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U.S. Department of Health and Human Services

Training and Continuing Education

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ORAU Course Catalog 2013 - DRUGS

 

Course ID:          DG230
Course Title:      Systems-Based Drug Inspections
 

Face-to-Face classroom instruction. Combines topics in the old DG201-Basic Drug School and DG307-Process Validation to introduce new investigators to the Systems-based approach to drug GMP inspections.

 

Course Description: The Drug Investigator Training Program is designed to provide new drug investigators with a combination of foundational knowledge and practical experience in drug cGMP inspections.  Participants complete a number of requirements that include web modules, face-to-face instruction, and participation in pharmaceutical inspections.
 
Objectives: Upon completion, participants will be able to:
 
  1. Outline regulatory requirements, guidance and procedures associated with systems-based drug GMP inspections.
  2. Discuss how to conduct a Quality System inspection
  3. Discuss how to conduct a Facilities and Equipment System inspection
  4. Discuss how to conduct a Materials System inspection
  5. Discuss how to conduct a Production System inspection
  6. Discuss how to conduct a Packaging and Labeling inspection
  7. Discuss how to conduct a Laboratory Controls System inspection
  8. Discuss regulations, resources, and approaches associated with systems-based inspections, including automated systems, electronic data, and risk managemen
  9. Explain how to prepare for an API inspection
  10. Discuss regulatory expectations specific to API production and how they differ from finished dosage production
  11. Describe common API production processes and equipment and how they may differ from finished dosage production
  12. Outline an API inspectional approach
  13. Identify possible deficiencies and other concerns associated with API production
  14. Identify the critical elements of the pre-approval inspection process
  15. Recognize the roles and responsibilities of field personnel and centers in the pre-approval inspection process
  16. Recognize the significance of inspectional findings and how they relate to field recommendations of withhold or approve
  17. Outline the principles of industrial sterilization, lyophilization, aseptic processes, removal of bacterial endotoxins, and supporting utilities
  18. Identify equipment and applications of industrial sterilization processes, methods and validation
  19. Apply the scientific principles of the processes of industrial sterilization, lyophilization, aseptic processes, removal of bacterial endotoxins, and the supporting utilities to an inspectional approach.
 
Target Audience: This program is designed for FDA personnel who conduct or are planning to conduct pharmaceutical manufacturing inspections.
 
Prerequisites: Participants must have successfully completed the ORA New Hire training curriculum including the audit (FDA Level I) prior to attending this program.
 
Course duration: Each course in the ORA DHRD Drug Investigator Training Program (DG230-Systems-Based Drug Inspections and DG330-Active Pharmaceutical,
Pre-Approval, and Sterile Drug Inspections) consists of a series of web modules, one field experience, and a two-week classroom session.
 
Duration of each requirement is as follows:
· DG230- Systems-Based Drug Inspections
     -  Asynchronous web-based modules: approximately 23 hours
     -  Field experience – varies by inspection
     -  Face-to-Face session – Two weeks
 
· DG330-Active Pharmaceutical, Pre-Approval, and Sterile Drug Inspections
     -  Asynchronous web-based modules: approximately 9 hours
     -  Field experience – varies by inspection
     -  Face-to-Face session – Two weeks
 
 
CEU: TBD
Course ID:            DG306
Course Title:        Biological Therapeutics Manufacturing
 
Course Description: The Biological Therapeutics Manufacturing is a 5 day advanced course designed to provide training on topics relevant to the evaluation and inspection of Therapeutic and Biotech Products. The course will describe the fermentation, purification, formulation, fill and finish processes used to manufacture biological therapeutic drugs as well as inspectional tips and techniques for these processes. The course will consist of lectures, case study presentations, and workshops.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Demonstrate a comprehension of the regulations that apply to the manufacture of biological therapeutic drugs
  2. Describe the fermentation, purification, formulation, fill and finish processes used to manufacture biological therapeutic drugs
  3. Identify potential areas of concern associated with the manufacture of biological therapeutic drugs
  4. Identify quality control procedures used to support the manufacture of biological therapeutic drugs
 
Target Audience: This is an advanced drug course intended for investigators, analysts, supervisors, and compliance officers who have successfully completed Basic Drug School (DG201) and conduct or are planning to conduct biological therapeutic manufacturing inspections.
 
