# BIOMDSCI 721: Topics in Quality Assurance and Regulatory Affairs in Biotechnology | UW–Madison [View on UW Courses](https://uwcourses.com/courses/BIOMDSCI_721) ## Dataset ### revision e243353dcb7d79b7247ced91d69443ef4c2a6349 ### repository twangodev/uwcourses ### schema version 6 ### importer version 7 ### projection id 94468b7d4154126ca413937bb4738a6d21e0c2277f6fa397a6078ad80a32384f ### observed at 2026-09-07T15:55:43.033547+00:00 ### built at 2026-09-10T23:19:01.870283+00:00 ### courses 8951 ### current instructors 5754 ### limited false ### terms * 1272 * 1264 * 1262 * 1254 * 1252 * 1244 * 1242 * 1234 * 1232 * 1224 * 1222 * 1212 * 1204 * 1202 * 1194 * 1192 * 1184 * 1182 * 1174 * 1172 * 1164 * 1162 * 1154 * 1152 * 1144 * 1142 * 1134 * 1132 * 1124 * 1122 * 1114 * 1112 * 1104 * 1102 * 1094 * 1092 * 1084 * 1082 * 1074 * 1072 ### term 1272 ### departments | subject | count | | --------- | ----- | | AAE | 90 | | ABT | 20 | | ACCTIS | 36 | | ACTSCI | 14 | | AFAERO | 10 | | AFRICAN | 87 | | AFROAMER | 71 | | AGROECOL | 21 | | AMERIND | 53 | | ANAT\&PHY | 7 | | ANATOMY | 2 | | ANESTHES | 8 | | ANSCI | 57 | | ANTHRO | 95 | | ART | 125 | | ARTED | 10 | | ARTHIST | 121 | | ASIALANG | 129 | | ASIAN | 109 | | ASIANAM | 28 | | ASTRON | 38 | | ATMOCN | 69 | | BIOCHEM | 51 | | BIOCORE | 10 | | BIOLOGY | 14 | | BIOMDSCI | 18 | | BME | 66 | | BMI | 41 | | BMOLCHEM | 10 | | BOTANY | 69 | | BSE | 44 | | C\&ESOC | 73 | | CBE | 48 | | CHEM | 101 | | CHICLA | 52 | | CIVENGR | 133 | | CLASSICS | 47 | | CNP | 10 | | CNSRSCI | 50 | | COMARTS | 137 | | COMPBIO | 15 | | COMPLIT | 11 | | COMPSCI | 138 | | COUNPSY | 78 | | CRB | 19 | | CS\&D | 71 | | CSCS | 40 | | CURRIC | 193 | | DANCE | 93 | | DERM | 8 | | DS | 88 | | DYSCI | 35 | | ECE | 155 | | ECON | 145 | | EDPOL | 114 | | EDPSYCH | 97 | | ELPA | 70 | | EMA | 53 | | EMERMED | 17 | | ENGL | 206 | | ENTOM | 40 | | ENVIRST | 148 | | EP | 15 | | EPD | 67 | | ESL | 16 | | F\&WECOL | 60 | | FAMMED | 22 | | FINANCE | 50 | | FOLKLORE | 40 | | FOODSCI | 43 | | FRENCH | 63 | | GEN\&WS | 145 | | GENBUS | 72 | | GENECSLR | 17 | | GENETICS | 60 | | GEOG | 113 | | GEOSCI | 83 | | GERMAN | 82 | | GLE | 48 | | GNS | 38 | | GREEK | 27 | | HDFS | 41 | | HEBR-BIB | 13 | | HEBR-MOD | 10 | | HISTORY | 233 | | HISTSCI | 56 | | HONCOL | 13 | | ILS | 43 | | INFOSYS | 9 | | INTEGART | 7 | | INTEGSCI | 22 | | INTER-AG | 18 | | INTER-HE | 11 | | INTER-LS | 22 | | INTEREGR | 16 | | INTLBUS | 21 | | INTLST | 50 | | ISYE | 83 | | ITALIAN | 53 | | JEWISH | 56 | | JOURN | 88 | | KINES | 128 | | LACIS | 26 | | LANDARC | 61 | | LATIN | 24 | | LAW | 120 | | LEGALST | 48 | | LINGUIS | 35 | | LIS | 89 | | LITTRANS | 78 | | LSC | 52 | | M\&ENVTOX | 7 | | MARKETNG | 62 | | MATH | 153 | | MDGENET | 8 | | ME | 130 | | MEDHIST | 43 | | MEDICINE | 60 | | MEDIEVAL | 32 | | MEDPHYS | 39 | | MEDSC-M | 29 | | MEDSC-V | 41 | | MHR | 68 | | MICROBIO | 45 | | MILSCI | 16 | | MM\&I | 22 | | MOLBIOL | 6 | | MS\&E | 59 | | MUSIC | 165 | | MUSPERF | 126 | | NAVSCI | 20 | | NE | 44 | | NEURODPT | 11 | | NEUROL | 7 | | NEURSURG | 4 | | NTP | 11 | | NURSING | 111 | | NUTRSCI | 65 | | OBS\&GYN | 18 | | OCCTHER | 39 | | ONCOLOGY | 14 | | OPHTHALM | 5 | | OTM | 43 | | PATH | 34 | | PATH-BIO | 29 | | PEDIAT | 26 | | PHARMACY | 31 | | PHILOS | 77 | | PHMCOL-M | 11 | | PHMPRAC | 45 | | PHMSCI | 60 | | PHYASST | 37 | | PHYSICS | 88 | | PHYSIOL | 3 | | PHYTHER | 37 | | PLANTSCI | 52 | | PLPATH | 35 | | POLISCI | 192 | | POPHLTH | 58 | | PORTUG | 33 | | PSYCH | 101 | | PSYCHIAT | 22 | | PUBAFFR | 54 | | PUBLHLTH | 23 | | RADIOL | 11 | | REALEST | 41 | | RELIGST | 90 | | RHABMED | 9 | | RMI | 24 | | RP\&SE | 102 | | S\&APHM | 17 | | SCANDST | 73 | | SLAVIC | 89 | | SOC | 149 | | SOCWORK | 87 | | SOILSCI | 46 | | SPANISH | 83 | | SRMED | 21 | | STAT | 94 | | STDYABRD | 52 | | STS | 8 | | SURGERY | 25 | | SURGSCI | 33 | | THEATRE | 91 | | URBRPL | 60 | | UROLOGY | 5 | | ZOOLOGY | 89 | ## course ### run id 20260907T155543-ce3781c4 ### semester 1272 ### observed at 2026-09-07 15:55:43.033547+00:00 ### record version id 035d0da312fbd67928317fde69d188a61121b32335c467ee4a4510c8f78e01ef ### course id BIOMDSCI 721 ### course uid course\_393acf60c6598c7d409d4ee8 ### catalog version id 77c9c7fb0e1c0e38d55aebf79178941ae0d1e09101343b0129f838a385944590 ### course number 721 ### subjects * BIOMDSCI ### title TOPICS IN QUALITY ASSURANCE AND REGULATORY AFFAIRS IN BIOTECHNOLOGY ### description Quality Assurance and Regulatory Affairs departments influence and facilitate successful product development within the biotechnology industry. Use a case study approach to explore and apply how quality assurance and regulatory compliance systems are used to bring medical devices to market. Practice how cross functional teams work together to meet regulatory standards of safety. ### requirements text Declared in the Capstone Certificate in Quality Assurance and Regulatory Affairs in Biotechnology ### credit offering ids None recorded. ### llm job id enrich-8b774950c2b6adfdc46d1b82 ### llm output id adeed4f43ea1b65035b3332035971307a59400c6a07bd5590e6e5137d69a69f4 ### llm model nvidia/Qwen3.6-35B-A3B-NVFP4 ### llm model revision 1355db6a052410cfd62085d94b58866fd0f2c3c5 ### llm task version 14 ### llm search status valid ### llm summary BIOMDSCI 721 uses case studies to teach quality assurance and regulatory compliance systems for bringing medical devices to market. ### llm topics * Quality Assurance and Regulatory Affairs in Biotechnology * Product development within the biotechnology industry ### llm skills * Applying quality assurance and regulatory compliance systems for medical device market entry * Collaborating in cross-functional teams to meet regulatory safety standards ### llm assumed background None recorded. ### llm search phrases * biotechnology quality assurance regulatory affairs * medical device regulatory compliance case study * cross functional teams regulatory standards safety ### llm requirements status valid ### llm student summary status valid ### llm experience status insufficient\_evidence ### catalog variants None recorded. ### student summary #### context hash ea26325510b89d16c4aab5a595019fdb971a75cfbb44a0d9b2f19f2d2331599d #### course id BIOMDSCI 721 #### current instructors None recorded. #### difficulty workload None recorded. #### errors None recorded. #### historical context None recorded. #### message No course-specific reviews available #### offered