MR Regulatory Framework and Compliance 3 — Questions and Answers
Question 1: Which FDA guidance document outlines the agency's current thinking on process validation for pharmaceutical manufacturing?
- FDA Guidance on Q10 Pharmaceutical Quality System
- FDA Process Validation Guidance (January 2011) (Correct answer)
- ICH Q8 Pharmaceutical Development
- 21 CFR Part 211 Subpart F
Correct answer: FDA Process Validation Guidance (January 2011)
The January 2011 FDA Process Validation Guidance introduced the three-stage lifecycle approach: process design, process qualification, and continued process verification.
Question 2: Under the EU MDR, Class III medical devices require which type of conformity assessment?
- Self-declaration by the manufacturer
- Technical file review by a Notified Body
- Full quality assurance system assessment and design examination by a Notified Body (Correct answer)
- Only a performance evaluation report
Correct answer: Full quality assurance system assessment and design examination by a Notified Body
Class III devices pose the highest risk and require Notified Body involvement in both the quality management system audit and design dossier examination.
Question 3: What is the purpose of a Regulatory Strategy document prepared by the Management Representative?
- To replace the need for a Technical File
- To outline the regulatory pathway, timelines, and resource requirements for market authorization (Correct answer)
- To document the results of post-market surveillance studies
- To serve as the basis for supplier qualification audits
Correct answer: To outline the regulatory pathway, timelines, and resource requirements for market authorization
A regulatory strategy document maps the chosen approval pathway, expected agency interactions, milestones, and resources needed to achieve market authorization.
Question 4: Under 21 CFR Part 11, which combination of controls is required for electronic records used to meet FDA requirements?
- Encryption and biometric authentication only
- System validation, audit trails, and appropriate controls for electronic signatures (Correct answer)
- Password protection and daily backups
- Printed paper copies and electronic duplicates
Correct answer: System validation, audit trails, and appropriate controls for electronic signatures
Part 11 requires validated systems, audit trails capturing who made changes and when, and electronic signatures that are equivalent to handwritten signatures.
Question 5: A Management Representative is preparing for an ISO 13485 surveillance audit. Which action is most important before the audit?
- Temporarily suspend all nonconforming product procedures
- Conduct an internal audit and management review to identify and close gaps (Correct answer)
- Limit auditor access to only recently updated procedures
- Reassign all CAPAs to 'closed' status
Correct answer: Conduct an internal audit and management review to identify and close gaps
Performing an internal audit and management review ensures genuine readiness by identifying real gaps that can be addressed before the external auditor arrives.
Question 6: Which regulatory body oversees the Medical Device Single Audit Program (MDSAP)?
- FDA alone
- A consortium including FDA, Health Canada, TGA, ANVISA, and PMDA (Correct answer)
- The European Commission
- ISO Technical Committee 210
Correct answer: A consortium including FDA, Health Canada, TGA, ANVISA, and PMDA
MDSAP is a collaborative program among five regulatory authorities — FDA, Health Canada, TGA (Australia), ANVISA (Brazil), and PMDA (Japan) — allowing a single audit to satisfy multiple country requirements.
Question 7: Under HIPAA, what is the minimum necessary standard as it applies to a healthcare compliance function?
- Using the minimum number of staff to handle protected health information
- Accessing only the minimum amount of PHI needed to accomplish the intended purpose (Correct answer)
- Retaining PHI for the minimum legally required period
- Applying the minimum encryption standard to stored PHI
Correct answer: Accessing only the minimum amount of PHI needed to accomplish the intended purpose
The minimum necessary standard requires covered entities and business associates to limit PHI access to what is reasonably needed for a given task or disclosure.
MR Regulatory Framework and Compliance 3
Which FDA guidance document outlines the agency's current thinking on process validation for pharmaceutical manufacturing?