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1
FDA Compliant SOPs for Regulated Industry — FDA Compliant SOPs for Regulated Industry: How to Create High Quality SOPs that Your Team and FDA Auditors Will Love
23 May 2024 - 24 May 2024 • washington dc, United States
Organizer:
FDAMap
Abstract:
SOP deficiencies are one of the top 5 findings in FDA audits. The entire Quality Management System (QMS) of an organization could be severely compromised due to SOP defects. Formal written Standard Operating Procedures (SOPs) are required both by the FDA and EMA. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This workshop will provide step by step instructions to create SOPs for FDA-regulated organizations.
Topics:
FDA, SOPs, Quality Management System, Clinical Trials, Clinical Studies, Clinical Research, Clinical Development, FDA Regulation, FDA Complience
Event listing ID:
1601735
2
510(k) Submissions — 510(k) Submissions to the FDA: Hands-On Workshop
30 May 2024 - 31 May 2024 • Washington DC, United States
Organizer:
FDAMap
Abstract:
Each year FDA receives about 3000 applications for new devices via the 510k process, and about 60% of them are rejected either for poor quality application that cannot even be reviewed or for other technical reasons. Submissions to the FDA that are poorly organized, do not follow current practices, contain inconsistencies between documents, have missing or incomplete content, or poor structure will result in significant delays in the clearance process. With multiple review cycles, up to 90 days each, rejections by FDA could stretch the 510k clearance time-lines to 8 months or more. Most of the refuse-to-accept deficiencies are due to the inexperience of the 510k writers, who ignore the FDA rules. Writing and assembling a complete and well structured 510(k) submission will certainly improve the likelihood of FDA clearance on the first round.

This hands-on workshop is done by one of the industry’s top regulatory expert. The trainer has performed numerous reviews of 510(k) submissions over the last 15 years, and has analyzed the reasons that most often lead to delays in getting submissions ultimately cleared by FDA. This hands-on workshop will walk the attendees through the structure and key elements of the 510(k) submission and explains in clear language the most common pitfalls to avoid in the development of your 510(k) submission to the FDA.

Topics:
FDA, 510 K Submission, 510 K Writers, FDA Compliance, FDA Regulations,
Event listing ID:
1615972
3
Online Training Session — Quality by Design in Pharmaceutical Development
10 Jun 2024 - 14 Jun 2024 • Online Platform, Any Location (virtual event)
Organizer:
Scientific Update Ltd.
Event listing ID:
1607423
4
From Genetic Discoveries to Gene Function in Human Diseases Conference
13 Jul 2024 - 16 Jul 2024 • Lisbon, Portugal
Organizer:
Fusion Conferences
Abstract:
This conference aims to include recent progress in translating human genetic discoveries into functional characterization of genome wide association study (GWAS) regions that encode risk for complex human diseases. This symposium will highlight a number of exemplary functional studies of GWAS loci, examine how single cell data can accelerate translation of genetic associations, and how we can expand our catalogs of causal genes using the new CRISPR-Cas9 screening tools.
Abstract submission deadline:
01 Feb 2024
Event listing ID:
1589856
5
PHARMA INDIA EXPO 2024
18 Jul 2024 - 20 Jul 2024 • Hyderabad, India
Organizer:
INDIAN EXHIBITION SERVICES
Abstract:
This Expo an International Exhibition & Conference on Pharma- Healthcare- Technologies focuses on Future of Pharma & Healthcare Industries to be converting in a Pure Digital Renovating Worldwide.

All the professionals from across the globe will converge to share their knowledge, leading to the future assets. To create an international event which will be a focused and dedicated platform for professionals from major industries like Pharma, IT, Healthcare, & Start-ups to discuss, and share knowledge, expertise and experience.

The Expo & conference is expected to be attended by more than 500 delegates & 400 + Exhibitor across the Globe, including researchers, Healthcare & Pharma Technology authorities, and enforcement agencies, practitioners, policymakers, industry representatives, academicians and students working in the fields of life Science, Technology and Healthcare.

To discuss on potential solutions and researches that will highlight current science, management issues and new directions benefiting the industry in various regions.

