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U.S. Department of Health and Human Services

Training and Continuing Education

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ORAU Course Catalog 2013 - BIOLOGICS

 
Course ID:            BI201
Course Title:        Blood Banking and Plasmapharesis I
 
Course Description: This 4½ day course is designed to provide an overview of the blood banking and source plasma program area. It will provide practical training on the methods and techniques used in conducting blood bank, source plasma, and donor testing facility inspections. The course will consist of pre-course reading assignments, lectures, in-class exercises, and a final exam.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Identify the appropriate compliance programs, policies, guidance, regulations, and acts to conduct risk-based inspections (i.e., critical control points) of blood establishments.
  2. Identify the basic operations of blood establishments (blood banks, plasma centers, and testing facilities) and interpret the associated terminology.
  3. Apply the applicable regulations and know the available resources to conduct inspections of blood establishment operations (blood banks, plasma centers, and testing facilities).
  4. Write an accurate FDA-483 using Turbo EIR based on supporting documents collected and evidence observed during an inspection to support a potential enforcement action.
 
Target Audience: This course is designed for Consumer Safety Officers, Compliance Officers and Supervisory Consumer Safety Officers who will be conducting, participating or reviewing inspections involving blood banks, source plasma centers and donor testing laboratories.
 
Prerequisites:  Prior to attending, nominees must:
  1. Complete the ORA New Hire training curriculum (FDA:  Level I including the audit), or completed the six (6) month district training program (includes 3 week ORA New Hire training curriculum), if hired prior to January 1, 2002 and not Level I; State employees must have completed their new hire program and have experience working in the program area.
  2. An active TURBO EIR account and have written a 483 in TURBO.
  3. Read all pre-course reading materials. (will be provided to enrolled participants prior to course)
  4. Completed the pre-course terminology challenge and emailed it to the course Training Officer. (will be provided to enrolled participants prior to course)
 
Course Duration: 4.5 Days
CEU: 3.3
 
Course ID:            BI205
Course Title:        Core Team Biologics
 
Course Description: This course is designed to provide training on licensed biological products, their unique nature, their manufacturing processes and the applicable regulations for these products. The course will consist of lectures, and case studies. It will also include lively discussions on cutting edge technologies.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Identify basic scientific principles of licensed biological products
  2. Identify the unique nature of biological products
  3. Identify the unique manufacturing aspects of biological products
  4. Identify the applicable regulations for biological drugs and devices
 
Target Audience:  ORA Investigators and Compliance Officers that are members of Team Biologics and CBER Compliance Officers and Product Specialists that are involved in the review and inspection process of biological products.
 
Prerequisites: Prior to attending, nominees must:
  1. Be a current member of Team Biologics who has not taken this course.
  2. Be actively involved in the inspection, compliance review or technical/scientific review of plasma fractionators, vaccine, biotech, allergenic and/or biological IVD products.
 
Course Duration: 5 Days
CEU: 3.6
 
Course ID:            BI206
Course Title:        Inspections of Human Cells, Tissues & Cellular and Tissue Based 
                               Product
(HCT/P) Establishments 
 
Course Description: This 4½ day course is designed to train Investigators, Compliance Officers, Supervisory Investigators and Microbiologists on the regulatory authority, manufacturing operations, inspectional approaches and terminology that are essential when conducting inspections of Human Cells, Tissues & Cellular and Tissue Based Product (HCT/P) establishments that are covered under 21 CFR 1270 and 1271. The course will consist of pre-course assignments, lectures, exercises, and post course challenge.
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Identify the appropriate compliance programs, policies and regulations to conduct efficient inspections of human cells, tissues & cellular and tissue based product establishments.
  2. Identify the basic operations and interpret the terminology used in human cells, tissues & cellular and tissue based product establishments.
  3. Relate current human cells, tissues & cellular and tissue based product establishment inspection procedures to their inspections through exercises.
  4. Construct an accurate and meaningful FDA 483.
 
Target Audience: Consumer Safety Officers, Supervisory Consumer Safety Officers, Compliance Officers and Microbiologists who will be conducting, participating in and or reviewing inspections of Human Cells, Tissues & Cellular and Tissue-Based Product Establishments.
 
Prerequisites: Prior to attending, nominees must:
  1. Participate in at least one HCT/P establishment inspection.
  2. Read and be familiar with the contents of the regulations and Compliance Programs and completed the pre-course assignment (see “Completion Requirements/Course Assessment Requirements” section of this announcement).
  3. Complete the ORA New Hire training curriculum course.
 