Pre-Requisites:
  1. Have completed the ORA New Hire training curriculum, including audit (FDA: Level I). State employees should have completed their new hire program and have experience working in the program area
  2. Successfully completed Basic Drug School (DG201) training course
  3. Conducted or plan to conduct biological therapeutic manufacturing inspections
 
Course Duration: 5 Days
CEU: 3.8
 
 
Course ID:           DG330
Course Title:       Active Pharmaceutical, Pre-Approval and Sterile 
                                Drug Inspections
 
Face-to-Face classroom instruction. Combines and streamlines topics from the old DG303-Active Pharmaceutical Ingredient Inspections, DG301-Pre-Approval Inspections, and MP302-Industrial Sterilization.
 
Course Description: The Drug Investigator Training Program is designed to provide new drug investigators with a combination of foundational knowledge and practical experience in drug cGMP inspections.  Participants complete a number of requirements that include web modules, face-to-face instruction, and participation in pharmaceutical inspections.
 
Objectives: Upon completion, participants will be able to:
 
  1. Outline regulatory requirements, guidance and procedures associated with systems-based drug GMP inspections.
  2. Discuss how to conduct a Quality System inspection
  3. Discuss how to conduct a Facilities and Equipment System inspection
  4. Discuss how to conduct a Materials System inspection
  5. Discuss how to conduct a Production System inspection
  6. Discuss how to conduct a Packaging and Labeling inspection
  7. Discuss how to conduct a Laboratory Controls System inspection
  8. Discuss regulations, resources, and approaches associated with systems-based inspections, including automated systems, electronic data, and risk managemen
  9. Explain how to prepare for an API inspection
  10. Discuss regulatory expectations specific to API production and how they differ from finished dosage production
  11. Describe common API production processes and equipment and how they may differ from finished dosage production
  12. Outline an API inspectional approach
  13. Identify possible deficiencies and other concerns associated with API production
  14. Identify the critical elements of the pre-approval inspection process
  15. Recognize the roles and responsibilities of field personnel and centers in the pre-approval inspection process
  16. Recognize the significance of inspectional findings and how they relate to field recommendations of withhold or approve
  17. Outline the principles of industrial sterilization, lyophilization, aseptic processes, removal of bacterial endotoxins, and supporting utilities
  18. Identify equipment and applications of industrial sterilization processes, methods and validation
  19. Apply the scientific principles of the processes of industrial sterilization, lyophilization, aseptic processes, removal of bacterial endotoxins, and the supporting utilities to an inspectional approach.
 
Target Audience: This program is designed for FDA personnel who conduct or are planning to conduct pharmaceutical manufacturing inspections.
 
Prerequisites: Participants must have successfully completed the ORA New Hire training curriculum including the audit (FDA Level I) prior to attending this program.
 
Course duration: Each course in the ORA DHRD Drug Investigator Training Program (DG230-Systems-Based Drug Inspections and DG330-Active Pharmaceutical,
Pre-Approval, and Sterile Drug Inspections) consists of a series of web modules, one field experience, and a two-week classroom session.
 
Duration of each requirement is as follows:
· DG230- Systems-Based Drug Inspections
     -  Asynchronous web-based modules: approximately 23 hours
     -  Field experience – varies by inspection
     -  Face-to-Face session – Two weeks
 
· DG330-Active Pharmaceutical, Pre-Approval, and Sterile Drug Inspections
     -  Asynchronous web-based modules: approximately 9 hours
     -  Field experience – varies by inspection
     -  Face-to-Face session – Two weeks
 
 CEU:  TBD
Course ID:            DG402
Course Title:        Process Analytical Technology (PAT)
 
Course Description: This training program is designed to further develop the skills of Agency staff and supplement the existing knowledge of participants by providing an in-depth knowledge of process analytical technology (PAT) and the associated regulatory framework, including the team approach to regulation. Instructors include experts from academia and industry, as well the FDA. The objective of this program is to further develop a team that possesses the knowledge and skills necessary to evaluate and assess the application of the PAT framework.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Assess and evaluate the application of PAT
  2. Demonstrate an in-depth understanding of PAT, including the guidance and regulatory process
  3. Demonstrate the application of the PAT framework to diverse processes
  4. Demonstrate unity in diversity by recognizing and appreciating the value of multidisciplinary teams
 
Target Audience: Participants in this training program will include representatives from the Office of Regulatory Affairs (ORA) and the Center Drug Evaluation and Research (CDER). Selection of participants will be based on the needs and resources of each Center/Office.
 
Prerequisites: There are no specific pre-requisites for this course, as the class participants will be screened by the appropriate ORA and CDER representatives before acceptance into this training class.
 