Public sector, private industry and service providers are rapidly transforming with technology commotions and integrations. We understand and analyse the trends and collaborate with the government to provide a better service to Industry Stakeholders.

Technology upgradation in Pharma & Healthcare sectors through right tools and technologies is imperative. Our offerings bridge the gap for solution providers, regulators, Policymakers and educators, facilitating creation of the new world order in the Pharma & Healthcare Technical spectrum.

Pharma India Expo - the leading International Exhibition & Conference on Pharma- Healthcare- Technologies Industries- is the perfect place for the open to networking, exchange of knowledge, ideas and information. The industry meeting of the year offers an overview for the entire Industry Expert of all important findings and innovations in the industry

Discover the products, services and solutions from around 400+ exhibitors. Experience a compact, certified lecture program with over 200 contributions from more than 100 speakers and gain a lot of knowledge in a short time. Exchange ideas with colleagues and expand your network with new, valuable contacts, which takes place parallel to Pharma India Expo, health politicians and professional representatives set the course for the future of the industry.

Contact:
PHARMA INDIA EXPO;     Phone: [08448193089];     Email: milan@ies-india.com
Topics:
pharma, pharmaceutical, expo, industry,
Event listing ID:
1585076
6
Model-Informed Drug Discovery and Quantitative Systems Pharmacology: Key Applications, Opportunities and Challenges
09 Aug 2024 - 11 Aug 2024 • Banff, Alberta, Canada
Organizer:
Banff International Research Station (BIRS) for Mathematical Innovation and Discovery
Abstract:
Drug design and development are costly and lengthy. Mathematical and computational modelling anchored in model-informed drug development (MIDD) and quantitative systems pharmacology (QSP) methodologies are integral to accelerating the R&D pipeline. In parallel, MIDD and QSP can be used to better understand the biological basis of drug responses and fuel new biomedical research paths. This workshop will bring together experts in the fields of MIDD and QSP with the goal of strengthening ties between industrial and academic researchers and advancing these exciting fields.
Event listing ID:
1605106
7
ipharma@2024 — International Pharmaceutical Business Expo 2024
16 Aug 2024 - 17 Aug 2024 • Boston, United States
Organizer:
i Pharma Expo
Abstract:
iPharma Expo 2024, USA (International Pharmaceutical Business Expo 2024) scheduled during August 16- 17, 2024 , at Boston, USA.
Contact:
Phone: [(617) 275-2612];     Email: kathy@ipharmaexpo.net
Topics:
Pharma Expo, pharma congress, pharma Expo USA, pharmaceutical event, pharma USA, pharmaceutical expo, international pharma, iPharma USA
Event listing ID:
1613190
8
Beilstein Nanotechnology Symposium — The Next Generation of Nanomedicines
03 Sep 2024 - 05 Sep 2024 • Rüdesheim, Germany
9
IC2AR 2024 — 6th International Caparica Conference in Antibiotic Resistance 2024
08 Sep 2024 - 12 Sep 2024 • Costa da Caparica – Lisboa, Portugal
Abstract:
In the last years, there is a great concern about the problem of bacterial resistance to antibiotics used in human medicine as well as in veterinary. The use of antibiotics constitutes an important factor for selection of resistance, not only among pathogenic bacteria but also among the commensal ones. Antimicrobial resistance is a major problem in public health due to the possibility in therapeutic failure. The primary objective of this meeting is to bring together researchers involved in antibiotic resistance prevention and control. The meeting will take an integrated approach to research and it will bring about researchers specializing in different subjects related to antibiotic resistance. We expected to present a universal vision of the importance of antimicrobial resistance in different ecosystems and what can be done about it.
Abstract submission deadline:
31 Jan 2024
Event listing ID:
1570597
Event website:
10
10th Eilat International Educational Course: Pharmacological Treatment of Epilepsy
15 Sep 2024 - 20 Sep 2024 • Jerusalem, Israel
Organizer:
ILAE-Europe
Abstract:
