This presentation will provide information and insight into recent and relevant regulations for ATMPs that can derail the approval process. From materials, cryopreservation, logistics, manufacturing, and facility design, this session will provide pragmatic strategies and tools to navigate the complex scientific and regulatory environment. Attendees will gain a greater understanding of ATMP cryopreservation, facility design, logistics, and regulatory classifications and will leave with the knowledge to assess complex subjects associated with ATMP production and have confidence in communication with regulators during interactions.

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  Gerry McKiernan (Moderator)

  Director of Quality at Cell Therapies

This presentation will cover the following topics:

Facility designs for ATMPS 1. Regulatory Compliance 2. Cross Contamination 3. Biosafety 4. Lean 5. Operational readiness 6. Operational excellence

Unit operations 1. Equipment design for commercial scale production in a heavily regulated industry. 2. Automation - Robots and Collaborative-bots. Can we replace the human? 3. New unit operations and technologies – these need to be accommodated. 4. Closed processing and the use of Aseptic Isolators – what are the challenges? 5. Disruptive Technologies – what can we leverage from other sectors in Industry

Patient Safety 1. Sterile boundaries and aseptic processing. 2. Managing Risk 3. Quality by design 4. Supply chain challenges

Kevin Smyth, BE, MICHEME, CENG, Global Director Process Technology, Global Strategy and Technology Group, IPS-Integrated Project Services

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  Kevin Smyth

  Global Director Process Technology, Global Strategy and Technology Group of IPS

GMPs used to say "what to do", but avoid "how to do it." There is a shift to detail-oriented "GMP" instructions, resulting from a few seminal events: Barr court case, DEG contaminated glycerol; Heparin fraud/ supply chain, data integrity and drug shortages. EU GMPs require Risk Management, yet e.g. Annex 1 revisions, Chapter 5 checklist of measures to "prevent" cross contamination leave little room for risk-based thinking. In the US, legislative hurdles to GMP revisions, result in detailed guidance. PIC/s, EU GMP Part III "Regulatory "expectations," WHO, ISO, Pharmacopoeias, inspector's personal opinion...companies are drowning in overlapping requirements/expectations. Regulator and industry appear to be in collusion to ensure failure. GMPs with all the minutiae, allow deviations and product release provided a "risk assessment " shows no impact. In stark contrast, ISO 9001:2015 makes a crucial point: One of the key purposes of a quality management system is to act as a PREVENTIVE tool." A model for an effective, risk-based thinking, #PREVENT QMS will be proposed, restoring GMPs to their rightful place and allowing controlled disruption and regeneration of our stagnating industry.

Karen Ginsbury, BPharm, MSc, Owner, PCI Pharmaceutical Consulting Israel

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  Karen Ginsbury

  Owner at PCI Pharmaceutical Consulting Israel

Improvisation does not happen by itself, it happens only through change, but bringing change is a great challenge. The key to driving sustainable performance and health across all levels in an organization is a tall order, yet teams are doing this well, with new ways of revamping competency-building programs. These new approaches focus on helping employees develop the required knowledge, skills, and behaviors. This session is a must-go-to for all leaders in the operational domains because the speakers will share examples of failures. Listening to the speakers will help provide insights, tested tools, and pragmatic methodologies that will deliver for a higher success rate, regardless of the nature of the change program pursued. Aspects of leadership, elements of management, points for decision-making, must-haves for strategic planning, working in a matrix organization, and other skills related to organizational effectiveness will be the takeaways.

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  Lisa Bennett (Moderator)

  Senior Quality & Compliance Specialist at Cell Therapies

Data Integrity is coming under increasing scrutiny to assure that the information is obtained, recorded, transmitted, reported and acted on appropriately. Automation, when well designed and validated, will contribute a great deal to Data Integrity (DI), however many instances will continue to exist where data are recorded manually. Although organizations may add checking or verification activities to reduce the risk of loss of DI at that manual stage, it represents the greatest risk to DI.

The organization's Quality Culture offers the best mitigation to this risk, helping assure that the activity of recording data manually is done with integrity. Examples will be presented where operators made the wrong decision in recording data because they misunderstood the goals and objectives of the organization.

Christopher J. Smalley, MBA, MS, PhD, Compounding Pharmacist Advisor, ValSource Inc.

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  Christopher J. Smalley

  Compounding Pharmacist Advisor at Valsource Inc

Regulatory requirements are a major driving force for the development and implementation of appropriate visual inspection procedures. This session will provide an overview on visual inspection requirements; the current regulatory considerations; and the background and essential fundamentals of USP <790> criteria and <1790> guidance.

