RAPS RAC-GS Exam Prep
Regulatory Affairs Certification (RAC) Global Scope (Page 8 )

• Which batches and markets are affected
• Whether the deficiency affects product quality, efficacy, or patient safety
• Whether the issue is an ongoing manufacturing problem
• Whether immediate containment or distribution suspension is needed

• A — Withdraw the product: may be necessary, but is premature before assessing the risk.
• B — “Dear Dr.” letter: may be appropriate later, depending on the risk.
• C — Notify global authorities: may become mandatory, but the scope and urgency depend on the assessment.

• Deficiency found before patient use: usually does not require an adverse-event report because no patient exposure occurred.
• Event caused solely by the patient’s condition: may not be reportable if the device did not contribute.
• Malfunction protection operated correctly: generally exempt when the device’s safety mechanism worked as intended and prevented harm.

• Correct answer: D — Promote off-label use to a carefully selected patient population.

• Conditional approval means confirmatory studies are still required. To minimize risk during this period, you should implement risk minimization actions that keep use within approved terms.
• Labeling for appropriate populations ensures clinicians and patients know exactly who the product is intended for.
• Educating patients and healthcare providers reduces misuse and misinterpretation of how to use the product.
• Delaying product launch limits patient exposure to potential unknown risks until safety/efficacy are confirmed.
• Promoting off-label use is least effective (and inappropriate): it increases risk, bypasses approved indications, and undermines regulatory commitments. Off-label use lacks the evidentiary basis and regulatory safeguards of approved indications.

• Warehouse size: Larger warehouses use more credits per unit of time than smaller ones.
• Number of clusters: A multi-cluster warehouse can run multiple clusters, and each active cluster consumes credits. Therefore, increasing the maximum or active cluster count can increase consumption.

• Number of users: More users may cause more workload, but users themselves do not consume credits.
• Amount of data processed: Snowflake warehouses are not charged directly by the amount of data scanned. However, processing more data may cause the warehouse to run longer, indirectly increasing credits.

• Frequency/likelihood = how often or how likely the risk is to occur.
• Severity/impact = how damaging or costly the consequences would be.

• A minor equipment fault occurring frequently may have high frequency but low severity.
• A major cyberattack occurring rarely may have low frequency but high severity.
• A risk that happens often and causes substantial losses has high frequency and high severity.

• A — Technical review by business owner: A business owner may approve the business impact, but a technical review is normally performed by technical personnel.
• C — Cost-benefit analysis after implementation: Cost-benefit analysis should occur before implementation to support the approval decision.
• D — Business continuity testing: This can be appropriate for major changes, but it is primarily part of business continuity and disaster recovery planning—not a universal change-management activity.

• \Pipeline1
• \Folder1\Lakehouse1

• Pipeline1 remains at the workspace root in Workspace1, so it is deployed to the root of Workspace2.
• Lakehouse1 was moved into Folder1, so its full path is preserved as \Folder1\Lakehouse1.
• Fabric deployment pipelines preserve folder paths because an item’s full path is treated as part of its name.

• A. Remove rows where Sales[Status] is Canceled

• E. Remove Sales[Canceled Date]

• B: Removing Sales_Date would remove information users need—the date portion.
• C: Changing Delivery_Time to Integer could alter its meaning or precision and is not necessarily safe.
• D: Splitting the date/time column creates additional columns rather than simply removing unnecessary data.

DAX 
Blue Sales = 
CALCULATE( 
    [Total Sales], 
    KEEPFILTERS('Product'[Color] = "Blue") 
)

• CALCULATE evaluates [Total Sales] after applying an additional filter.
• 'Product'[Color] = "Blue" restricts the calculation to blue products.
• KEEPFILTERS ensures the existing filter context is preserved. For example, filters for year, region, or customer remain active. If Color is already filtered, the blue condition is applied as an intersection rather than replacing the existing filter.
• Avoid ALL, because it removes filters and would not maintain the existing context.

• A — Use a custom controller: An Apex class can contain the page’s logic.
• C — Use a standard controller with extensions: The standard controller provides basic CRUD behavior, while an extension adds custom logic.
• E — Use a standard controller: Useful when the page works mainly with one Salesforce object and needs standard functionality.