Course Duration: 4.5 Days
CEU: 3.3
 
Course ID:            BI301
Course Title:        Blood Banking and Plasmapharesis II
 
Course Description: This 3½ day course is the second part of the basic blood bank course. The course will consist of lectures, case studies and a photo tour of blood establishments, and will provide an overview of the various blood products, processes, and applicable regulations. This course will cover case development, contract manufacturing, new blood establishment issues and procedures, special source plasma programs, and Nucleic Acid Testing (NAT) principles. In addition, view an apheresis collection procedure used in blood and plasma establishments. Course participants will also analyze blood and plasma establishment FDA 483s and cases.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Apply the appropriate compliance programs, policies and regulations to the most complex blood establishment inspections.
  2. Construct an accurate and meaningful FDA 483 using Turbo EIR.
  3. Assess and classify establishment reports associated with blood establishments for regulatory action.
  4. Identify more complex operations and new issues in blood and plasma establishments.
 
Target Audience: This course is designed for Consumer Safety Officers, Supervisory Consumer Safety Officers and Compliance Officers who will be conducting, participating in and/or reviewing inspections and reports involving blood banks, source plasma centers and donor testing laboratories.
 
Prerequisites: Prior to attending, nominees must:
  1. Have completed the ORA New Hire training curriculum (FDA: Level I, including the audit), or completed a six (6) month district training program (includes 3 week ORA New Hire training curriculum) if hired prior to January 1, 2002 and not Level I; State employees must have completed their new hire program and have experience working in the program area.
  2. Have an active TURBO EIR account and have written a 483 in TURBO
  3. Successfully complete the Blood Banking & Plasmapheresis I (BI201) training course.
  4. Participate and/or review at least one (1) blood banking or plasma inspection within one (1) year of attending the course.
  5. Complete the pre-course reading.
 
Course Duration: 3.5 Days
CEU: 2.6
 
Course ID:            BI305
Course Title:        Team Biologics Update
 
Course Description: This course is designed to update the participants’ technical training and to encourage team building between Team Biologics members & CBER Product Specialists that will be involved in team inspections together. The course will consist of lectures, case studies and a team building exercise.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Identify advanced technical issues relative to inspections of licensed Biologics products.
  2. Develop more effective communication among team members to enhance the regulatory outcome of inspections.
  3. Expand evidence identification and collection skills to support inspection observations that lead to compliance action.
 
Target Audience: ORA Investigators and Compliance Officers that are members of Team Biologics and CBER compliance officers and product specialists that are involved in the review and inspection process of biological products.
 
Prerequisites: Prior to attending, nominees must:
  1. A current member of Team Biologics or CBER Product Specialist or Application Reviewer that will be involved in ORA Team inspections with members of Team Biologics.
  2. Actively involved in the inspection, compliance review or technical/scientific review of plasma fractionators, vaccine, biotech, allergenic and/or biological IVD products.
 
Course Duration: 4.5 Days
CEU: 3.2
 
Course ID:          BI306
Course Title:     Tissue Update: Inspection of Human Cells, Tissues & Cellular and Tissue Based 
                             Products (HCT/Ps) Inspectional Update
 
Course Description:  This 4 day webinar is designed to provide FDA Investigators with updated information for conducting or reviewing inspections of Human Cells, Tissues & Cellular and Tissue Based Product (HCT/P) establishments covered under 21 CFR 1270 and 1271 and parts 351 and 361 of the PHS Act with broadened explanations and clarification of the regulatory authority for tissues and tissue products, validation processes, and policy and procedures. The online course consists of 4 separate webinar sessions ranging from three hours to three hours and thirty minutes and a final assessment that must be completed independently after the webinar in order to receive credit for successful completion of the webinar.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Identify which laws/regulations apply to tissue products
  2. Identify the specific areas to cover based on the type of tissue and tissue use
  3. Identify the available processing methods
  4. Identify what activities require validation or verification
  5. Identify the key components in evaluating the adequacy of a firm’s validation
 
Target Audience:  This webinar is designed for all Consumer Safety Officers, Supervisory Consumer Safety Officers, Microbiologists and Compliance Officers who have previously taken BI206 and will be responsible for participating in or reviewing inspections of Human Cells, Tissues & Cellular and Tissue-Based Product Establishments.
 
Note: This course is available on ORA U under on line courses.
 
