JBA Written Exam study plan

Map the four biosafety levels (BSL-1 to BSL-4) to their required facility features, primary and secondary containment barriers, and typical agents handled at each level

Explain how directional airflow, HEPA filtration on supply and exhaust, and pressure differentials maintain containment in a BSL-3 laboratory

Describe the operating rules for biological safety cabinets: Class I, II, and III differences, airflow verification, certification intervals, and when cabinet use is required

Outline decontamination, waste handling, and autoclave validation requirements for a containment facility

List the routine facility maintenance and monitoring tasks (pressure checks, filter changes, alarm testing) that keep a containment lab in compliance

Apply the five-step risk assessment process (agent hazard, activity, containment, risk evaluation, review) to at least three sample laboratory scenarios

Classify biological agents by risk group and justify the containment level selected for each scenario

Identify routes of exposure, infectious dose considerations, and vulnerable populations when assessing risk

Explain how procedures involving sharps, aerosols, and large-volume cultures raise assessed risk and what mitigation follows

Document a risk assessment using a structured template with hazards, controls, and residual risk rating

Describe the components of a biological resource management system: acquisition, inventory, storage, transfer, and destruction of biological materials

Explain the requirements for a culture collection or stock center, including authentication, viability testing, and backup storage

Outline quality control testing performed on reference strains and cell lines (identity, purity, sterility, mycoplasma testing)

Describe chain-of-custody and material transfer documentation for biological resources

Explain how biosafety and biocontainment requirements apply to storage and shipment of biological materials

Design a quality control testing schedule for a biological resource facility, specifying test, frequency, acceptance criteria, and responsible role

Explain how proficiency testing, internal audits, and corrective action systems maintain resource quality

Describe traceability requirements linking a stored material to its source, passage history, and test records

Compare quality control expectations for master cell banks versus working cell banks

Identify common failure modes in biological resource management (misidentification, contamination, inventory loss) and the controls that prevent them

Map the regulatory framework governing bioindustry: national biosafety laws, GMO handling rules, and relevant international standards and guidelines

Explain the structure and intent of Good Manufacturing Practice requirements: premises, equipment, documentation, personnel, and validation

Describe the role of quality assurance versus quality control and how deviation, change control, and CAPA systems interact

Outline the documentation hierarchy (policy, standard operating procedure, batch record, record) and data integrity expectations

Explain inspection readiness: what regulators examine and how audit findings are classified and closed

Explain core biotechnology applications: recombinant protein production, monoclonal antibody development, cell and gene therapy, and molecular diagnostics

Describe the upstream and downstream process steps for a biopharmaceutical product and where critical quality attributes are controlled

Explain how process validation (including continued process verification) demonstrates consistent product quality

Describe sterilization, aseptic processing, and environmental monitoring requirements for sterile biologics

Connect biotechnology process steps to the GMP controls that apply at each stage

Explain ethical principles governing biological research: informed consent, dual-use research of concern, animal welfare, and responsible publication

Describe environmental health and safety requirements: chemical and biological waste segregation, spill response, occupational exposure and post-exposure procedures

Outline the requirements for institutional oversight bodies (biosafety committee, ethics committee, IACUC) and their review processes

Explain compliance obligations for incident reporting, adverse event handling, and whistleblower protections

Identify conflicts between research goals and compliance obligations and how they are resolved

Consolidate all seven domains into a weighted review schedule that allocates time proportional to exam weighting

Complete a full-length timed practice set and analyze errors by domain to identify the two weakest areas

Re-teach the weakest two domains from notes and verify understanding with a fresh set of questions

Memorize high-frequency facts: containment level requirements, GMP documentation rules, risk assessment steps, and reporting obligations

Simulate exam conditions with a second timed set and confirm a score improvement over the first attempt