Latest news with #StallergenesGreer
Associated Press
4 days ago
- Business
- Associated Press
FDA Inspection Preparedness and Compliance Course Webinar: Fundamentals and the Ground Rules on How to Prepare for and Survive an FDA Inspection
DUBLIN--(BUSINESS WIRE)--Jun 4, 2025-- The 'FDA Inspection Preparedness and Compliance' training has been added to offering. This is a practical, hands-on two-day seminar designed to provide pharmaceutical, biopharmaceutical, biologics and medical device professionals with the information and tools they require to prepare for and manage an FDA inspection efficiently, effectively and successfully. Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. The course will go through what typically goes on during an FDA Inspection and will then cover how to prepare for, host and follow up to a regulatory inspection. It will emphasize and focus on the critical and vital elements that you should do or not do during the inspection. Typically, FDA inspections can be highly structured and there are procedures that are to be followed as you prepare for state of readiness. It is important for anyone who might be involved in the inspection to be aware of these procedures, including all employees and personnel to ensure there are no surprises. The course will also provide information for inspections conducted by international agencies as well as non- FDA agencies, including self-inspections for manufacturing and the famous FDA Mock Inspection or Mock Audit. It will explain how to prepare for an inspection, how to handle a scheduled or non-scheduled inspection, what to expect during an inspection and what follow up to expect after an inspection. Who Should Attend: This seminar will provide an overview and in-depth snapshot of the entire process for preparing for and managing and FDA inspection and external regulatory inspections and for those companies who must establish proven and sustainable GXP Compliance Strategies and risk mitigation strategies when responding to a crisis. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a 'refresh' overview of the FDA inspection process from preparing for the inspections, during the inspections and post-inspection responsibilities and follow up activities with FDA, including: This training Seminar includes the following for each registered attendee: Key Topics Covered: Day 1 Day 2 Recap of Day 1 and Day 2 Exercise on Day 2 Debrief/Adjourn/Wrap-Up Speakers: Kelly Thomas Vice President Stallergenes Greer Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries. For more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. View source version on CONTACT: Laura Wood, Senior Press Manager [email protected] For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 KEYWORD: INDUSTRY KEYWORD: PHARMACEUTICAL HEALTH MEDICAL DEVICES SOURCE: Research and Markets Copyright Business Wire 2025. PUB: 06/04/2025 09:47 AM/DISC: 06/04/2025 09:45 AM
Associated Press
17-04-2025
- Business
- Associated Press
Efficient Batch Record Design and Review Certificate Course: Paving the Way for Enhanced Efficiency in Regulatory Compliance (ONLINE EVENT: May 7-8, 2025 & ON-DEMAND)
DUBLIN--(BUSINESS WIRE)--Apr 17, 2025-- The 'Efficient Batch Record Design and Review Certificate Course' training has been added to offering. This online training is designed for professionals in the Pharmaceutical, Medical Device, and other life science industries. This Education Course is designed for all persons in Production and Quality Units who deal with the design and review of batch documentation in pharmaceutical, biopharmaceutical and API production. It is also addressed to Qualified Persons who want to improve their system of the batch record review. Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process to demonstrate compliance. A strong batch record review system is essential to properly document all critical and operational process parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc. Several examples and case studies of best practices will be demonstrated to emphasize how an effective batch record review is conducted based on current quality/regulatory requirements. In this accredited training, we will identify and discuss Master Batch Records (MBR), regulatory requirements, and key steps for issuance, batch record review, reconciliation, and final QA disposition. It will be especially valuable to the personnel and management, including senior management, in these areas: Key Topics Covered: Regulatory Requirements applying to Batch Record Review, Pharmaceutical Documentation & the Quality System The Design of the Master Batch Documentation Efficiency in Batch Record Review Risk Assessment/ Management Applications within the Batch Record Process Change Controls QA Oversight on EBR validation activities Speakers: Kelly Thomas Vice President Stallergenes Greer Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries. For more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. View source version on CONTACT: Laura Wood, Senior Press Manager [email protected] For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 KEYWORD: INDUSTRY KEYWORD: SCIENCE OTHER SCIENCE PHARMACEUTICAL HEALTH MEDICAL DEVICES EDUCATION TRAINING OTHER HEALTH SOURCE: Research and Markets Copyright Business Wire 2025. PUB: 04/17/2025 08:24 AM/DISC: 04/17/2025 08:24 AM
Yahoo
14-04-2025
- Health
- Yahoo
Aptar Digital Health Reports Positive Impact of iPUMP® on Sublingual Liquid Allergen Immunotherapy Adherence
CRYSTAL LAKE, Ill., April 14, 2025--(BUSINESS WIRE)--Aptar Digital Health, a global leader in digital health solutions enhancing the patient experience, today announces the positive results from the SPEED1 survey, showcasing the impact of the iPUMP® connected assistant on adherence to Stallergenes Greer's sublingual liquid immunotherapy (SLIT). The results will be presented by Stallergenes Greer, a global leader in allergy therapeutics and long-standing partner of Aptar Digital Health, at the upcoming CFA congress (Congrès Francophone d'Allergologie) in Paris, France from April 15 to 18, 2025. The SPEED survey showed a 15% increase in treatment adherence for patients using iPUMP®. Moreover, for children aged between 5 and 12 years, parental involvement in treatment administration dropped from 50% to 28% over three months, while the proportion of children independently taking their medication rose from 24% to 58%. Notably, 90% of parents felt reassured by the connected assistant, with half of them feeling completely at ease with treatment administration, compared to 36% of respondents in the non-iPUMP® group. iPUMP®, developed in conjunction with Stallergenes Greer, supports adherence to personalized SLIT treatments by helping to ensure patients adopt the correct dosing technique, duration and frequency of treatment. This innovative and easy-to-use tool is connected to a companion mobile application and