• A page with no controller for static or controller-free content.
• A custom controller with extensions; extensions are not limited only to standard controllers.

1. Discovery tries the SSH probe first.
2. SSH fails.
3. Discovery tries SNMP, which succeeds.
4. Discovery records SNMP as the preferred service for that IP.
5. Future discoveries try SNMP first.

• Classification identifies the type of device, such as a server, router, or printer.
• Credential affinity remembers which credentials work for a device.
• MID Server affinity associates a device or network with a particular MID Server.
• IP service affinity specifically controls the preferred discovery protocol or service.

• Response and resolution time frames
• Availability or uptime requirements
• Performance targets
• Support obligations
• Penalties for failing to meet requirements

• SOW (Statement of Work): Defines the project’s scope, tasks, and deliverables.
• MOA (Memorandum of Agreement): Describes cooperation and responsibilities between parties.
• MOU (Memorandum of Understanding): Records a general mutual understanding, usually without detailed enforceable service targets.

• A password cracker would normally be identified by behavior such as loading password hashes or attempting dictionary/brute-force attacks.
• The question describes a routine audit, not password recovery.
• Simply encountering a protected file during an audit is characteristic of a misconfigured or insufficiently privileged FIM.

• New investment: $536,500
• Resulting NPV: $0

• Honeypots: Decoy systems designed to attract attackers. Legitimate users should not access them, so activity there is a strong indication of unauthorized access.
• DNS sinkholes: Redirect requests for known malicious domains to a controlled internal destination instead of the real attacker infrastructure. Security teams can then identify infected systems making those requests.

• Tokenization: Replaces sensitive data with non-sensitive tokens; it protects data but does not detect intruders.
• CI/CD: Software development and deployment processes.
• Threat modeling: Identifies potential threats before or during system design, rather than detecting successful infiltration.
• Data obfuscation: Makes information harder to understand, but is not an attacker-detection mechanism.

• HTTPS: Secure web traffic, not general command-line server administration.
• SNMPv3: Secure network monitoring and management, not interactive server login.
• RDP: Provides graphical remote desktop access. It can be secure, but it is not the direct replacement for Telnet in this scenario.
• SMTP: Used to send email.

• Custom domain: miami.weyland.com requires a paid App Service tier; Free and Shared are unsuitable.
• Two instances: Standard supports scaling to multiple instances.
• SSL: Standard includes SSL support.
• 12 GB storage: Basic provides only about 10 GB, so it does not meet the requirement. Standard provides substantially more storage.
• Cost minimization: Standard is the lowest tier among the choices that satisfies all requirements.

• Microservices: An application design approach that divides software into small services; it does not specifically reduce the number of operating systems.
• Containerization: Uses isolated containers that share the host OS kernel—best match.
• Virtualization: Creates separate virtual machines, and each typically requires its own guest OS, so it does not minimize OS instances as effectively.
• Infrastructure as code: Automates deployment and management of infrastructure; it does not describe the architecture being used.

• 10 minutes have elapsed, or
• 20 MB of accounting data has accumulated

Recommended process

1. Access each switch’s terminal.
2. Use help to identify available commands.
3. Use the MAC table command, such as:

text 
   show mac-address-table

1. Use VLAN information, such as:

text 
   show vlan

1. Use interface information, such as:

text 
   show ip interface brief

1. Record each device’s:

• Espionage: Stealing confidential information, often for a competitor or foreign entity.
• Data exfiltration: Unauthorized removal or transfer of data.
• Nation-state attack: A cyberattack sponsored or conducted by a government.
• Shadow IT: Unapproved technology or services used outside IT oversight.

• Unrestricted data mining: Data mining is not automatically a privacy violation. It becomes an issue when personal data is collected or used improperly.
• Identity theft: This is a possible consequence of inadequate privacy protection, but it is not the central focus of privacy regulations.
• Human rights protection: Privacy can be considered a human right, but this option is broader than the specific regulatory focus.
• Identifiable personal data: Regulations such as HIPAA focus directly on controlling the collection, use, disclosure, and protection of personal information.

• An Adj-SID does not necessarily need manual configuration.
• It can often be dynamically allocated by the router, although manual configuration may also be possible.
• The adjacency information is advertised through the IGP, such as IS-IS or OSPF.

