Biomanufacturing Fiscal Year Contact Hours

The current fiscal year will be included in the trend chart once it ends.

2024-2025

Course Lab+Lecture Hours Participants Contact Hours
Advanced Technical Writing 8 x 24 = 192
Aseptic Processing Concepts 12 x 105 = 1260
Aseptic Processing I 24 x 171 = 4104
Aseptic Processing II 24 x 23 = 552
Basic Technical Writing 6 x 71 = 426
CGMP Overview for Medical Devices 4 x 84 = 336
CGMP Overview for Pharmaceuticals 4 x 194 = 776
Deviations, Root Cause Analysis and CAPA Resolution 8 x 97 = 776
Disinfection, Sterilization, and Containment 6 x 23 = 138
Downstream Processing Lab Practical 16 x 47 = 752
Elements of Good Documentation Practices (GDP) and Data Integrity 4 x 68 = 272
FDA Audit Preparation 8 x 33 = 264
FDA Inspection Preparation 4 x 55 = 220
Good Documentation Practices (GDP) and Data Integrity 8 x 137 = 1096
HPLC in Theory and Practice 16 x 6 = 96
Micropipetting Techniques for Precision & Accuracy 8 x 28 = 224
Quality Risk Management 8 x 31 = 248
Upstream Processing - Mammalian Cell Culture 16 x 46 = 736
Writing Effective SOP's 4 x 74 = 296
Totals 1317 12764

Trend

View supporting data below.

2023-2024

Course Lab+Lecture Hours Participants Contact Hours
Aseptic Processing Concepts 12 88 1056
Aseptic Processing I 24 198 4752
Aseptic Processing II 24 29 696
Basic Microbiological Lab Skills 16 16 256
Basic Technical Writing 6 277 1662
CGMP Overview for Medical Devices 4 9 36
CGMP Overview for Pharmaceuticals 4 323 1292
Cleanroom Gowning Concepts 4 8 32
Deviations, Root Cause Analysis and CAPA Resolution 8 143 1144
Downstream Processing Lab Practical 16 96 1536
Elements of Good Documentation Practices (GDP) and Data Integrity 4 20 80
Environmental Monitoring Program for Aseptic Processing 16 16 256
FDA Audit Preparation 8 91 728
Good Documentation Practices (GDP) and Data Integrity 8 133 1064
Upstream Processing - Mammalian Cell Culture 16 52 832
Writing Effective SOP's 4 129 516
Totals 1628 15938

2022-2023

Course Lab+Lecture Hours Participants Contact Hours
Advanced Technical Writing 8 102 816
Aseptic Processing I 24 140 3360
Aseptic Processing II 24 26 624
Basic Microbiological Lab Skills 16 12 192
Basic Technical Writing 6 90 540
CGMP Overview for Medical Devices 4 119 476
CGMP Overview for Pharmaceuticals 4 591 2364
CGMP Refresher, Biomanufacturing, 8 hours 8 17 136
Cleanroom Gowning Certification 8 16 128
Cleanroom Gowning Concepts 4 16 64
Deviations, Root Cause Analysis and CAPA Resolution 8 114 912
Disinfection, Sterilization, and Containment 6 68 408
Elements of Supplier and Internal Quality Audits 8 6 48
Environmental Monitoring Program for Aseptic Processing 16 6 96
FDA Audit Preparation 8 32 256
Fundamentals of Validation 8 20 160
GMP and SOP 24 18 432
Good Documentation Practices (GDP) and Data Integrity 8 33 264
HPLC in Theory and Practice 16 13 208
Micropipetting Techniques for Precision & Accuracy 8 30 240
Quality Risk Management 8 11 88
Writing Effective SOP's 4 89 356
Totals 1569 12168

2021-2022

Course Lab+Lecture Hours Participants Contact Hours
Advanced Batch Production Records Concepts 4 19 76
Advanced Technical Writing 8 99 792
Aseptic Processing Concepts 12 8 96
Aseptic Processing I 24 33 792
Aseptic Processing II 24 12 288
Basic Technical Writing 6 105 630
Biogen Bootcamp 25 18 450
CGMP Overview for Medical Devices 4 48 192
CGMP Overview for Pharmaceuticals 4 432 1728
Chromatography in Theory & Practice 32 33 1056
Deviations, Root Cause Analysis and CAPA Resolution 8 24 192
Disinfection, Sterilization, and Containment 6 15 90
Downstream 14 3 42
Elements of Supplier and Internal Quality Audits 8 18 144
FDA Audit Preparation 8 20 160
Fundamentals of Validation 8 42 336
Good Documentation Practices (GDP) and Data Integrity 8 7 56
Introduction to Computer Validation 8 14 112
Micropipetting Techniques for Precision & Accuracy 8 4 32
Quality Risk Management 8 12 96
Upstream 16 4 64
Writing Effective SOP's 4 62 248
Totals 1032 7672

