pharmaphorum

JUNE 8, 2022

Driving a Holistic Approach to Assurance of Product Sterility through Aseptic Manufacturing following QRM Principles. Conference Chairman: James Drinkwater, Head of Aseptic Processing Special Interest Group PHSS and Head of GMP Compliance, F Ziel GMBH. Discover a risk-based approach to cleaning and disinfection. Process Leaders.

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ISPE

NOVEMBER 22, 2022

I presented on planning and executing and designing fill lines, RABS, Isolators, and transfers – along with the differences between processing potent compounds versus non- potent compounds. Director Aseptic Processing SME. How are we approaching the QRM (quality risk management) approach that is now expected per Annex 1?

Compounding 98

Compounding Packaging Dosage Vaccines 98

ISPE

NOVEMBER 3, 2022

Real-time control processes exist now for bioprocesses, artificial intelligence (AI), and “super computers” to maintain process control, so potentially gene therapy production could be automated. Manager, Biotherapeutic Quality Division. Deputy Director of Science, Office of Pharmaceutical Quality. Convergence and More.

Communication 98

Communication FDA Documentation Vaccines 98

ISPE

NOVEMBER 1, 2022

2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients. 2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients. Quality and Stability. He presented on “Quality: A Key Ingredient for Stable Pharmaceutical Supply Chains.”. Quality, Defined.

FDA 98

FDA Insurance Chemotherapy Documentation 98

ISPE

DECEMBER 13, 2022

Building off of the success of the 2022 ISPE Aseptic Conference , the program committee has developed a robust program covering key areas in aseptic manufacturing, processing, and filling for students, emerging leaders, and seasoned industry professionals. The program committee hopes to see you in North Bethesda, MD from March 5th to the 7th.

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Dosage FDA 52

ISPE

OCTOBER 28, 2022

was published in 2019, most of the attention was focused on the incorporation of quality risk management (QRM) into the integrated commissioning and qualification (C&Q) approach. Just as QRM drives effectiveness of the integrated C&Q process, GEP drives the efficiency of that process.

Documentation 98

Documentation 98

ISPE

JULY 6, 2023

Applying a systemwide risk management (SRM) approach to manufacturing is essential to ensuring manufacturing projects are vetted in a comprehensive and consistent manner. Understanding and managing these risks is central to any decision to greenlight CM in a production-ready environment.

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Insurance Documentation Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

JANUARY 16, 2023

There is an expectation that more thorough, science-based quality risk assessments are developed and that these are ‘proactive’, in terms of looking for contamination risks before they occur. All require aseptic manipulation, hence have microbial contamination risks.

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Vaccines FDA Research Laboratories Documentation 127

ISPE

JANUARY 9, 2023

GAMP ® 5 Guide, 2nd Edition , aims to continue to protect patient safety, product quality, and data integrity by facilitating and encouraging the achievement of computerized systems that are effective, reliable, and of high quality. It was time for ISPE to update this key guidance document to reflect technological progress.

Documentation 52

Documentation FDA Communication 52

ISPE

JULY 6, 2023

This article provides a review on the current state of CM implementation, offers insights into life cycle management and regulatory aspects, and explains how a data- and knowledge-centric approach to risk management can help CM achieve its full potential. It is recognized as a key process intensification approach.

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

SEPTEMBER 12, 2022

Director, Office of Pharmaceutical Quality Operations. Deputy Director, Office of Manufacturing Quality. Director External Engagement and Supplier Quality. If health information arises from donor information, there are also risk-reducing actions that can be considered as alternative to recalls. Panelists: Alonza Cruse.

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FDA Documentation Communication 52

ISPE

OCTOBER 26, 2022

ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints. These processes may still have open aseptic steps.

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Vaccines Compounding Documentation FDA 97