Spring 2027

Topics in Quality Assurance and Regulatory Affairs in Biotechnology

Case-study course on applying QA and regulatory compliance systems to bring medical devices to market within the biotechnology industry.

offering recorded3 credits
Recorded instructors · Spring 2027 Kashif SheikhNatalie Betz

Summary

What you’ll be able to do

  • Evaluate quality systems used in product development and commercialization of medical devices.

  • Influence medical device development and project vision from quality assurance and regulatory affairs standpoints.

  • Produce quality and regulatory strategies to achieve organizational objectives of medical devices.

  • Compose effective communication with colleagues, customers, and regulatory agencies.

  • Troubleshoot design and manufacturing issues of medical device development to meet regulatory standards.

  • Monitor how diverse teams fit into organizational culture and successfully contribute towards product development.

Source: UW Guide

Grade history

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average GPA
letter grades

No recorded grade history.

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Prerequisites

Course map

Declared in the Capstone Certificate in Quality Assurance and Regulatory Affairs in Biotechnology

  • Declared in the Capstone Certificate in Quality Assurance and Regulatory Affairs in Biotechnology
BIOMDSCI 721

This is a best-effort interpretation; check the catalog requirements above.

Prerequisite text tree
  • Declared in the Capstone Certificate in Quality Assurance and Regulatory Affairs in Biotechnology

Professors

Spring 2027
Historical instructors & teaching patterns

KASHIF SHEIKH is recorded teaching in Spring 2026. Recorded history may be incomplete and does not establish a future schedule.

NATALIE BETZ is recorded teaching in Spring 2026. Recorded history may be incomplete and does not establish a future schedule.

Recorded history may be incomplete and does not establish a future schedule.

Calendar & sections

Spring 2027

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SectionModeEnrolled / capacityWaitlist
LEC 001Online Only0 / 300

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Meeting source records

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Student experience

the class

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.

difficulty & workload

No workload feedback recorded.

Topics

  • Quality assurance and regulatory compliance systems for medical devices.
  • Product development in the biotechnology industry.
  • Cross-functional teamwork for meeting safety regulations.

Skills

  • Evaluate quality systems and troubleshoot design/manufacturing issues for medical devices.
  • Develop quality and regulatory strategies to influence medical device development.
  • Collaborate in cross-functional teams to meet regulatory safety standards.

Grades

Instructor

Grade distribution · % of letter grades

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More grade details Grade mix, volume & source data

Sources & history

UW–Madison

Catalog & offerings

Descriptions, prerequisites, and recorded course offerings.

Catalog observation history

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Selected offering source records
BIOMDSCI 721 · Spring 2027

Topics in Quality Assurance and Regulatory Affairs in Biotechnology

Recorded 2026-10-14
Raw records 
[
  {
    "run_id": "20261014T203208-0851c9a1",
    "semester": "1274",
    "observed_at": "2026-10-14 17:50:09.728220+00:00",
    "offering_id": "1274:209:026795",
    "course_id": "BIOMDSCI 721",
    "course_uid": "course_393acf60c6598c7d409d4ee8",
    "term_id": "1274",
    "source_course_id": "026795",
    "source_subject_id": "209",
    "title": "Topics in Quality Assurance and Regulatory Affairs in Biotechnology",
    "credits_min": 3,
    "credits_max": 3,
    "typically_offered": "Not Applicable"
  }
]
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Madgrades

Grade history

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Dataset & model

Recorded 2026-10-14

View the dataset on Hugging Face
Model outputs & technical records
Qwen/Qwen3.8-27B
LLM outputs across runs
Download part 1
Full model traces

Recorded model configuration, reasoning, and tool conversations.

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Model & dataset provenance 
{
  "model": "Qwen/Qwen3.8-27B",
  "model_revision": "1d4bf0f2ff6012fd82039f2fa52739d0dd7c60c0",
  "task_version": "17",
  "output_id": "aaa8d0e6d866b77e2c684a3a8af42ac121343b94cc63c4ffaa5887fe46cc5646",
  "requirements_status": "needs_review",
  "dataset_revision": "fc1811fa52e581ea57a35c0cf3343f8740a8ffbf",
  "observed_at": "2026-10-14 17:50:09.728220+00:00"
}