 
CEU: 1.2

Course ID:            BI308
Course Title:        ARC Amended Consent Decree Training for Inspection CADRE
 
Course Description: The course is designed to provide senior investigators with updated information on the April 15, 2003 Amended Consent Decree. This group of investigators will be responsible for conducting comprehensive inspections of ARC regional centers, National Testing Laboratories (NTLs) and Donor Client Support Centers (DSCSs). This interactive course will consist of lectures, interactive exercises and a case study.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Apply provisions of the amended consent decree to violative conditions observed during an ARC inspection.
  2. Develop adequate evidence to support FDA 483 observations and assessment of monetary penalties or other enforcement actions.
  3. Effectively demonstrate the procedures for communicating with the Consent Decree Working Committee regarding the inspection.
  4. Provide skills for training/mentoring other district investigators who will be conducting inspections of ARC facilities under the amended Consent Decree.
 
Target Audience: Seasoned ORA field investigators with experience conducting ARC regional and National Testing Laboratories (NTLs) inspections only.
 
Prerequisites: Prior to attending, nominees must:
  1. Be a seasoned ORA field investigators with experience conducting ARC regional and NTL inspections only.
  2. Be stationed in a district office or resident post where there is a national ARC facility, specifically a regional facility, NTL and/or DCSC.
  3. Be a GS-13 Biologics Specialist with Level II certification or qualified to apply for Level II Certification or a regional Biologics Specialist position.
  4. Be Level I certified.
 
Participants that attend this course will be members of an Inspectional Cadre that will focus on inspections of ARC regions, NTLs and DCSCs. These investigators will also be expected to train/mentor and guide other district personnel that conduct inspections of ARC facilities in the future.
 
This course is not for Supervisors or Compliance Officers.
 
Course Duration: 3 Days
CEU: Pending
 
Course ID:            BI420
Course Title:        Blood Bank Investigator Certification Program - Performance Auditor
 
Course Description: The
Level 2 Blood Bank and Plasma Center Investigator Certification Program audits the performance of investigator certification candidates against an established set of performance audit criteria. The audit is conducted by Performance Auditors who successfully complete the required training. Participants who successfully complete this training will be authorized to conduct Performance Audits for the Level 2 Blood Bank and Plasma Center Investigator Certification Program. During the training, participants will be given an overview of the Level 2 Blood Bank and Plasma Center Investigator Certification Program and introduced to the policies, procedures, and forms used during the performance audit as well as the roles and responsibilities of a Level 2 Investigator Certification Program Blood Bank and Plasma Center Performance Auditor. The course is delivered by lectures, case studies, and exercises that cover the requirements of the program and techniques of investigator auditing. Participants who successfully complete the program will be identified as Level 2 Blood Bank and Plasma Center Investigator Certification Program Performance Auditors.
 
Course Objectives:
To
successfully complete this event, participants will be expected to be able to:
 
  1. Prepare for an audit and become familiar with Level 2 Blood Bank Investigator Certification Auditor Training Program policies prior to conducting an audit
  2. Apply knowledge consistent with Level 2 Blood Bank Investigator Certification Auditor Training Program policies and procedures when conducting an audit
  3. Demonstrate how to document the results of the audit and follow audit closure procedures consistent with Level 2 Blood Bank Investigator Certification Auditor Training Program policies and procedures
 
Target Audience:  
Active Level 2 Blood Bank and Plasma Investigator Certification Program Performance Auditors and qualified investigators who meet established prerequisites
 
Prerequisites:
1.       Management concurrence to participate in this course                               
2.       To qualify as an auditor for the Level 2 Blood Bank and Plasma Center Investigator Certification Program, potential auditors must:
 i.            Be certified as a Level 2 Blood Bank and Plasma Center Investigator for at least one maintenance period (3 years)
 ii.            Have District Management, including direct supervisor and DIB or DD, concurrence to participate as an auditor in the program and confirmation that the candidate displays the following traits:
 
a)      Be willing to accept assignments which require an ability to adapt to changing tasks, responsibilities and environments, while meeting expected deadlines.
 
b)      Be able to think logically and creatively without undue influence from personal bias.
 
c)       Possess a high level of technical competence regarding agency policies and regulations
 

d)      Have demonstrated a history of being able to find and document violative conditions that would support blood bank and plasma center regulatory actions according to agency policy and regulations versus using their own criteria and interpretations.

 
e)      Be able to work with others in a cooperative, goal-oriented manner while recognizing the individual qualities of people.
 
f)       Be able to remain impartial toward any reputation that a candidate may have, and judge the candidate’s competency on facts revealed during the performance audit.
 
g)      Possess good communication skills which include the ability to communicate opinions, observations, and conclusions in a courteous and respectful manner.
 

iii. Successfully complete a screening by the Level 2 Blood Bank and Plasma Center Investigator Certification Board. The Certification Board has the discretion to require additional training and experience for candidates to be identified as a performance auditor. 

 
 
Course Duration: 15.25 Hours
CEU: 1.5 (Pending Approval)