2020-2021

Course Lab+Lecture Hours Participants Contact Hours
Active Pharmaceutical Ingredients 24 32 768
Advanced Technical Writing 8 115 920
Aseptic Processing Concepts 12 110 1320
Aseptic Processing I 24 28 672
Aseptic Processing II 24 8 192
Aseptic Refresher 8 58 464
Biogen Bootcamp 25 20 500
CGMP Overview for Medical Devices 4 218 872
CGMP Overview for Pharmaceuticals 4 335 1340
CGMP Refresher, Biomanufacturing, 4 hours 4 126 504
Deviations, Root Cause Analysis and CAPA Resolution 8 119 952
Disinfection, Sterilization, and Containment 6 21 126
Elements of Supplier and Internal Quality Audits 8 19 152
FDA Audit Preparation 8 329 2632
Freeze-Drying Fundamentals 20 4 80
Fundamentals of Validation 8 40 320
Fundamentals of Validation for Medical Devices 8 20 160
Good Documentation Practices (GDP) and Data Integrity 8 23 184
GSK Aseptic Cleaning 4 111 444
Validation Documentation 8 9 72
Validation of Automated Equipment & Process Control Systems 16 6 96
Writing Effective SOP's 4 117 468
Writing Effective Standard Operating Procedures (SOPs) - 8 hours 8 5 40
Totals 1873 13278

2019-2020

Course Lab+Lecture Hours Participants Contact Hours
Advanced Technical Writing 8 117 936
Aseptic Processing I 24 140 3360
Aseptic Processing II 24 39 936
Aseptic Refresher (Grifols Shutdown) 8 211 1688
Biomanufacturing Bootcamp 32 15 480
CGMP Refresher, Biomanufacturing, 2 hours 2 123 246
CGMP Refresher, Biomanufacturing, 4 hours 4 344 1376
Cleanroom Gowning Certification 8 8 64
Computer Application Validation 16 8 128
Freeze-Drying Fundamentals 20 6 120
Fundamentals of Validation 8 74 592
Good Documentation Practices (GDP) and Data Integrity 8 457 3656
Micropipetting - condensed 2.5 116 290
Report Writing: Considerations and Best Practices 8 0 0
Selected Topics in Chromatography - 16 hours 16 12 192
Sterilization and Controlled Temperature Environment Validation 24 11 264
Upstream 16 11 176
Totals 1692 14504

2018-2019

Course Lab+Lecture Hours Participants Contact Hours
Active Pharmaceutical Ingredients 24 35 840
Advanced Technical Writing 8 20 160
Advanced Validation 8 9 72
Aseptic Processing I 24 162 3888
Aseptic Processing II 24 103 2472
Aseptic Refresher 8 59 472
Aseptic Seminar 1 2 26 52
Aseptic Seminar 2 2 25 50
Aseptic Seminar 3 2 25 50
Auditing Techniques (Cosmetics) 8 22 176
Basic Lab Safety - 3 hours 3 21 63
Basic Laboratory Safety and Skills 6 12 72
Basic Technical Writing 6 5 30
CGMP Refresher, Biomanufacturing, 2 hours 2 64 128
CGMP Refresher, Biomanufacturing, 4 hours 4 496 1984
CGMP Refresher, Biomanufacturing, 8 hours 8 28 224
Cleanroom Gowning Certification 8 10 80
Downstream 14 25 350
Elements of Current Good Manufacturing Practices (CGMP) for Biomanufacturing 16 12 192
Elements of Internal Auditing 4 7 28
Elements of Quality Technical Writing 8 12 96
EM/Micro 16 22 352
Freeze-Drying Fundamentals 20 16 320
Fundamentals of Validation 8 27 216
GLP - 6 hours 6 8 48
Good Documentation Practices (GDP) and Data Integrity 8 64 512
Maintenance Controls for Aseptic Operations 8 3 24
Micro Topics - 17 hours 17 8 136
Oral Solid Dose (OSD) Manufacturing 20 41 820
Selected Topics in AP - 16 hours 16 20 320
Selected Topics in Chromatography - 16 hours 16 12 192
Selected Topics in Cleanroom Gowning 8 33 264
Selected Topics in Micropipetting 2.5 20 50
Sterilization and Controlled Temperature Environment Validation 24 11 264
Upstream 16 24 384
Writing Effective Standard Operating Procedures (SOPs) - 8 hours 8 15 120
Totals 1502 15501