• It is identified by an Adj-SID.
• It represents a particular adjacency of a node.
• Its meaning is generally local to the advertising node; unlike a Node-SID, it is not a globally reusable instruction across the network.

• Determine the project budget — Budget development is a separate cost-management activity.
• Develop a communication plan — This belongs to project communications planning, not schedule completion.
• Establish baselines — Baselines are created after the schedule and related plans have been developed and approved. They formally capture the approved plan.

• STIX: A standardized format for exchanging cyber-threat intelligence.
• OVAL: A language and framework for describing and assessing system vulnerabilities and configuration issues.
• Threat intelligence feed: Provides current indicators or threat information, but is not specifically a reference for common application exploitation techniques.
• CVE: A catalog of publicly disclosed vulnerabilities, identified by unique CVE numbers.

• Load balancer: Distributes application traffic; it does not protect switch MAC tables.
• IPS: May detect some attack traffic, but it is not the primary control for switch-port MAC learning.
• NGFW: Protects at network boundaries but does not directly limit MAC addresses learned on access ports.

• No servers or database infrastructure to provision.
• Uses standard SQL.
• Supports formats such as JSON, CSV, Parquet, and ORC.
• You typically define the table structure with AWS Glue Data Catalog or Athena’s own schema definitions.
• Charges are generally based on the amount of data scanned, so partitioning and columnar formats can reduce cost.
• It does not copy the data into a separate database; it reads the files in S3 when you run a query.

1. Append Table1 and Table2 as a new query

1. Select the product column in the appended query.

1. Choose Remove Rows > Remove Duplicates

1. It examines the source MAC address and learns it on the incoming port.
2. It examines the destination MAC address.
3. If the destination MAC is already in the MAC/CAM table, it forwards the frame only through the associated port.
4. If the destination MAC is unknown, it performs unknown-unicast flooding:

• B — Both inner and outer classes can be declared as with sharing.

• C — Inner classes do not inherit sharing settings from the container class.

apex 
public with sharing class OuterClass { 
    public with sharing class InnerClass { 
        // Explicitly uses sharing rules 
    } 
}

• Virtual introductions: Team members share their role, experience, location, and working preferences.
• Online icebreakers: Short, informal activities such as “two truths and a lie.”
• Virtual coffee chats: Pair team members for informal, non-project conversations.
• Collaborative problem-solving: The team works together on an online puzzle or scenario.
• Retrospectives: The team discusses what went well, what did not, and how to improve.
• Working-agreement sessions: The team agrees on response times, meeting etiquette, communication channels, and handoffs.
• Recognition sessions: Members acknowledge one another’s contributions.
• Remote workshops: Teams jointly create plans, diagrams, or schedules using collaboration tools.

• Namespace: The namespace associated with the code where the checkpoint was set.
• Time: When the checkpoint was captured or executed.

• Exception: Exceptions are viewed through debug logs or execution results, not as the primary Checkpoints tab information.
• Debug Statement: System.debug() output belongs in the Logs tab. A checkpoint captures program state, such as variables and their values, at a specific point in execution.

• /27 (255.255.255.224)

• /26 (255.255.255.192)

• /25: Creates only 2 subnets, not 3
• /28: Provides only 14 usable hosts per subnet

• Scale out during the hours when customer traffic is high.
• Scale in during low-demand periods, reducing instance-hours and cost.
• Use scaling policies based on metrics such as CPU utilization or request count.

• Multiple Availability Zones: Improves availability and fault tolerance, but does not automatically reduce cost.
• Placement group: Helps with specialized performance or low-latency requirements, not cost optimization.
• Private subnets: Improve network security, but do not automatically adjust capacity or reduce EC2 usage costs.

1. Yes — Microsoft Foundry provides a secure, governed environment for building and managing generative AI applications and agents. It brings together models, data, tools, evaluation, deployment, and monitoring.

1. Yes — Foundry is designed for enterprise workloads and supports scaling AI applications as usage grows. Scalability comes from the underlying Azure services and managed infrastructure.

1. Yes — Foundry can be used in solutions involving image recognition and computer vision. Applications can use vision-capable models and Azure AI vision capabilities for tasks such as image analysis, object detection, and OCR.

