SAE Media Group’s 5th Annual Conference
Pharmaceutical Microbiology East Coast
April 27-28 2022 | Boston, US
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Microbiology remains an essential tool in reducing microbial growth in the manufacture of pharmaceuticals, to detect and eliminate microorganisms that would pose a risk to patients and jeopardise product batches.
Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however an array of factors are also sustaining new growth and transformation in this field. The regulatory landscape is changing, firstly with the preparation of Annex I, in addition to increasing requirements pertaining to data integrity. Light is being shed on recent product recalls for mould contamination, and infection outbreaks serve as a reminder to pay more attention to these overlooked organisms, as well as considerations towards container closure integrity testing which is being increasingly deployed to block microbe movement.
Cleaning procedure and validation are essential components of the pharmaceutical manufacturing process that prevent cross contamination and issues with compliance – ultimately protecting the safety of patients. In this workshop we will walk through robust risk-based approaches to cleaning monitoring, and Continued Process Verification.
This workshop will address the following topics:
- Quick review of regulatory guidelines for maintaining the validated state
- Legacy cleaning validation concerns and pitfalls
- Explore the benefits for re-validating legacy cleaning processes
- Tour and examine the re-validation process
FEATURED SPEAKERS
Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk
Fred Ohsiek is the Sr Cleaning Validation Specialist for Novo Nordisk in Clayton, NC. He earned his Bachelor in Chemistry from University of South Florida. His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 20 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Ben Venue Laboratories, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk.
His cleaning validation experience includes risk assessments, cleaning development, validation, and monitoring cleaning processes for equipment used to manufacture small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional products. The scope of his work involved drug substance and drug product manufacturing start-up, remediation, legacy justification, and increasing manufacturing capability. He has created lean CV strategies for document structure/flow and execution in every aspect of the cleaning validation process.
He was one of the authors on the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the cleaning validation acceptance criteria chapter lead.
Workshop agenda
Fred Ohsiek, Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk
Fred Ohsiek is the Sr Cleaning Validation Specialist for Novo Nordisk in Clayton, NC. He earned his Bachelor in Chemistry from University of South Florida. His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 20 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Ben Venue Laboratories, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk.
His cleaning validation experience includes risk assessments, cleaning development, validation, and monitoring cleaning processes for equipment used to manufacture small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional products. The scope of his work involved drug substance and drug product manufacturing start-up, remediation, legacy justification, and increasing manufacturing capability. He has created lean CV strategies for document structure/flow and execution in every aspect of the cleaning validation process.
He was one of the authors on the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the cleaning validation acceptance criteria chapter lead.
Fred Ohsiek, Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk
Fred Ohsiek is the Sr Cleaning Validation Specialist for Novo Nordisk in Clayton, NC. He earned his Bachelor in Chemistry from University of South Florida. His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 20 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Ben Venue Laboratories, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk.
His cleaning validation experience includes risk assessments, cleaning development, validation, and monitoring cleaning processes for equipment used to manufacture small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional products. The scope of his work involved drug substance and drug product manufacturing start-up, remediation, legacy justification, and increasing manufacturing capability. He has created lean CV strategies for document structure/flow and execution in every aspect of the cleaning validation process.
He was one of the authors on the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the cleaning validation acceptance criteria chapter lead.
Quick review of regulatory requirements and guidelines
Initial cleaning validation risk assessment
Building the CV program using the risk assessment
Fred Ohsiek, Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk
Fred Ohsiek is the Sr Cleaning Validation Specialist for Novo Nordisk in Clayton, NC. He earned his Bachelor in Chemistry from University of South Florida. His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 20 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Ben Venue Laboratories, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk.
His cleaning validation experience includes risk assessments, cleaning development, validation, and monitoring cleaning processes for equipment used to manufacture small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional products. The scope of his work involved drug substance and drug product manufacturing start-up, remediation, legacy justification, and increasing manufacturing capability. He has created lean CV strategies for document structure/flow and execution in every aspect of the cleaning validation process.
He was one of the authors on the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the cleaning validation acceptance criteria chapter lead.
Stage 1 cleaning validation documents
Stage 2 cleaning validation documents
Essential cleaning validation documents
Lean CV protocols and execution
Fred Ohsiek, Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk
Fred Ohsiek is the Sr Cleaning Validation Specialist for Novo Nordisk in Clayton, NC. He earned his Bachelor in Chemistry from University of South Florida. His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 20 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Ben Venue Laboratories, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk.
His cleaning validation experience includes risk assessments, cleaning development, validation, and monitoring cleaning processes for equipment used to manufacture small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional products. The scope of his work involved drug substance and drug product manufacturing start-up, remediation, legacy justification, and increasing manufacturing capability. He has created lean CV strategies for document structure/flow and execution in every aspect of the cleaning validation process.
He was one of the authors on the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the cleaning validation acceptance criteria chapter lead.
Quick review of FDA 2011 Continued Process Verification (CPV) regulatory guidelines
In-depth discussion on periodic review, CPV, and dated validation packages
Risk-Based approaches to Continued Process Verification
Reducing routine monitoring frequency
Fred Ohsiek, Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk
Fred Ohsiek is the Sr Cleaning Validation Specialist for Novo Nordisk in Clayton, NC. He earned his Bachelor in Chemistry from University of South Florida. His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 20 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Ben Venue Laboratories, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk.
His cleaning validation experience includes risk assessments, cleaning development, validation, and monitoring cleaning processes for equipment used to manufacture small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional products. The scope of his work involved drug substance and drug product manufacturing start-up, remediation, legacy justification, and increasing manufacturing capability. He has created lean CV strategies for document structure/flow and execution in every aspect of the cleaning validation process.
He was one of the authors on the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the cleaning validation acceptance criteria chapter lead.
Case study for determining CPV frequency and testing and then reducing frequency
Case study for re-validating legacy cleaning processes
Fred Ohsiek, Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk
Fred Ohsiek is the Sr Cleaning Validation Specialist for Novo Nordisk in Clayton, NC. He earned his Bachelor in Chemistry from University of South Florida. His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 20 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Ben Venue Laboratories, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk.
His cleaning validation experience includes risk assessments, cleaning development, validation, and monitoring cleaning processes for equipment used to manufacture small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional products. The scope of his work involved drug substance and drug product manufacturing start-up, remediation, legacy justification, and increasing manufacturing capability. He has created lean CV strategies for document structure/flow and execution in every aspect of the cleaning validation process.
He was one of the authors on the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the cleaning validation acceptance criteria chapter lead.
Sr Validation Manager instead of Sr Global Technical Manager
Novo Nordisk
Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk
Fred Ohsiek is the Sr Cleaning Validation Specialist for Novo Nordisk in Clayton, NC. He earned his Bachelor in Chemistry from University of South Florida. His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 20 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Ben Venue Laboratories, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk.
His cleaning validation experience includes risk assessments, cleaning development, validation, and monitoring cleaning processes for equipment used to manufacture small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional products. The scope of his work involved drug substance and drug product manufacturing start-up, remediation, legacy justification, and increasing manufacturing capability. He has created lean CV strategies for document structure/flow and execution in every aspect of the cleaning validation process.
He was one of the authors on the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the cleaning validation acceptance criteria chapter lead.
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