Pharmaceutical gases such as Compressed, Nitrogen Argon gas systems used for the production of finished pharmaceutical or other types of products may either have direct or indirect impact to the finished products. These gases are also used for other medical and non-routine processes hence understanding the design, validation, routine monitoring, data management, failure investigations, regulations and applicability of each type of gas system ensures compliance to the required regulations. A detailed technical understanding of how to perform these critical steps during the initial evaluation or re-evaluation of a new, modified or existing gas system will eliminate expensive failure or remediation issues, inability to perform validation as well as routine testing and maintenance issues which ultimately impact or delay the release of the affected product.
This 2 days seminar will provide the attendee an extensive technical and practical knowledge that includes the step by step process of evaluating a new gas system through the design, installation, validation, routine monitoring/testing, data management, performing a gas failure investigation, excursion or out of specification results and trending so as to avoid the high cost associated with a poorly designed system. This seminar contains a lot of technical content, case studies, practical discussions and an exciting learning environment.
Why you should attend:
This seminar will provide an enormous amount of technical information and will be beneficial to those involved in the establishment, design, installation, validating, testing, review and approval of a new and modified or existing pharmaceutical gas programs so as to meet the requirements of ISO 8573, USP or FDA requirements. It will also benefit the vendors and suppliers of pharmaceutical gases to ensure compliance to the different regulatory bodies’ requirements.
Learning Objectives:
Upon completion of this seminar, the attendees will be able to:
- List the applicable regulations and how it applies to the different types of gases.
- Plan, define, design, re-design, appropriately install, validate, routinely test and remediate a gas system to avoid future failure and to achieve compliance to regulations.
- Define and design a robust Analytical and Microbiological testing program for pharmaceutical gases with each defined specific assay required for each type of gas system.
- Design a robust pharmaceutical gas testing trending program and defining the alert and action levels for each test methodology to ensure a state of control for the gas systems.
- Perform analytical and microbiological gas testing data review and management and utilizing the data for gas testing trend reports.
- Perform Out-of-specification, Alert and Action Levels Excursion, Contamination or Failure Result investigation and Remediation of routine gas testing program.
Who will Benefit:
This seminar will benefit those involved in manufacturing, using, testing and Validating pharmaceutical gas systems in various industries such as the Pharmaceutical, Biotechnology, Drug, Biologics, Medical Device and In-vitro Diagnostics Product Manufacturing Industries, especially:
- 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 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
- 08.30 AM - 09.00 AM: Registration
- 09.00 AM: Session Start
- Regulations Guiding Pharmaceutical Gases
- How to Choose a Specific Gas System
- Argon Gas-Use and Applications
- Compressed - Use and Applications
- Nitrogen Gas - Use and Applications
- Evaluating the Needs Prior to Choosing a Design
- What to look for during this evaluation phase.
- Needs versus Compliance Based Approach.
- Understanding your product type.
- Understanding your capabilities
- Understanding your products or processes.
- Understanding the impact to other operations and infrastructure.
- Cost versus Benefits
- Evaluating the Supplier or Vendor
- Making the right choice
- What to look for when choosing a pharmaceutical gas supplier or vendor.
- Quality and Compliance, Customer Service or Both.
- Supplier’s Role in the Evaluation Process
- 10:00am-10:15am (Break)
- 10:15am–11:00am
- The Initial Design Planning Phase
- Who to include when planning a pharmaceutical gas system
- Impacted departments
- Impacted operations
- Impacted Operations and Processes
- Involving the Impacted Department.
- Involving the Quality Organization and Testing Operations
- Seeking Feedback from Stakeholders
- Weigh the Pros and Cons
- Gather Ideas
- Placing Ideas on Paper and Design Drawing
- Comparing Design with other Possible Impacted or Related Systems
- 11:00am-12:00pm
Choosing the Gas System Type and Design- Using ideas and decisions to design the gas system.
- Verifying functionality/how to determine a good design
- Compare design with validation plans
- Compare gas design with current infrastructure to determine impact
- Address all possible impact.
- Involve Facilities and Engineering
- Put design on paper and evaluate feasibility of design with the planned validation and routine testing
- 12:00pm-1:00pm (Lunch)
- 1:00pm–2:00pm
Validating Pharmaceutical Gases- Planning the Gas System Validation
- Designing the Gas System Validation Protocol to meet regulations.
- What to include in a robust pharmaceutical gas system validation protocol
- Deciding on what use points, number of testing days and types of test to perform.
- Setting the test specification or acceptance criteria (action levels)
- Reviewing and approving the protocol.
- Who should review and approve the validation protocol.
- 2:00pm–3:00pm
Validating Pharmaceutical Gases contd.- Designing a Pharmaceutical Gas System Report
- What to include in the Pharmaceutical gas system validation report.
- Data management of Pharmaceutical gas system validation result.
- Translating the Pharmaceutical gas validation data into routine monitoring of the gases.
- Handling out of specifications or deviations during the validation.
- Approving the validation report.
- 3:00pm-3:15pm (Break)
- 3:15pm-4:00pm
Drafting Associated Standard Operating Procedures or Standard Test Methods- SOPs or STMs must be approved prior to routine monitoring and testing.
