Many life sciences teams struggle with:
Overlooking microbial risks until contamination events occur
Weak oversight of utilities and manufacturing environments
Incomplete sampling plans and ineffective monitoring programs
Explaining prevention costs to senior management teams
Managing CDMO and laboratory responsibilities with clarity
Participants learn a structured, practical approach including:
Building preventive microbial control across end-to-end operations
Identifying hazards in materials, people, utilities, environments
Designing monitoring plans with useful trending data
Applying FDA and USP expectations with confidence
Strengthening oversight of outsourced manufacturing partners
This course gives professionals a practical framework to prevent contamination, improve compliance, and make better risk-based decisions across non-sterile manufacturing.
Many life sciences teams struggle with:
Overlooking microbial risks until contamination events occur
Weak oversight of utilities and manufacturing environments
Incomplete sampling plans and ineffective monitoring programs
Explaining prevention costs to senior management teams
Managing CDMO and laboratory responsibilities with clarity
Participants learn a structured, practical approach including:
Building preventive microbial control across end-to-end operations
Identifying hazards in materials, people, utilities, environments
Designing monitoring plans with useful trending data
Applying FDA and USP expectations with confidence
Strengthening oversight of outsourced manufacturing partners
This course gives professionals a practical framework to prevent contamination, improve compliance, and make better risk-based decisions across non-sterile manufacturing.
Understand core risks in non-sterile pharmaceutical manufacturing
Compare prevention-focused systems with reactive investigations
Build a defendable microbial control strategy framework
Design effective environmental monitoring and sampling programs
Improve microbial limits testing interpretation and follow-up
Use trending data to support quality decisions
Evaluate microbial risks in materials and components
Strengthen purified water and process water system control
Apply cleaning and disinfection best practices effectively
Interpret FDA draft guidance for non-sterile drugs
Understand evolving USP <1111> expectations and relevance
Manage CDMO and outsourced laboratory oversight risks
Understand core risks in non-sterile pharmaceutical manufacturing
Compare prevention-focused systems with reactive investigations
Build a defendable microbial control strategy framework
Design effective environmental monitoring and sampling programs
Improve microbial limits testing interpretation and follow-up
Use trending data to support quality decisions
Evaluate microbial risks in materials and components
Strengthen purified water and process water system control
Apply cleaning and disinfection best practices effectively
Interpret FDA draft guidance for non-sterile drugs
Understand evolving USP <1111> expectations and relevance
Manage CDMO and outsourced laboratory oversight risks
Learn to strengthen microbial control systems, investigations, and compliance oversight for non-sterile operations
Improve sampling, testing, trending, and interpretation of microbiological results with greater confidence.
Better control utilities, environments, and manufacturing conditions that influence microbial risk.
Apply regulatory expectations and improve oversight of outsourced manufacturing and testing partners.
Learn to strengthen microbial control systems, investigations, and compliance oversight for non-sterile operations.
Improve sampling, testing, trending, and interpretation of microbiological results with greater confidence.
Better control utilities, environments, and manufacturing conditions that influence microbial risk.
Apply regulatory expectations and improve oversight of outsourced manufacturing and testing partners.
Karen Taylor is a highly respected GMP and quality systems consultant with more than 30 years of industry experience supporting global pharma and biotech companies in inspection readiness, regulatory strategy, computerized systems compliance, and data governance. She is also an award-winning international speaker known for translating complex GMP changes into practical, real-world guidance.
Areas of expertise: • GMP • Quality Systems • Inspection Readiness • Computerised Systems • Data Governance • Regulatory Strategy • CMO Audits
More than 30 years in pharma and biotech consulting
Supported startups and global companies through inspections
Co-founded PDA interest group on outsourced operations
Multiple speaker of the year award recipient
Karen Taylor is a highly respected GMP and quality systems consultant with more than 30 years of industry experience supporting global pharma and biotech companies in inspection readiness, regulatory strategy, computerized systems compliance, and data governance. She is also an award-winning international speaker known for translating complex GMP changes into practical, real-world guidance.
Areas of expertise: • GMP • Quality Systems Inspection • Readiness • Computerised Systems • Data Governance • Regulatory Strategy • CMO Audits
More than 30 years in pharma and biotech consulting
Supported startups and global companies through inspections
Co-founded PDA interest group on outsourced operations
Multiple speaker of the year award recipient
Interactive sessions with real-time Q&A and expert guidance
Two intensive sessions: 10:00-13:30 EST each day
4 live sessions of 3 hours each
Review sessions and reference materials at your own pace
No. The course is designed for both microbiologists and professionals without formal microbiology training. It explains the science in a practical way that supports quality, operations, regulatory, and oversight roles.
It is primarily designed for professionals involved in non-sterile pharmaceutical manufacturing and related support functions. It is also highly relevant for teams overseeing outsourced operations, water systems, environmental monitoring, and microbial quality controls.
Yes. The course includes FDA’s draft guidance related to microbiology for non-sterile drugs and explains how these expectations affect manufacturing, quality systems, and compliance decisions. It also addresses evolving pharmacopeial expectations such as USP <1111>.
Yes. The training is built to support global compliance thinking and includes perspectives relevant to FDA, EMA, and modern GMP expectations. It is especially useful for teams operating across multiple sites or markets.
