PDA 247.3 Fundamentals of Contamination Control, Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities
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This live eLearning training course is an invaluable compilation of knowledge, skills, validation and regulatory expectations for addressing compliant contamination control, incoming component contamination, cleaning, disinfection, validation and risk analysis for classified aseptic manufacturing facilities. This training course addresses Controlled Not Classified (CNC), Grade D, Grade C, and Grade A/B.
This training course will provide an industry professional the step-by-step plan of action to either develop a new contamination control program or evaluate a gap analysis model for an existing contamination control program.
- Control contamination ingress to facilities and within facilities
- Clean and disinfect facilities in a compliant and effective manner
- Validate cleaning agents and systems
- Describe regulatory expectations regarding cleaning and disinfection
- Determine appropriate cleaning agents, mechanisms, frequency and risk analysis to use
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Standard Pricing
Standard Member Price
$699GovernmentMember Only
$699
Health AuthorityMember Only
$699
Early Career ProfessionalMember Only
$699
StudentMember Only
$699
AcademicMember Only
$699
Non-Member
$699
Day 1
Section 1-5 (90 min)
- Basic Regulatory Expectations
- Full Circle Approach
- Controlling What Enters the Environment
- Cleaning the Environment
Break (15 min)
Section 6-9 (75 min)
- Testing the Environment
- Organisms
- Guidelines
- Destroying Viable Contamination
- Product Claims
Day 2
Section 10 (90 min)
- Validating Disinfectants (AET Studies)
Break (15 min)
Section 11-13 (75 min)
- Qualifying Vendors
- Sterilizing Disinfectants
- Clean Room Surfaces
Day 3
Section 14-15 (90 min)
- Resistance, Rotation, Built Immunity
- Resistance Studies
- Risk Analysis
Break (15 min)
Section 16 (60 min)
- Application of Disinfectants
Q&A (15 min)
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