• 25 – Traditional SMTP server-to-server mail transfer; often blocked for client submission and not inherently secure.
• 110 – POP3 for receiving email; unencrypted by default.
• 143 – IMAP for accessing email; unencrypted by default.
• 587 – Authenticated email submission and commonly secured with TLS.

• Custom domains are supported.
• It provides dedicated compute instances.
• It offers enough storage for the applications.
• It supports multiple instances with load balancing between them.
• It is less expensive than higher tiers such as Premium.

• Free and Shared use shared compute and have limited storage, so they cannot meet the dedicated-instance requirement.
• Basic provides dedicated compute and custom domains, but the question’s requirement for the broader multi-instance/load-balancing capability is intended to point to Standard.

• An active relationship is used automatically when filters are evaluated. An inactive relationship does not propagate filters unless explicitly activated in DAX, so it would not reliably enforce the required security behavior.
• Apply security filter in both directions allows RLS filters to propagate across the relationship in both directions. This ensures that bidirectional filtering respects the RLS rules applied to both tables.
• Assume referential integrity is unrelated to RLS. It is mainly a DirectQuery optimization that allows Power BI to use an inner join when matching keys are guaranteed to exist.
• The relationship must therefore be active, with security filtering enabled in both directions.

• A — If there is no demand, there should be no production.

• B — Not all sales equal profit.

• C — Stocking up on inventory is bad for business.

• D — All costs, except materials, are considered fixed.

• E — Departments should operate at full capacity regardless of bottlenecks.

• Matching hashes: The software is likely unchanged.
• Different hashes: The software or its contents have been modified.

• Encryption: Protects confidentiality, not primarily integrity.
• Baselines: Document expected configurations and support comparison, but hashing is more directly suited to verifying file integrity.
• Tokenization: Replaces sensitive data with tokens and is unrelated to software tampering.

• MFA adds an additional authentication factor, such as a phone notification or verification code.
• It helps prevent unauthorized sign-ins, even if a password is compromised.
• It does not encrypt, store, or protect credentials used by deployment processes.

• A. Periodically rotate responsibilities: May reduce some risks, but it does not directly detect unauthorized changes.
• B. Review segregation-of-duties conflicts: Identifies incompatible access combinations, not whether a specific data change was unauthorized.
• C. Log changes in an outside application: Logs provide evidence, but someone must review and analyze them. Logging alone does not detect misuse.
• D. Independent review: Directly detects unauthorized changes and reduces the risk that the person making the change can conceal it.

• Accept: Acknowledge the risk and take no additional action.
• Transfer: Shift the risk or its financial impact to another party, such as through insurance or outsourcing.
• Mitigate: Reduce the likelihood or impact of the risk, such as by implementing security controls.
• Avoid: Eliminate the activity or exposure that creates the risk.

• Annual interest payments net of tax relief (A): future cash outflows for the issuer.
• Redemption value (B): the final cash outflow when the bond is redeemed.
• Market value now (C): the cash proceeds received now, acting as the initial cash flow in the IRR calculation.

• STP elects the switch with the lowest Bridge ID as the root bridge.
• The Bridge ID consists mainly of bridge priority + MAC address.
• If multiple switches have the same priority, the switch with the lower MAC address is preferred.
• STP bridge priority values are configured in increments of 4096, such as 0, 4096, 8192, and so on. 32768 is the standard default value.

• Root path cost
• Port priority
• Port ID

text 
interface GigabitEthernet0/1 
 spanning-tree vlan 10 port-priority 64

• Interface number: Helps form the port ID but is not normally configured as the preference value.
• VLAN priority: Not used to select a preferred forwarding interface.
• Hello time: Controls how often BPDUs are sent; it does not select a preferred port.

• SAS (Serial Attached SCSI):

• SSD (solid-state drive):

• Each Case must follow defined support steps.
• Each step must be completed within a specified time limit.

• Case Escalation Rules: Escalate Cases based mainly on age or criteria; they do not model a complete sequence of service steps.
• Process Builder with Scheduled Actions: Can automate time-based actions but is not the standard framework for Case service-level commitments.
• Omni-Channel Routing: Routes work to agents based on capacity and priority; it does not track Case lifecycle deadlines.