Why Should You Attend?
Environmental Monitoring (EM) programs for pharmaceutical manufacturing are evolving to a risk-based approach. The use of sampling data for the identification and mitigation of risk becomes a critical element in this process. No longer is it enough to utilize data for reactive excursion reporting.
Areas Covered in the Webinar
This presentation will discuss how to establish a risk-based Environmental Monitoring Program. During this session we will discuss how to set up a new Environmental Monitoring Program based on risk as well as how to perform a reassessment of your current Environmental Monitoring Program to re-establish sampling locations and frequencies based on results of your risk assessments coupled with the knowledge gained from your current EM Program historical data.
Key Learning Objectives of your Topic:
- Current regulatory requirements for environmental monitoring
- How to select sample locations based on risk
- How to perform a risk assessment to support your EM Program
- Differences in room classifications and impact to your EM Program
- Monitoring methods, equipment and media types
- Data collection, microbial identifications and data trending options
Industries That Can Attend
This 60-minute online course is intended for professionals in the Medical Device, Biotechnology, Pharmaceutical Industry. Although not presently stated in the draft, the same guide could be used by FDA Regulated Industries personnel.
- Q/A Session with the Expert to ask your question
- PDF print only copy of PowerPoint slides
- Certificate of attendance
ASA Training and Quality Consulting LLC
Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems. Prior to this role, Ms. DeLucy has been in the industry for 15 years serving in numerous quality management roles, such as the director of product quality, the oversight of sterility assurance practices and provided QA oversight of numerous filling and packaging operations.
Ms. DeLucy began her QA career as a quality control pharmaceutical microbiologist at Lancaster Laboratories, a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the quality management arena while increasing her responsibility. She has helped lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, she assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.