The Course is held under the auspices of the ILAE Europe. The program is designed for junior researchers and clinicians (45 years and younger) working in the field of epilepsy treatment and related basic research. It is open to young neurologists, neuropediatricians, pharmacists, pharmacologists, neuropsychologists and neuroscientists. We are happy to inform you that a number of bursaries have been made available towards partially defraying the cost of accommodation expenses of bursary recipients, who will also have their registration fees waived.
Contact:
Target Conferences Ltd.;     Phone: [+972 3 517 5150];     Email: eilatedu@target-conferences.com
Topics:
Eilat, epilepsy, course, education, treatment, drugs, pharma, pharmacological, international, research
Event listing ID:
1587752
Related subject(s):
Event website:
11
Cleaning Validation Summit 2024
01 Oct 2024 - 02 Oct 2024 • Prague, Czech Republic
Organizer:
Uventia Global
Abstract:
In order to avoid contamination of the product, robust cleaning procedures must be performed. Our online meeting facilitates peers’ reflection and discussion on approaches to establishing and revising CV programs to meet regulatory requirements, verifying CV protocols and preventing ineffective or incorrect approaches to cleaning validation programs, risk based cleaning validation, selecting the right equipment/cleaning procedure combinations, testing for API residues and calculating residue limits, considerations on combining cleaning and sanitization, finding and developing practical analytical methods and sampling procedures.
Contact:
Email: info@uventia.com
Topics:
QRM, Cleaning Validation, Containment, Bioprocessing, Bioproduction, Aseptic, GMP, Regulatory Affairs, Quality Assurance, QA, Risk Management
Event listing ID:
1618712
12
Biomarkers US 2024
28 Oct 2024 - 29 Oct 2024 • San Diego, California, United States
Organizer:
Oxford Global Conferences
Abstract:
Discover the latest advancements in biomarkers at the 8th Annual Biomarker & Precision Medicine US Congress. Join experts from global pharma, top biotechs, and renowned academic institutions to delve into emerging tools and strategies in translational science, diagnostics, and biomarker development.
Contact:
Marketing Executive;     Email: l.staplehurst@oxfordglobal.com
Topics:
Novel Biomarker Discovery, Identification & Characterization, Effective Clinical Biomarker Strategies, Multi-Omics For Precision Medicine, Emerging Strategies For Biomarker Validation & Data Analysis, High-Quality Biospecimens in Clinical Development & Precision Medicine, Innovative Tools & Technologies For Next-Gen Diagnostics
Event listing ID:
1616108
13
International Pharma Congress
18 Nov 2024 - 19 Nov 2024 • Dubai, United Arab Emirates
Organizer:
Noveltics Group LLC
Abstract:
Welcome to the forefront of pharmaceutical innovation! Noveltics Group is thrilled to invite you to the International Pharma Congress which is going to be held during November 18-19, 2024 at Dubai, UAE , where groundbreaking discoveries, transformative technologies, and visionary leaders converge to shape the future of healthcare.
Contact:
Phone: [ +1-765-545-2593];     Email: advancedpharma@researcherstalk.com
Topics:
Pharmacology, Drug Discover, Drug Development, Pharmaceutical Chemistry, Pharmacognosy, Natural Products, Medicinal Plants
Event listing ID:
1610992
14
IECV 2024 — The 2nd International Electronic Conference on Vaccines
27 Nov 2024 - 29 Nov 2024 • online, Switzerland
Organizer:
MDPI
Abstract:
The IECV 2024 invites researchers from academia, as well as vaccine practitioners, to contribute original findings, novel ideas, scientific concepts, and new technologies and experiences to deal with immunology mechanisms, animal models for immunologic diseases, viral immunology, immunopathogenesis, vaccine development and efficacy evaluation, immune responses to vaccines, vaccine technology, vaccine vectors, adjuvants, and immunomodulators.
Contact:
Email: iecv2024@mdpi.com
Topics:
Immunology Mechanisms, Animal Models for Immunologic Diseases, Viral Immunology, Immunopathogenesis, Vaccine Development and Efficacy Evaluation, Immune Responses to Vaccines, Vaccine Technology, Vaccine Vectors Adjuvants and Immunomodulators
Event listing ID:
1614937


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Last updated: 12 May 2024