- 4:00pm – 5:00pm
Case Studies and Questions/Answers
- 9:00am–10:00am
Routine Testing Programs for Pharmaceutical Gases- Designing a Routine Pharmaceutical Gas Testing Program
- How to Transition from the Validation Phase into Routine Monitoring of Gases
- Understanding what to include in the routine gas testing program
- Types of pharmaceutical gas testing programs
- Defining Pharmaceutical Gas Testing Frequencies and Specifications
- Microbiological Monitoring and Testing Programs for Pharmaceutical Gases
- Designing a Viable Airborne Testing Program for Pharmaceutical Gases
- Performing the Sampling and Testing
- Documenting the Results of Viable Airborne Particulate Testing
- Interpreting the Results of Viable Airborne Particulate Testing
- Designing a Non-viable Airborne Particulate Testing Program for Pharmaceutical Gases
- Designing a Viable Airborne Testing Program for Pharmaceutical Gases
- 10:00am-10:15am (Break)
- 10:15am–11:00am
Analytical Monitoring and Testing Program for Pharmaceutical Gases- Designing an effective Analytical Testing Program for Pharmaceutical Gases
- Types of Testing to Include for Analytical Testing Program
- Dew Point Evaluation
- Hydrocarbon Evaluation
- Moisture Evaluation
- Oxygen Evaluation
- Considerations during the various types of testing
Best Practices to consider when testing pharmaceutical gases.
- Aseptic techniques
- Appropriate gowning practices
- Sampling materials
- Disinfection practices
- Outlets and locations
- Avoiding Common Mistakes
- 11:00am–12:00pm
Pharmaceutical Gas Failure and Contamination- Types of Failures
- Out-of-specification Investigation (Alert and Action Levels Excursions)
- Contamination
- Types of Contaminants
- Microbial
- Water or Vapor
- Other Gases
- Cross Contamination
- Chemical
- Oil
- Types of Contaminants
- Investigating a Pharmaceutical Gas Testing Failure or Contamination
- How to initiate a pharmaceutical gas system failure investigation
- What to include in a pharmaceutical gas system failure investigation
- What to verify, evaluate and eliminate during the investigation
- How to document the pharmaceutical gas system failure investigation
- How to Disposition the Impacted Batch or Product Affected by pharmaceutical gas testing failure.
- Common mistakes made during a pharmaceutical gas testing failure investigation
- 12:00pm-1:00pm (Lunch)
- 1:00pm-2:00pm
Remediation of Pharmaceutical Gas System Failures- Performing the remediation activities
- Return to use processes and testing activities.
- Routine Preventative Maintenance Programs
- Effectively using test data derived from Pharmaceutical Gas Testing Program
- Data management of Pharmaceutical Gas Testing Program
- Trending of Pharmaceutical Gas Testing Data- Applying the Results
- Routine Testing of Pharmaceutical Gas Systems –Post-validation Testing
2:00pm-3:00pm
- 3:00pm-4:00pm
Review of Case Studies- FDA Recent Form 483 Applicable to Pharmaceutical Gases- Case Study #1 – FDA Form 483 Associated with Pharmaceutical Gas Systems
- Case Study #2 - FDA Form 483 Associated with Pharmaceutical Gas Systems
- Case Study #3 - FDA Form 483 Associated with Pharmaceutical Gas Systems
- How to Address Compliance Issues
- Compliance Implications
- Impact to Product/Batch
- Production Costs
- Impact to the Production Process
- 4:00pm – 5:00pm
Question and Answer Session
Charity Ogunsanya,
CEO and Founder, Pharmabiodevice Consulting LLC
Charity Ogunsanya, is the CEO and founder of Pharmabiodevice Consulting LLC. Ms. Ogunsanya has over 23 years of extensive practical and management experience in various Fortune 100 pharmaceutical, biotechnology, biologics, cell therapy, diagnostics, research and development, radio-pharmaceutical, Contract Manufacturing Organization (CMO) and medical device/IVD companies.
She has been a much sought after SME to assume key roles specifically related to remediation and difficult quality and compliance related deficiencies associated with FDA’s Consent Decree, FDA’s Warning Letters and other regulatory bodies’ inspectional findings. Her remediation work has constantly resulted in several successful national and international regulatory bodies’ inspections, re-inspections and new product approvals.
Her technical expertise covers and goes beyond interpretation, administration and set up of quality assurance, quality/compliance, quality engineering, aseptic processing, contamination control, quality control, microbiology, sterility assurance, stability, vaccine development, new product design, product release testing and medical device sterilization (ethylene oxide (EtO), gamma, radiation, VHP sterilization) systems and operations for compliance to various regulations.
She has a keen working knowledge of the requirements and regulations guiding new and existing products from planning through design, proof of concept, research and development, technology transfer, pre-clinical, clinical, commercial manufacturing, supply chain, regulatory filings, pre-approval inspections, licensure, government affairs, commercialization and post-approval inspections.
She is a member of the Parenteral Drug Association (PDA), American Society of Microbiologists (ASM), and other Scientific Forums and Industry Expert Network. She has a Bachelor of Science degree in Microbiology from the University of Benin-Nigeria and she is currently attaining her Masters in Biotechnology (Biodefense Concentration) at the Johns Hopkins University Advanced Academic Program.
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