false #### profile hash 672f506f2fc2f46a071b9777f4a92cc197b2ccdeef25590e9285146d8c7e7f90 #### quick take None recorded. #### student experience None recorded. #### task hash 74fb0997943e888960bbc9e47db8c4fd12e4292d55c20509d8d89db6a9910f68 #### teaching history None recorded. #### term id 1272 #### term name 2026 Fall #### version 2 ### requirements #### nodes ```json [ { "children": [], "condition": "Declared in the Capstone Certificate in Quality Assurance and Regulatory Affairs in Biotechnology", "course": null, "evidence": "Declared in the Capstone Certificate in Quality Assurance and Regulatory Affairs in Biotechnology", "id": "n0", "kind": "condition" } ] ``` #### notes None recorded. #### root n0 #### status parsed ### instructors None recorded. ### offerings None recorded. ### sections None recorded. ### grade instructors ```json [ { "instructor_uid": "instructor_6d21bc07da00876f9cee3356", "source": "madgrades", "source_instructor_id": "948165", "identity_basis": "source_id", "identity_status": "source_identified", "name": "NATALIE BETZ", "email": null, "first_observed_at": "2026-09-06 23:14:58.172943+00:00", "last_observed_at": "2026-09-07 15:55:43.033547+00:00", "grade_statistics": { "gpa": 3.745, "graded": 1840, "counts": [ 1199, 444, 130, 46, 18, 0, 3 ], "sections": 184 }, "instructor_url": "/instructors/NATALIE_BETZ--instructor_6d21bc07da00876f9cee3356" }, { "instructor_uid": "instructor_c70ef62d62801b048df0d529", "source": "madgrades", "source_instructor_id": "1001172", "identity_basis": "source_id", "identity_status": "source_identified", "name": "LINDA MILLER", "email": null, "first_observed_at": "2026-09-06 23:14:58.172943+00:00", "last_observed_at": "2026-09-07 15:55:43.033547+00:00", "grade_statistics": { "gpa": null, "graded": 0, "counts": [ 0, 0, 0, 0, 0, 0, 0 ], "sections": 1 }, "instructor_url": "/instructors/LINDA_MILLER--instructor_c70ef62d62801b048df0d529" }, { "instructor_uid": "instructor_e6fb00f68222673248668f81", "source": "madgrades", "source_instructor_id": "6800848", "identity_basis": "source_id", "identity_status": "source_identified", "name": "KASHIF SHEIKH", "email": null, "first_observed_at": "2026-09-06 23:14:58.172943+00:00", "last_observed_at": "2026-09-07 15:55:43.033547+00:00", "grade_statistics": { "gpa": null, "graded": 0, "counts": [ 0, 0, 0, 0, 0, 0, 0 ], "sections": 1 }, "instructor_url": "/instructors/KASHIF_SHEIKH--instructor_e6fb00f68222673248668f81" } ] ``` ### grades ```json [ { "run_id": "20260907T155543-ce3781c4", "semester": "1272", "observed_at": "2026-09-07 15:55:43.033547+00:00", "course_id": "BIOMDSCI 721", "course_uid": "course_393acf60c6598c7d409d4ee8", "term_id": "1264", "term_name": "Spring 2026", "instructors": [ "KASHIF SHEIKH", "LINDA MILLER", "Natalie Betz" ], "a": 0, "ab": 0, "b": 0, "bc": 0, "c": 0, "d": 0, "f": 0, "satisfactory": 0, "unsatisfactory": 0, "credit": 0, "no_credit": 0, "passed": 0, "incomplete": 0, "no_work": 0, "not_reported": 0, "other": 0, "total": 0, "source_aliases": [ "BIOMDSCI 721" ] } ] ``` ### statistics #### graded 0 #### counts * 0 * 0 * 0 * 0 * 0 * 0 * 0 ### grade conflicts None recorded. ### evidence #### history * 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