PLA Required Skills and Knowledge

Basic molecular genetics topics

• • _____ Nucleic acid structure

  • _____ Protein structure

  • _____ DNA replication process

  • _____ Transcription/ translation process

Recombinant DNA technology

• • _____ Genetic engineering process

  • _____ DNA cloning processes

  • _____ Types of cells commonly used and how these cells are used (CHO/ Bacteria/ Plant)

  • _____ The use of vectors, including the Ti plasmid

Proteins as biotechnology products

• • _____ Uses of proteins in biotechnology

  • _____ Purification of proteins in biotechnology

  • _____ Analysis of proteins used in biotechnology

Applications and impacts of biotechnology

• • _____ Forensic analysis including DNA fingerprinting

  • _____ Processes and products of medical biotechnology

  • _____ Agriculture applications including plants and animals

  • _____ Environmental applications including biofuels

  • _____ Biotechnology research including transgenic/ cloned animals

Bioinformatics

• • _____ The importance of information technology

Ethics

• • _____ The ethics of using/ manipulating living organisms

Government regulations

• • _____ The role of the regulating body, especially the FDA

  • _____ cGMPs, including their purposes and components

Basic laboratory topics

• _____ Demonstrate ability to follow laboratory safety procedures and precautions.

• _____ Demonstrate awareness of the risks associated with a biotechnology laboratory and follow the laboratory chemical hygiene plan and SOPs.

• _____ Identify and safely handle, store, and dispose of hazardous biological, or chemical, or radioactive materials.

• _____ Identify and use appropriate personal protective equipment in the lab.

• _____ Demonstrate good laboratory documentation to include notebook entries, protocol entries and lab equipment generated data.

• _____ Demonstrate knowledge of maintenance and validation of lab equipment.

Government regulations and standards

• _____ Understand the role of the regulating bodies (FDA.gov, OSHA.gov, USDA.gov, and EPA.gov) with respect to biotechnology laboratories.

• _____ Demonstrate the ability to search and find laboratory relevant regulations in the regulatory websites of: FDA.gov, OSHA.gov, USDA.gov, and EPA.gov.

• _____ Understand the role of the standardization bodies (ISO.org, ICH.org, and ANSI.org) with respect to biotechnology laboratories.

• _____ Recognize and understand the purpose and components of cGXPs (cGLP, cGMP, cGDP, cGCP, and cGEP).

Drug and Medical Device manufacturing topics

• _____ Demonstrate ability to understand the biomanufacturing drug and medical device processes.

• _____ Demonstrate awareness of reporting compliance of drugs and medical devices.

• _____ Demonstrate regulatory compliance issues throughout product life cycle.

• _____ Demonstrate risk management implementation throughout the medicinal products manufacturing processes.

• _____ Demonstrate good manufacturing documentation.

• _____ Demonstrate knowledge of maintenance and validation of manufacturing equipment.

Government regulations and standards

• _____ Understand the role of the regulating body FDA.gov with respect to the medicinal products manufacturing processes.

• _____ Demonstrate the ability to search and find relevant regulations on the regulatory website of FDA.gov with respect to the medicinal products manufacturing processes.

• _____ Understand the role of the standardization bodies (ISO.org, ICH.org, and ANSI.org) with respect to the medicinal products manufacturing processes.

• _____ Recognize and understand the purpose of cGLP, cGMP, cGDP, and cGCP with respect to the medicinal products manufacturing processes.

Note: PLA for this course is available for students currently working in the Biotechnology Industry

1. Demonstrate mastery of the documentation practices appropriate to their primary work assignment. ______

2. Demonstrate an understanding and appropriately comply with the safety environment associated with the company at large and with their primary work assignment. ______

3. Demonstrate technical growth. This includes deeper understanding of the theoretical and technical details associated with their primary work assignment and with the activities of the company at large. ______

4. Demonstrate mastery of those proficiencies required to carry out their primary assignment. ______

5. Demonstrate behaviors, workplace skills and ethics appropriate to the workplace of their primary work assignment. ______

6. Demonstrate an understanding of the regulatory environment that applies to the company of their assignment and will demonstrate capacity to comply with the regulatory environment. _____

7. Demonstrate an understanding of the business and economic considerations of the corporate environment. _____

8. Demonstrate an understanding of their role in the quality of the product going to the consumer. _____

9. Demonstrate increased understanding and/or proficiency in three of the following areas: _____

• • • Aseptic operation including environmental monitoring techniques, gowning requirements, sterilization and sanitization and cleaning;

    • Bioburden control techniques;

    • Proper use of equipment and control by ensuring proper function, storage, record keeping;

    • Product formulation; Application of MS to protein analysis;

    • Application of various immunological based high-throughput analysis techniques;

    • Industrial and/or research applications of gas chromatography;

    • Applications of bioassays in product development and testing;

    • Techniques used in elemental analysis; Industrial and research applications of bioinformatics;

    • Research and/or industrial use of radioisotopes;

    • Application of mutagenesis in product development and testing;

    • Heat and mass transfer as it applies to process equipment.