provides direct access to the personalized treatment protocol prescribed to each patient by their physician. Launched in February 2023 in France, it has been used by over 9,000 patients to date. iPUMP® helps support patients in improving treatment adherence to optimize effectiveness while offering a history-tracking function for precise medication monitoring. By supporting Stallergenes Greer in their mission to empower individuals and improve treatment outcomes, Aptar Digital Health fosters its go-to partner position in the pharmaceutical industry for the development and operation of digital health and connected solutions. Elena Rizova, Chief Medical Officer at Stallergenes Greer, stated, "Findings of the SPEED survey underscore the role of connected health solutions in improving both treatment adherence and patient confidence, which are key elements in achieving successful therapeutic outcomes." She added, "Innovation is at the heart of what we do and iPUMP®, by catering to the needs expressed by patients and healthcare professionals, meets their expectations and provides a solution to enhance treatment management and overall allergy care." Marcus Bates, VP Business Development & Global Head of Respiratory at Aptar Digital Health, commented, "The strong results of the SPEED survey pave the way for wider adoption of digital and connected solutions for allergy management, enabling new patients to access a simple, easy-to-use solution that can help track adherence and stay engaged to achieve better health outcomes." The SPEED survey results establish a strong foundation for broader adoption of iPUMP®, supporting Stallergenes Greer's commitment to innovate for the benefit of patients, caregivers and the medical community. About Aptar Digital Health Aptar Pharma's Digital Health division is part of AptarGroup, Inc., a global leader in drug and consumer product dosing, dispensing and protection technologies. Aptar Digital Health creates end-to-end solutions to enhance patient experiences every day, leveraging a holistic ecosystem of digital interventions. Amplified by an industry-leading portfolio of products and solutions, Aptar Digital Health's offering combines mobile and web apps, Software-as-Medical-Device, connected drug delivery systems, advanced data analysis services, and patient onboarding and training solutions to actively empower patients and create a positive treatment journey. Aptar is headquartered in Crystal Lake, Illinois and has more than 13,000 dedicated employees in 20 countries. For more information, visit and About Stallergenes Greer Headquartered in Baar (Switzerland), Stallergenes Greer is a global healthcare company specialising in the diagnosis and treatment of allergies through the development and commercialisation of allergen immunotherapy products and services. Supported by more than 100 years of expertise and innovation, our products are available for patients in over 40 countries. For more information, visit 1 The SPEED real-life study was conducted by AplusA for Stallergenes Greer between May 29 and November 29, 2024. This online questionnaire, aimed at measuring the impact perceived by patients after three months of treatment with allergen immunotherapy (AIT) using Aptar Digital Health's iPUMP® connected assistant, included 104 pediatric patients over 5 years of age and 77 adolescent and adult patients over 13 years of age. View source version on Contacts Media Contact: Ciara JacksonAptar Pharma+49 151 1951
Associated Press
28-01-2025
- Business
- Associated Press
Virtual Efficient Batch Record Design and Review Course: Master Batch Records (MBR), Regulatory Requirements, Key Steps for Issuance, Reconciliation, and Final QA Disposition (ON-DEMAND)
The 'Efficient Batch Record Design and Review' training has been added to offering. This accredited training will identify and discuss Master Batch Records (MBR), regulatory requirements, and key steps for issuance, batch record review, reconciliation, and final QA disposition. This online training is designed for professionals in the Pharmaceutical, Medical Device, and other life science industries. This Education Course is designed for all persons in Production and Quality Units who deal with the design and review of batch documentation in pharmaceutical, biopharmaceutical and API production. It is also addressed to Qualified Persons who want to improve their system of the batch record review Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process to demonstrate compliance. A strong batch record review system is essential to properly document all critical and operational process parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc. Several examples and case studies of best practices will be demonstrated to emphasize how an effective batch record review is conducted based on current quality/regulatory requirements. It will be especially valuable to the personnel and management, including senior management, in these areas: Quality Assurance Quality Control Facilities Manufacturing Validation Professions in GMPs and Pharmaceuticals Agenda Regulatory Requirements Applying to Batch Record Review, Pharmaceutical Documentation & the Quality System Global regulations and expectations Regulations Update and Latest Developments in Industry How documentation fits into the Quality System of recommendations and regulations Important data for Quality Assurance Risk Assessment and Continuous Improvement The Design of the Master Batch Documentation Is there a need for re-design? Important aspects to consider How to gain efficiency Efficiency in Batch Record Review Layout and handling How to reduce review time: examples How to handle and document deviations How to present review results to the QP Balanced Score Card KPIs Risk Assessment/ Management Applications within the Batch Record Process How the risk lifecycle links with the BRR stages: Risks associated with paper and electronic records Risks associated with people checking documentation Relative risk factors Risks associated with the process Risks for QP 'discretion' Quality Risk Management Impact the effectiveness of deviations, OOS Change Controls Improvement of root cause investigations Using QRM to perform a SWOT analysis What does a good risk assessment look like? QA Oversight on EBR validation activities Validation Life Cycle Qualification activities Maintenance Training Speakers: Kelly Thomas Vice President Stallergenes Greer Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as all areas of validation including process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries. For more information about this training visit is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Laura Wood, Senior Press Manager For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 KEYWORD: SOURCE: Research and Markets Copyright Business Wire 2025. PUB: 01/28/2025 06:18 AM/DISC: 01/28/2025 06:18 AM