Post-Course Assessment: None
NOTE: *Duquesne University will award Continuing Education Units (CEUs) in accordance with criteria established by the Accreditation Council for Pharmacy Education (ACPE). For those participants that are not pharmacists, a certificate of completion will be provided.
 
Course Duration: 4.5 Days
CEU: See Note*
 
Course ID:            DG403
Course Title:        Positron Emission Tomography (PET)
 
Course Description: This is an on-line course available for review under ORA U on-line courses. This training assists FDA Investigators to gain familiarity with and apply the new Positron Emission Tomography (PET) regulations 21 CFR 212, and the new CPGM to strategies when conducting PET manufacturing facility inspections. The focus of this training is on PET production processes and system controls, including lab controls and aseptic controls.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Identify key PET drug production processes.
  2. Identify PET drug material and production system controls.
  3. Demonstrate by discussion, comprehension of regulations and guidance that apply to PET drug inspections
 
Target Audience: The primary target audience is the Level II and Level III ORA investigator with experience performing drug and sterile drug inspections.   Some will have conducted PET inspections under 21 CFR 211.
 
Pre-requisites:
  1. Radiation safety course
  2. Level II and Level III Investigator certification
  3. Experience performing drug /sterile drug inspections
 
Course Duration: 2.83 Hours
CEU: 0.3
 
Course ID:            DG408
Course Title:        Level III Drug Investigator Certification Training Program
 
Course Description: Level III Drug Investigator Certification Training Program is designed to further develop the skills of Investigators who conduct complex drug inspections on a routine basis. Topics include risk assessment, pharmaceutical quality, Quality by Design (QbD), Design of Experiments (DOE), and discussions of transdermal, positron emission tomography (PET), and metered dose inhaler drug products. Instructors include FDA regulatory and inspectional experts as well as industry experts in the pharmaceutical field.
 
Course Objectives:
Upon completion of this course, the participants will be able to:
  1. Explain the philosophy behind why we regulate pharmaceutical quality and how pharmaceutical quality relates to FDA’s mission.
  2. Apply risk assessment and prioritize the risks associated with drug products as they relate to quality.
  3. Assess quality systems approaches to aspects of pharmaceutical production and quality assurance.
  4. Describe the science underlying the approaches to both controlling product quality and causes of variability.
  5. Describe the integration of the review program and inspectional program as they relate to each other regarding product quality.
  6. Identify the science and technology advances used in pharmaceutical manufacturing processes.
 
Target Audience: This course is a prerequisite for those individuals who will be seeking Level III Drug Investigator Certification, leading to membership in the Pharmaceutical Inspectorate.
The Level III Drug Investigator Certification training course is designed primarily for an audience interested in attaining Level III Drug Investigator certification. Preference for selection into the training should be given to those Investigators who are 6-system-audit certified at Level II. Preference for attendance to the Level III Drug Investigator training course will be given in the following order:
  1. Investigators who are Level II drug certified
  2. Investigators who have submitted a Level II drug investigator certification packet
  3. Investigators who have completed some of the following drug training courses:
 a.  Systems-Based Drug Inspections (DG230)
 b.  Active Pharmaceutical, Pre-Approval and Sterile Drug Inspections (DG330)
 
Prerequisites: See information supplied in “Target Audience”
 
Course Duration: 5 Days
CEU: 3.8
 
Biomanufacturing Principles and Process Training
Course ID and Title: DG426 Upstream Bioprocessing
Course ID and Title: DG427 Downstream Bioprocessing
Course ID and Title: DG428 Quality Control/Analytical
Course ID and Title: DG429 Aseptic Processing
 
Course Description: 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.
 
Course Objectives:
Upon completion of this course, the participant 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.
  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, and 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) and who is at least Level II certified in the drug program area. CSO’s who are Level III drug program area candidates/certified will receive special consideration for this course. In addition, previous attendance at the Therapeutics Biotech Update (DG306) is preferred.
 
Pre-Requisites:
  1. Must be experienced CSOs who are currently conducting sterile pharmaceutical facility inspections.
  2. Must have successfully completed Level II Drug Certification or submitted final paperwork for processing.
  3. Course participants will be expected to continue to conduct sterile pharmaceutical cGMP, Therapeutics, Biotechnology, and biomanufacturing facility inspections upon completion of the course series.
 
Course Duration: Each course in this series will feature web-based participation as well as onsite classroom, laboratory, and hands-on pilot plant practicum training. The web-based component of each course is divided into four modules, each of which will require approximately two (2) 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 (3) 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 (3) 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.
 
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.