manufacturing (formally known as Therapeutics Biotech Update)? 7. Are you able to attend all four sessions of this series? 5