John F. Kelly, Vice President, Quality Operations and Environment, Health & Safety, Pfizer Global Supply (Invited)

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  John F. Kelly

  Vice President, Quality Operations and Environment, Health & Safety at Pfizer Global Supply

Ensuring safe reliable supply of pharmaceutical medicines is of critical importance for the patients that the industry serves. This presentation will be a discussion on how the industry can transition, through Industrial Revolution 4.0, to provide quality products through Aseptic Parametric Release of Parenteral Products. This will allow streamlined manufacturing, packaging and delivery processes reducing time and resource utilization for the industry. Patients will benefit from this transition and the ability of the industry to safely and reliably provide medicines.

Frederic Ayers, PhD, Research Scientist, Eli Lilly and Company (Invited)

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  Frederic Ayers

  Research Scientist at Eli Lilly and Company

Gamma sterilization of single-use systems used in biologics manufacturing, is facing increasing capacity and business continuity constraints driving the need to qualify alternate sterilization approaches within the next 2 to 3 years. With advancements in accelerator technologies, X-ray sterilization is now a mature sterilization technology being used for sterilization of medical devices, with the basic requirements well-described within the tenants of ISO11137. Herein we risk assess similarities and differences in X-ray and gamma irradiation, leading to an industry risk assessment approach supporting qualification of X-ray sterilization for single-use consumables.

I will be sharing with you the rationale behind the qualification approach, data on evaluating materials attributes of typical single-use components following X-ray and gamma sterilization, including sterility, integrity, extractables, integrity, and performance data. As single-use systems are highly customized to individual drug manufacturing operations, qualification of x-ray sterilization for biotech applications will require strong cross-industry education, cooperation and sharing of results to ensure a comprehensive solution.

James J. Hathcock, PhD, Senior Director, Regulatory and Validation Strategy, Pall Biotech

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  James J. Hathcock

  Senior Director, Regulatory and Validation Strategy of Pall Biotech

In this session, thought leaders introduce advanced ways of working in process validation, the use and misuse of aseptic process simulations, and an update on where we are with Pre-Use/Post Sterilization Integrity Testing.

*This will be covered in the following 5 sessions.

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  Bruce Loxley (Moderator)

  Senior Manager - Audit I&TPO at GlaxoSmithKline Vaccines

The presentation discusses where MAC fits in the larger picture of a risk-based Cleaning Validation lifecycle and includes a review of the conceptual and mathematical approaches to calculating MSC / MAC.

Examples of three approaches, including sample equations, which will be covered and dissected to provide understanding of the equations and source of the data which replaces the variables in the equations. An assessment of the applicability of each approach/equation, from a regulatory and risk perspective will be included in the presentation.

Finally, a case study which illustrates which equations were used for specific carry over scenarios by operating companies, and why they used them.

Javier Cardenas, PhD, Senior Consultant, Azzur (Invited)

Susan B. Cleary, BCS, MBA, Director Product Development, Novatek International

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  Javier Cardenas

  Senior Consultant at Azzur
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  Susan B. Clearly

  Director Product Development of Novatek International

Aseptic process simulations or media fills have long been a basic principle and regulatory expectation for aseptic process validation. However, understanding of their ability to ensure process performance and product sterility has, at times, been misunderstood and over-relied upon. This is especially relevant in regard to challenges faced by the manufacture of new advanced therapies, use of new technologies, and sustainable product supply. Although the APS has a significant role to play, they should not be considered as the sole means to validate the aseptic process. The APS alone is not designed or scientifically capable to determine process duration, fatigue effect, equipment capability, environmental conditions, or intervention validity. Using APS to do more than it is designed to do can result in poor understanding of process capability, de-emphasis of available scientific evidence, burdensome protocol, a false sense of security and a lowering of sterility assurance. A closer look at how we traditionally validate aseptic processes and assure sterility is needed. To that end, this presentation will present a risk-based view of APS limitations and benefits and explore ways to improve aseptic process validation.

Hal Baseman, MBA, Chief Operating Officer, ValSource Inc.

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  Hal Baseman

  Chief Operating Officer at Valsource Inc

The last Annex 1 included a paragraph, which stated that a sterilized filter requires to be integrity tested pre-use. This pre-use/post sterilization test, also known as PUPSIT, can increase the complexity of a sterilizing grade filtration system and a variety of considerations have to be evaluated to see whether it is possible to implement such test or what would be required. The complexity in design and handling can cause an elevated risk to perform such test and it was debated over the last 15 years. To gain a better understanding and a platform to make decisions, PDA and Biophorum joined in a consortium, SFQRM, which had four workgroups with different tasks establishing data, which support both, the regulatory and end-user decision process. The talk will review the different discussions, the data established and the result interpretation.

Maik W. Jornitz, CEO, G-CON Manufacturing Inc.

