3rd Annual HPAPIs: Containment & Handling Summit 2023

CONFERENCE OVERVIEW

Highly potent active pharmaceutical ingredients, or HPAPIs, are potent compounds that could effectively treat serious and life-threatening diseases such as cancer. Because of their high potency, these substances eventually put the workers in the production facility at risk. While exceptional product quality is required, additional measures must be taken to ensure operator safety.

At our online meeting, leading figures from the industry, occupational toxicologists and containment specialists will review the most recent developments affecting the handling of HPAPIs. The discussion will center on the safe and effective processing of potent APIs, process development and scale-up, occupational health hazards, toxicological assessment, improvements in isolators and facilities to minimize exposure risk, containment and cleaning validation practices, and risk management for cross-contamination.

In the end, managing HPAPI safely and effectively necessitates a thorough evaluation of a number of factors. This September, keep a look out for any new developments in HPAPI production and processing.

WE WILL TALK ABOUT

• Verification and monitoring of containment performance.
• Achieving containment performance targets in practice - a five year review of air sampling data.
• In this presentation, you will learn more about risk-based approach throughout hpapi manufacturing to ensure occupational safety.
• Quantitative measurement of risk in cleaning using ASTM standards.
• Cleaning process development for HPAPIs and final dosage forms.
• Lessons learnt from cross contamination/gradient study across pharmaceutical formulation sites.
• Managing HPAPI risks using a relational risk analysis approach.
• Lessons learnt from containment validation globally.
• Implementation of complaint and regulatory observation proven cleaning validation program at potent compound contract facilities.
• Exposure limits and bands for HPAPIs and the importance of a qualified expert.
• How to optimize the manufacturing of OEB4 APIs and intermediates: SEQENS value proposition for the oncology market.
• Human factors supporting human performance.
• Garment selection criteria for the safe handling of HPAPI.
• Achieving industrial hygiene standards of care in pharmaceutical R&D and manufacturing.
• Considerations for optimizing a multi-product, shared facility for HPAPI OSD products.
• HPAPIs and their unique challenges.
• Development of lab/pilot scale continuous separation technologies for high potent API processing.
• Risk assessments in potent HPAPI projects.

WHO IS IT FOR?

CxO, VPs, Directors, Heads, Managers of

• HPAPI Manufacturing/ API Manufacturing/ Compounds Manufacturing
• Occupational Toxicology/ Industrial Hygiene / EHS
• Process Engineering/ Process Development/ Process Scale Up
• Containment/ Cross Contamination/ Cleaning Validation
• Cleanroom/ Facility Design/ Isolators
• Risk Management/ Quality Assurance/ Quality Control
• Analytical Development/ Analytical Methods
• CMO/ CDMO/ Outsourcing

[Agenda] 3rd Annual HPAPIs: Containment & Handling Summit 2023

Download the full summit program to find speaker biographies, case studies, key takeaways, the day's schedule, and details of each session.