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  Lisa Bennett (Moderator)

  Senior Quality & Compliance Specialist at Cell Therapies

Rukman S. De Silva, PhD, Chemist/Product Quality Reviewer, Division of Biotechnology Review and Research IV, OBP, OPQ, CDER, U.S. FDA

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  Rukman S. De Silva

  Chemist/Product Quality Reviewer, Division of Biotechnology Review and Research IV, OBP, OPQ, CDER at U.S. FDA

Executing efficient and comprehensive particle investigations is critical in parenteral manufacturing. This session will provide an overview of particle investigation best practices as well as advanced particle identification techniques.

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  Michael Schafferius (Moderator)

  Application Specialist at Sartorius

Understanding your problem well is half the solution. Today we need a bigger emphasis on the source than on the post filling detection. This presentation will include a detailed case study of particulate matter in injectables starting from its detection, analysis, actions to identify the source of contamination and subsequent remediation. This will elaborate on the opportunities to plug some of these intrinsic and extrinsic sources which contribute to particulate contamination in injectables. It will guide the participants to go for standardization of the Materials( Packaging materials, consumables, product contact and non contact parts) and Procedures (e.g. C&D, AP Interventions etc.) in an aseptic manufacturing facility.

Subrata Chakraborty, MS Pharma, Principal Advisor, GxPFONT Consulting Group

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  Subrata Chakraborty

  Principal Advisor at GxPFONT Consulting Group

Several pharmaceutical manufacturers, especially in case of greenfield production environment, need to proceed in parallel with different activities in order to reduce the production startup timing. The use of a placebo product becomes extremely helpful to simulate the real product behavior during the prototyping and testing phases. Although placebo products should process the same physical features compared to the active products, there could be some intrinsic challenges when it comes to automatic inspection. The presentation will highlight advantages and criticalities of using placebo products during the setup and validation phases of an automatic inspection machine.

Massimo Frasson, General Manager, BREVETTI C.E.A. S.p.A.

Marion F. Joannes, Meng, Project Manager, DELPHARM ST REMY

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  Massimo Frasson

  General Manager at BREVETTI C.E.A. S.p.A.

The R&D pipelines are filled with products that target smaller patient groups compared to previous decades. In order to inspect and pack these medicines, state-of-the-art equipment and best-practices have to be scrutinized. Just-in-time delivery, cooling processes, the ability to inspect automatically as well as format flexibility impact requirements for new inspection and packaging lines. On the basis of the following examples new approaches of inspection & packaging will be envisaged: Numerous products have to be cooled under significant low temperatures. This requires space saving packaging to reduce cooling costs – and luckily there are ways to achieve that. Various parenteral dosage forms will run on the same inspection & packaging lines and demand a high flexibility in formats and fast format part changes. Processes will be completely automated to reduce human errors and avoid batch recalls. False ejects of any inspection station in the packaging line have to be reduced to avoid a costly re-inspection or disposal of the product. AI, Virtual Reality and object IDs will monitor the process quality through the process.

Christian Scherer, Executive Vice President Sales, Körber Pharma Inspection (Seidenader) (Invited)

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  Christian Scherer

  Executive Vice President Sales at Körber Pharma Inspection

The purpose of this document is to educate and provide guidance to teams willing to transit to AI applied to VI. We considered to pave the road considering pitfalls along the way, rather than strong set of recommendations as this is an emerging field. The Point to consider Document has been drafted by a team of 10 PDA volunteers. In 2020, we focused in setting up the team, agreement on targeted audience, document backbone and first draft compilation. We have now 1 draft that we have started to review and consolidate. This document is based on solid data science expertise of the team. The ultimate scope is to improve confidence and trust in AI for technical teams, quality staff et regulators.

Romain Veillon, PharmD, Senior Manager, Visual Inspection, GSK Vaccines

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  Romain Veillon

  Senior Manager, Visual Inspection at GSK Vaccines

TRAINING COURSE DESCRIPTION
Environmental surveillance is a tool utilized to evaluate the effect of controls on the manufacturing environment. A process to assess the cleanroom and other controlled environments of a pharmaceutical facility can serve as an adjunct to the sterility assurance program for the microbial quality of drugs.

The items addressed in this online training course include definitions, standards, surveillance support systems, system surveillance, validation systems, definitions and typical frequencies and levels.


LEARNING OBJECTIVES
Upon completion of this training course, the attendee will be able to:
- Apply current regulatory guidance to your environmental monitoring program
- Implement improved environmental monitoring procedures
- Compare and contrast new and existing environmental monitoring equipment
- Outline how to best utilize current environmental monitoring definitions
- Define key environmental monitoring concepts


WHO SHOULD ATTEND?
This training course is intended for professionals who are involved in the design and execution of an environmental monitoring program in sterile drug manufacturing.

Function Area(s): Quality Control (Analytical), Quality Control (Microbiology), Quality Systems, Quality Compliance, Manufacturing, Quality Assurance Operations, Technical Operations, Validation

Job Position(s): Analyst, Specialist, Operator/Technician, Supervisor, Manager

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  Marc Glogovsky

  Senior Microbiology Consultant at ValSource, Inc.