Batch record review skills matrix template

Overview

With our free batch record review skills matrix template, you will receive a clear overview of the skills that are present in your organization, as well as those that are missing. Using this information, you can develop and implement a plan to ensure that your employees’ skills are up to date, comprehensive, compliant, and ready for the future.

• Certified Batch Record Reviewer (CBRR)
• Certified Batch Record Specialist (CBRS)
• Certified Batch Record Compliance Specialist (CBRCS)
• Certified Batch Record Review Auditor (CBRRA)
• Certified Batch Record Trainer (CBRT)
• Certified Batch Record Compliance Analyst (CBRCA)
• Certified Batch Record Quality Assurance Manager (CBRQAM)
• Certified Batch Record Process Engineer (CBRPE)
• Certified Batch Record Review Consultant (CBRRC)
• Certified Batch Record Review Lead (CBRRL)
• Certified Batch Record Review Team Leader (CBRRTL)
• Certified Batch Record Review Auditor (CBRRA)
• Certified Batch Record Review Specialist (CBRRS)
• Certified Batch Record Review Project Manager (CBRRPM)
• Certified Batch Record Review Documentation Specialist (CBRRDS)
• Certified Batch Record Review Change Control Specialist (CBRRCCS)
• Certified Batch Record Review System Administrator (CBRRSA)
• Certified Batch Record Review Validation Engineer (CBRRVE)
• Certified Batch Record Review Regulatory Affairs Specialist (CBRRRAS)
• Certified Batch Record Review Performance Metrics Analyst (CBRRPMA)

Related skills

Batch Record Compliance: The skill of reviewing and ensuring compliance of batch records with regulatory requirements and internal procedures. While there is no specific certification solely dedicated to batch record review, certifications such as the Certified Quality Auditor (CQA) offered by ASQ demonstrate proficiency in audit techniques, regulatory compliance, and documentation review.

Good Documentation Practices (GDP): The skill of adhering to GDP principles during batch record review to maintain accuracy, completeness, and traceability of data. Certifications like the Certified Document Control Professional (CDCP) offered by the American Academy of Project Management (AAPM) validate expertise in documentation control, GDP, and document review.

GMP and Regulatory Knowledge: The skill of understanding Good Manufacturing Practices (GMP) and relevant regulatory requirements related to batch record review. Certifications such as the Certified Pharmaceutical GMP Professional (CPGP) offered by ASQ demonstrate proficiency in GMP principles, regulations, and their application in pharmaceutical manufacturing.

Quality Assurance and Compliance: The skill of ensuring batch records comply with quality standards and are in alignment with established quality assurance practices. Certifications like the Certified Quality Engineer (CQE) offered by ASQ validate expertise in quality management principles, process improvement, and quality assurance techniques.

Data Analysis and Troubleshooting: The skill of analyzing batch record data and identifying deviations, anomalies, or non-conformances. Certifications such as the Certified Six Sigma Green Belt (CSSGB) offered by ASQ demonstrate proficiency in data analysis, problem-solving methodologies, and process improvement techniques.

Benefits

Skills management software is important in batch record review as it allows organizations to track and manage the skills of personnel responsible for reviewing batch records, ensuring they possess the required expertise to perform accurate and thorough reviews, verifying compliance with specifications and regulatory requirements.