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  Maik Jornitz

  President & CEO of G-CON Manufacturing

Quality Risk Management (QRM) and Knowledge Management are foundational elements of our industry today. This session will examine both of these topics and how they can be applied. The session will also examine a model for ensuring successful aseptic operations governance through structure, skills and competencies.

*This will be covered in the following 5 sessions.

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  Max Fernandez

  Senior Director, Global Regulatory Affairs of Samsung Biologics

Physical and chemical properties of a container closure system for parenterals may affect the drug manufacturing process, product quality, and patient safety. In the case of a lyophilized product, the risks are mainly associated with Design for Manufacturability and impact on product quality.
An extended stability study was designed to evaluate the effects of three halobutyl elastomer formulations used for lyophilization stoppers on drug product leachables, residual moisture and container closure integrity of a model lyophilized preparation. The simulated liquid drug product was filled into vials and subsequently lyophilized using suitable lyophilization processing parameters. Stored at controlled room temperature, the lyophilized preparation will be analyzed periodically over 4 years. Real time storage data up to 6 months will be presented. The chemical and physical data generated provide a better understanding of potential risks.
This presentation will showcase a comprehensive approach to understand potential risks to lyophilized drug product quality based on chemical and physical performance testing. The discussion will cover key considerations in the design of a lyophilized drug product packaging study leveraging this analytical approach.

Diego A. Zurbriggen, Technical Account Manager, West Pharmaceutical Services, Inc.

Samantha Singer, MS, Scientist I/Project Director,Lyophilization Technology Inc.

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  Samantha Singer

  Scientist I/Project Director of Lyophilization Technology Inc.
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  Diego A. Zurbriggen

  Technical Account Manager at West Pharmaceutical Services, Inc.

Expectations to apply the best available knowledge, experience, expertise, learnings and know-how are woven throughout regulatory and industry guidance, not just in ICH Q10 where knowledge management (KM) is prominently presented as a pharmaceutical quality system enabler. Indeed, knowledge is expected to be managed across the product lifecycle to ensure product realization, establish a state of control, a basis for continual improvement, reduce risk to patients, and enable favorable business outcomes.

This presentation will outline a progression in the application of knowledge management to help satisfy these expectations. First, a case study will illustrate pragmatic practices to improve the transfer of tacit knowledge during technology transfer, including favorable outcomes observed. Second, ‘zooming out’ to consider technology transfer in aggregate as a key lifecycle activity, a knowledge transfer enhancement (KTE) framework is presented to improve and standardize knowledge transfer, based on deficiencies in current practice. Finally, a discussion with a supporting framework on how to better integrate knowledge management and quality risk management (QRM), as a means to drive more informed risk-based decision making and ultimately reduce risk to patients. This is made possible by drawing on the best knowledge available to the organization – by managing knowledge as an asset.

Martin J. Lipa, Executive Director, Knowledge Management, Merck & Co., Inc.

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  Martin J. Lipa

  Executive Director, Knowledge Management of Merck & Company Inc.

TRAINING COURSE DESCRIPTION

The objective of aseptic processing is to prevent the microbiological contamination of sterile product manufactured using the process. The verification of the ability of the process to produce sterile product is evaluated by aseptic process simulation studies or media fills.

This training course is based on PDA Technical Report No. 22: Process Simulations for Aseptically Filled Products, as well as relevant topics from PDA Points to Consider for Aseptic Processing: Part 2, and the EMA draft Annex 1 revision. The training course will address various elements required in the design and execution of aseptic process simulations to include personnel qualification, media selection and preparation, filling considerations, interventions, duration and number of units filled, pre and post incubation inspections, incubation conditions, acceptance criteria and investigations and corrective actions. The use of risk-based decision making will be considered.


LEARNING OBJECTIVES
Upon completion of this training course, the attendee will be able to:
- Identify the updated scientific and regulatory technology and expectations in the design, operation and interpretation of process simulations
- Discuss process simulation concepts and principles such as the number and frequency of simulations, worst case and risk assessment and ongoing evaluations
- Describe how to use risk management as it applies to aseptic processing simulations
- Discuss how process simulations can be applied to various types of aseptically processed products (lyophilized products and powders)
- Discuss the necessary documentation associated with process simulations
- Apply modern concepts to establish appropriate acceptance criteria for aseptic process simulations, evaluate the results and as necessary investigate any failures and recommend appropriate corrective and preventive actions


WHO SHOULD ATTEND?
This training course is intended for professionals who are involved in aseptic process simulations.

Function Area(s): Quality Control (Microbiology), Quality Systems, Quality Compliance, Engineering, Manufacturing, Quality Assurance Operations, Regulatory Affairs, Technical Operations, Training, Validation

Job Position(s): Specialist, Operator/Technician, Supervisor, Manager, Director, Engineer, Scientist, Auditor/Inspector

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  Hal Baseman

  Chief Operating Officer at Valsource Inc