Lesson Plan Summary Sheet

Teacher: Howerton

Subject: Biotech I

Topic: Regulation of Biotech

Date / Essential Question(s) / Activities / Vocabulary / Summarizing Strategies
11/23 / What is the role and organization of FDA?
What regulatory practices does the FDA require to ensure safe and effective biotech products? /
  • Log into FDA website and complete the scavengerhunt worksheet
  • View the FDA Overviewpowerpoint
  • View Regulatory Overview powerpoint
/ Adulterated
Compliance
Regulate
QSR
ISO
GMP / C1:Explain to an absent student about the FDA
11/24 / Why and how are standard operating procedures (SOPs) written? /
  • View the FDA Overview powerpoint
  • View Regulatory Overview powerpoint
  • Students will write an SOP on how to make a quart of Kool-Aid
  • Preview the Easy A Project
/ SOP / C2:Explain the main purpose of a SOP.
11/30-12/1 / How are Good Laboratory Practices (GLP) used to support the development of safe and effective biotech products? /
  • Design an study to investigate the affect the dosage of chocolate has on heart rate.
  • Create all necessary SOPs and documentation to comply with GLP
/ GLP / C3:Explain the main purpose of a GLP.
12/2-3 / How are clinical studies used to support the development of safe and effective biotech products? /
  • View the Clinical Studies powerpoint
  • Design a study that investigates which type of chocolate people prefer
  • Create all necessary documentation to receive IRB approval.
/ Primary investigator
Single blind study
Double blind study
Internal Review Board
Ethics
Placebo
Statistical analysis
Outliers
Mean
Standard deviation
Significance / C4:Explain the main purpose of a clinical studies.
12/4- 7 / How are Current Good Manufacturing Practices (cGMP) used to support the manufacturing of safe and effective biotech products? /
  • View the cGMPpowerpoint
  • Design a schematic for the manufacturing of the Easy A nutritional supplement cookies that considers all aspects of GMP from raw materials to finished product.
  • Create all necessary documentation to comply with cGMP
/ Batch record
Non-conformance
Quality assurance
Quality control
Deviation / C5:Explain the main purpose of a cGMP.
12/8 / What are some regulations for labeling and marketing a biotech product?
What are regulatory audits in the biotech industry? /
  • View the Labeling and Marketing powerpoin
  • Create appropriate labeling for your Easy A Cookies and package them accordingly.
  • View the Auditing powerpoint
  • Review the entire manufacturing process and create an audit document to support GMP
/ Code of Federal Regulations
Inserts
Pharmacology
Indications/
Contraindications
Auditing
Validation
Tolerance
Capacity / C6:Explain what information needs to be covered when labeling a product.
C7:Explain the purpose of an audit.none
12/9 / How is the biotech industry regulated to ensure safe and effective products? /
  • Review
/ none / C8: Write a reflection on this unit. What did you learn? How could your effort be improved on?
12/10 / How is the biotech industry regulated to ensure safe and effective products? /
  • Test on Biotech Regulation
  • Vocabulary and Summarizing Strategies are due***
/ none