Current Trending Topics in Animal Health and Veterinary Products

• Review of regulatory requirements for veterinary medical devices
• Emerging technology in veterinary medicine
• Best practices for compliant study conduct at very small CROs

Current Trending Topics in Bioanalysis:

• Regulatory strategy for Covid-19 related to bioanalytical facilities and data. FDA Remote Records Reviews (RRR), experience and results so far, future plans
• Bioanalytical e-data: human readable formats, audit trail review, expectations for data flow diagrams, audit strategies for e-data
• Emerging technology in bioanalytical: managing risk and onboarding new technologies

Current Trending Topics in Beyond Compliance:

• Challenges of building and sustaining a quality culture across disciplines
• Risk-based CAPA prioritization driven by criticality of observation
• Trending analysis for key performance indicators
• Hybrid and remote auditing practices
• Building productive QA-operations partnerships, engagement, and trust-building
• Career pathways in quality and compliance
• Navigating organizational politics while maintaining integrity
• Providing future development to leaders
• Ethical considerations of emerging technologies
• Knowledge Management and retention
• Competency-based training design
• Knowledge transfer between generations
• Training for critical thinking and problem solving
• Cross-functional training

Current Trending Topics in Computer Validation:

• Cloud
• Disaster recovery and business continuity
• SDLC, including release notes assessments.
• Artificial Intelligence/Machine Learning
• Qualification of development tools (i.e. GitHub, JIRA, etc.)
• Backup and Retention
• Electronic Archive
• Database predictive algorithms (continuous updates)
• Risk
• System Implementation
• Audits
• CSA-Computer Software Assurance

Current Trending Topics in GLP:

• Emerging technologies
• OECD Guidance Document on Good In Vitro Method Practices (GIVIMP)
• Clinical analyses conducted in a GLP facility
• Differences between EPA and FDA GLPs (e.g., differences in inspections)
• Differences between EPA TSCA and EPA FIFRA
• Global submissions delayed in other countries due to requirement for certified laboratories
• EPA status of TSCA GLPs, Update on TSCA regulatory inspection observations
• FDA GLP update, what is status, what are proposed changes
• Various OECD topics
• Quality Risk Management

Current Trending Topics in GMP:

• Emergency Use Authorization
• Good Distribution Practices
• Unique needs/considerations for manufacturing cell/gene therapy products

Current Trending Topics in Histopathology

• Training across multiple countries, if trainer is in a different country than the pathologist, shipping slides with CoC
• Compliance crossing country borders, e.g. with pathologists in a different country than the testing facility
• Recent regulatory guidance
• Validation for systems, especially digital pathology
• Emerging issues with AI and Machine Learning, including use by human doctors for pathology diagnosis
• Archival for electronic systems 
• How to give computer system access to FDA Investigators (including consideration to the IOM update they now will request access, how much, how long)

Current Trending Topics in Medical Devices:

• QA audit & Regulatory overview for Medical Device GLP study
• Data Integrity
• Training for TFM (IT Management, Environmental Management, Animal Care) in GLP Studies in a University 
• Data Governance Challenges in the University Setting
• Imaging and Use of devices (for data capture) intended of Human use in a University Setting
• GLP Archiving at the University (paper and digital)

Current Trending Topics in Pharmacovigilance:

• Risk Based Approaches (RBA) for Audit Preparation, Conduct and Reporting: Going beyond the use of risk-based approaches for audit planning to focus on the practical aspects of audit conduct (e.g., data analytics, audit scoping, sampling, and the tools used to perform these tasks). How can RBA be utilized to ensure we are auditing the critical PV topics that are the highest risk areas (i.e., those that are the subject of critical/major findings in health authority inspections)?
• Selecting the Best Database for Your Pharmacovigilance System: What options are available across the industry for safety databases and what are the trends across small, mid-sized, and large companies? What is the impact of a company’s product line (e.g., vaccines, combination products), global presence, and commercial status on database selection?
• Transitioning from Clinical Trial Safety to Post Marketing Pharmacovigilance: What are the similarities and differences between the two activities? How can GCP-focused auditors build upon this knowledge to support GVP audits?

Current Trending Topics in the University Specialty Section:

• Data Integrity
• Test Facility Management (IT Management, Environmental Management, Animal Care) Training for GLP studies
• Data Governance Challenges in the University Setting
• GLP Archiving at the University (paper and digital)
• Animal care in a university setting

Current Trending Topics in Quality Assurance Consulting:

• Transition from employee to employer (even if you are only employing yourself)
• How to guide (or consultant friends guide from how to become independent to getting your first contract)
• How to fire a customer (or maybe better yet... when to cut bait).
• Contracts, the ins-and-outs
• Cybersecurity and Cyber Insurance Considerations for Contractors / Small Businesses
• Remote Audit Considerations for Consultants and Clients (a panel discussion about things such as saving travel time, but requiring more agenda planning time, timing of document reviews and personnel interviews, more time required for navigating/revising documents remotely, facility tour options, etc.)
• TMF Inspection Readiness
• How to "add" an employee to your business (or to just one project)
• How to renegotiate contracts
• Process Implementation - embedding a quality culture in execution