BIOTECHNOLOGY QUALITY AND REGULATIONS TRAINING
OVERVIEW AND SCHEDULE
Submitted by Vivian Ngan-Winward, Vivian.ngan-winward@slcc.edu
Salt Lake Community College
Bio-Link Courses-in-a-Box
BIOTECHNOLOGY QUALITY AND REGULATIONS TRAINING
DESCRIPTION: This is a four day training course contributed by Dr. Vivian Ngan-Winward that is intended for instructors who want to teach
quality and regulations in their own schools. The course includes lectures, classroom activities, and one laboratory exercise.
Note that Dr. Ngan-Winward’s students are encouraged to take an ASQ certification exam to become a “Certified Quality Improvement
Associate, CQIA.” The lectures in this course therefore include general quality topics not specific to the biotechnology industry that relate to this
certification exam.
The following materials from Dr. Ngan-Winward’s course are provided in this collection:





Lectures – PowerPoint presentation and course materials in PDF format
Descriptions of class activities and accompanying activity documents
Description of laboratory activity
A document describing the body of knowledge for an ASQ Certified Quality Improvement Associate
Relevant reference documents
COURSE OVERVIEW:
TIME
Day 1
TOPICS
TYPE
Biotechnology Industry Overview
Research and Development
Manufacturing Process
Lecture
Production Considerations
Lecture
Quality Regulations – An Abbreviated History and Influences
Quality Evolution: Influential People
Regulations Evolution: Landmark Laws and Origin of the FDA
Lecture
Variation – Impacts on Quality
Lecture
Managing Variation Simulation
Activity
2
Bio-Link Courses-in-a-Box
Day 2
BIOTECHNOLOGY QUALITY AND REGULATIONS TRAINING
Statistical Process Control Charts
Activity
Quality and Regulatory Relationships
Lecture
Food and Drug Administration
Overview
Organization
Biotech Product Jurisdiction
Regulated Product Approvals
Drugs
Medical Devices, Classification, and Substantial Equivalence
FDA Web Site Resources
Lecture
Review of Day 1 Topics
Quiz
The Laws (U.S. Code) and Federal Regulations
Laws → Regulations
Laws Impacting the FDA
FD&C Act Overview
21 CFR Overview
Summary of Select 21 CFR Parts
Good <???> Practices (GXPs), Different GXPs
Good Laboratory Practices (GLP), What are GLPs?
Good Manufacturing Practices (GMP), What are GMPs?
Medical Device GMPs (21 CFR 820) Example
FDA QSR Introduction
GMP Design Controls
Lecture
3
Website
Demo
Lecture
Bio-Link Courses-in-a-Box
BIOTECHNOLOGY QUALITY AND REGULATIONS TRAINING
GXP Comparison
Day 3
Activity
ISO:
Governing Body
9000 Series Standards Family
ISO 9001:2008 Quality Management System -- Requirements
Lecture
Quality Management System (QMS):
Key Elements of Quality
Controlling and Improving Quality
Vocabulary
PDCA Cycle
Quality Activities
Lecture
QMS Process Model
Lecture
Review of Day 2 Topics
Quiz
Understanding Teams
Purposes of a Team
Team Member Roles
Team Success
Team Stages
Lecture
Self-Assessment
Activity
QMS Documents
Document Types and Examples
Lecture
Writing QMS Documents
SOP and WID Elements
Considerations
4
Bio-Link Courses-in-a-Box
BIOTECHNOLOGY QUALITY AND REGULATIONS TRAINING
Writing Documents
Day 4
Review of Day 3 Topics
Activity
Quiz
Validating QMS Documents: SOPs and WIDs
Activity
QMS Documents – Discussion and Debrief
Considerations
STUDENTfactured – Good Manufacturing Practices Show and Tell
Additional Vocabulary
Lean Manufacturing Terms
Six Sigma
FDA Inspection – Form 483 Example
Discussion
ACTIVITY DETAILS:

Managing Variation Simulation
The purpose of this activity is to demonstrate how the management method will impact how well variation becomes
managed. The activity uses a children’s marble maze kit to simulate a drug manufacturing process. Prior to mass
producing a drug product, the manufacturing process must be scaled up from pilot or smaller scale and then validated.
Validation should only be performed when the process has been optimized. If not, changes will ensue, requiring costly
revalidation.
The activity is comprised of 3 trials of building a validated maze/drug manufacturing process, making several runs/drug
batches, and adjusting the maze/process to manage variation in the runs/batches. Each trial will be performed with
slightly different instructions, with the final one being the “money” trial.
The results of these 3 trials should demonstrate that methodical and data-driven management of variation yields better
results and maximizes profit!

Statistical Process Control Charts
5
Bio-Link Courses-in-a-Box
BIOTECHNOLOGY QUALITY AND REGULATIONS TRAINING
The purpose of this activity is to demonstrate how data plotted in the form of statistical process control (SPC) charts can
be used to distinguish common from special causes of variation as well as to assist in variation management.
The activity is comprised of plotting one (or more if desired) sets of data in a SPC chart, complete with center, upper
control limit, and lower control limit lines, and then analyzing the chart to determine whether the process is in or ourt of
control, based on chart analysis rules provided.
This activity should demonstrate how SPC charts might be used to track repeated processes in the lab and to control
associated variation.

GXP Comparison
The purpose of this activity is to compare GLP, drug cGMP, biologics cGMP, and medical device cGMP/QSR to determine
the similarities and differences among these different GXPs.
The activity is comprised of cutting up the tables of contents for each of the GXPs and aligning those topics that are
similar.
This activity should demonstrate that there are considerable similarities among the different GXPs.

Self-Assessment
The purpose of this activity is for each course participant to determine the kind of contributor he/she would be in a team
and project.
The activity is comprised of a self-assessment quiz that each participant completes, scores, and analyze for contributor
type: Creator, Connector, Developer, or Doer.
By understanding the type of contributor he/she is as well as that of the other team members, each participant will be
better able to contribute to achieving the team’s objectives and goals.

Writing Documents
The purpose of this activity is to gain practical experience writing typical quality system documents, specifically work
instructions and batch records. Work instructions are lower-level documents that provide step-by-step detail on how to
complete a task. Batch records are forms that are filled out while a task is completed per work instructions. A work
instruction document is usually used in conjunction with a batch record to capture the exact work done.
6
Bio-Link Courses-in-a-Box
BIOTECHNOLOGY QUALITY AND REGULATIONS TRAINING
The activity is comprised of participants forming groups, each responsible for drafting a work instruction/batch record set
for one biotechnology lab task in a sequence of tasks. This activity is linked to the next activity, validating documents.

Validating Documents
The purpose of this activity is to gain practical experience validating written documents and observing firsthand how
important properly written documents are to the successful achievement of the desired outcome.
The activity is comprised of trading the written work instruction and batch record set among the groups formed
previously so that each group performs a task per work instructions written by another group.
This activity in conjunction with the previous activity should demonstrate how to write effective documents and validate
them.
7