Sterilization Professionals Certification Program - Bundle Pack

Sterilization Professionals Certification Includes the below courses:

Training#1 Sterilization of Pharmaceutical Products and Medical Devices (1 hrs)

Training#2 Steam Sterilization Microbiology and Autoclave Performance Qualification ( 1hr)

Training#3 Aseptic Processing and Validation ( 3hrs)

Training#4 Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products (6hrs)

Training#5 4-Hour Virtual Seminar on Aseptic Technique and Cleanroom Behaviours – Avoiding Human Error

Training#1 Sterilization of Pharmaceutical Products and Medical Devices (1 hrs)

Webinar Takeaway

• Sterile filtration - Importance of Quality
• Sterility Assurance of Sterile Filtration
• Sterile Filtration System Design
• Discussion of Different Filtration Media Properties and Retention Mechanisms
• Methods for Sterilization of Filters
• Validation of Sterile Filter Systems
• Microbial Retention Challenge Testing
• Integrity Testing
• Product Compatibility Testing
• Extractable/Leachable Testing
• Regulatory Requirements

Training#2 Steam Sterilization Microbiology and Autoclave Performance Qualification ( 1hr)

Webinar Takeaway

• Definitions.
• IQ/OQ/PQ Requirements for Autoclave Validation
• Autoclave Monitoring Tests
• Biological Indicators - How and When to Use
• Verification vs. Revalidation

Learning Objectives:

• Steam sterilization on a microbial level
• Autoclave Performance Qualification expectations
• Regulatory and GMP requirements for steam sterilization
• Process verification tools for use in an autoclave
• Common questions, problems and cGMPs

Training#3 Aseptic Processing and Validation ( 3hrs)

Why should you attend

Course Objectives: At the completion of this course, attendees will be able to:

• Explain the difference between Aseptic and Bulk processing
• Understand facility and personnel requirements necessary to maintain microbial control
• Explain basic principles of microbiology and microorganism recovery in relation to cleanroom environmental monitoring (EM) and impact to product
• Understand the gowning requirements associated with different cleanroom classifications
• Explain basic principles of aseptic processing, including:
• Cleanliness classifications
• Proper Engineering controls
• Process differences between aseptically produced and terminally sterilized product
• Relation of manufacturing and handling procedures to sources of product contamination
• The differences between cleaning, disinfection and sanitization
• Proper cleaning / disinfectant technique
• Elements of a robust environmental program and why EM is important
• The purpose of media fills, and elements critical to their success
• The role of isolator technology
• Identify behaviors that are or are not appropriate when working in controlled areas, and why
• Identify ways that they can impact/improve site-specific EM and aseptic behavior issues

Training#4 Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products (6hrs)

Aseptic Processing – Introduction

• ·      The Disinfected Quantity Form
• ·      Conservation and control of serious surroundings
• ·      Expansion of procedures for process, standardization, Preventive Maintenance, CAPA, etc.
• ·      Exercise of workers to include gowning
• ·      Certification and assessment of variations
• ·      Adulteration Sources in Sterile Manufacturing
• ·      Subdivision Content Controls
• ·      Cross Pollution Hazards
• ·      Cleaning Process and Agents for Sterile Production

Developing Media Fill Requirements in An Aseptic Environment

• ·      Form FDA 483s
• ·      Equipment set up
• ·      Sterilization process
• ·      Media fills
• ·      Smoke studies and their emphasis in Aseptic Production (ISO Class 5 facilities)
• ·      Endotoxin sources

Training#5 4-Hour Virtual Seminar on Aseptic Technique and Cleanroom Behaviours – Avoiding Human Error

Training Agenda

Module 1: Basic Micro Review

• The role of environmental monitoring

• Types & sources of microorganisms

• The impact of microorganisms on product and patient health and safety

Module 2: Review Aseptic Processing Basics

• Cleanliness classifications

• Process differences between aseptically produced and terminally sterilized product

• Relation of manufacturing and handling procedures to sources of product contamination

• The differences between and the purposes of cleaning, disinfection and sanitization

• Proper cleaning techniques

• The role of isolator technology 

Module 3: Review Clean Area Behaviours

• Personnel gowning requirements

• Good clean area behaviors/practices

• Practices to avoid – and why

• Review site-specific EM/aseptic behavior observations/risks & ask attendees to brainstorm ways to change/improve/eliminate these behaviors & risks

Module 4: Aseptic Validation

• The purpose of media fills, and elements critical to their success

Who Will Benefit

The Sterilization Professional Certification will be valuable to all individuals working within or managing sterilization and Sterility Assurance processes that supports sterile products requiring sterilization prior to release for use.

Obtaining the Sterilization Professional Certification would be beneficial to professionals in various industries such as the Pharmaceutical, Biotechnology, Drug, Biologics, Medical Device and In-vitro Diagnostics Product Manufacturing Industries, especially those within the following departments:

• Sterilization Engineers and Specialists
• Sterility Assurance Personnel
• Auditors and Quality Assurance Supplier Auditors
• Quality Assurance Personnel and Management
• Quality Control Personnel and Management
• Laboratory Managers
• Testing Analysts and Technicians
• Manufacturing Personnel and Management
• Suppliers and Vendors of Pharmaceutical Gas Systems
• Validation Personnel and Management
• Supplier Quality Assurance Auditors, Personnel and Management
• Regulatory Affairs Personnel and Management
• Shipping and Receiving Personnel and Management
• Facility and Maintenance Personnel and Management
• Microbiologist Personnel and Management
• Engineering Personnel and Management
• Materials Management Personnel and Management

Upon completion of this Certification, you will be able to:

• Interpret the various Sterilization and Sterility Assurance regulations, standards and requirements
• Apply regulatory requirements to routine operational sterilization and sterility assurance applications
• Plan and manage sterilization process controls to minimize product non-conformances and product sterility failures and investigations
• Train and mentor internal sterilization, manufacturing, sterility assurance and other critical staff on various types of sterilization process requirements including the qualification and requalification requirement
• Develop various types of Sterilization and Sterility Assurance Process Standard Operating Procedures (SOPs)
• Prepare and Execute IQ, OQ and PQ protocols and draft reports for various sterilization processes and systems
• Perform effective technical audits of Sterilization Process Suppliers and Vendors using key audit review requirements applicable to sterilization and cleanroom controls
• Represent an organization as a Sterilization and Sterility Assurance Subject Matter Expert (SME) during FDA and other International Regulatory bodies’ inspections
• Interact with management, regulators and other external auditors.