Conferences  >  Medicine & Healthcare  >  Regulation in Medicine and Pharmacology  >  United States

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1
Healthcare Basic Compliance Academy
03 Apr 2023 - 06 Apr 2023 • Nashville, TN , United States
Organizer:
Health Care Compliance Association (HCCA)
Event listing ID:
1526211
2
27th Annual Compliance Institute
23 Apr 2023 - 26 Apr 2023 • Anaheim, CA, United States
Organizer:
Health Care Compliance Association (HCCA)
Event listing ID:
1526298
3
Healthcare Basic Compliance Academy
08 May 2023 - 11 May 2023 • Chicago, IL, United States
Organizer:
Health Care Compliance Association (HCCA)
Event listing ID:
1526253
4
Healthcare Privacy Compliance Academy
08 May 2023 - 11 May 2023 • Chicago, IL, United States
Organizer:
Health Care Compliance Association (HCCA)
Event listing ID:
1526296
5
510(k) Submissions to the FDA: Hands-On Workshop
11 May 2023 - 12 May 2023 • online , 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 #510k #510k Submission #510k Writers #FDA Compliance #FDA Regulations
Event listing ID:
1550475
6
Healthcare Compliance Essentials Workshop
15 May 2023 - 18 May 2023 • Virtual, United States
Organizer:
Health Care Compliance Association (HCCA)
Event listing ID:
1526284
7
PEGS Boston Conference & Expo
15 May 2023 - 19 May 2023 • Boston, United States
Organizer:
Cambridge healthtech Institute
Abstract:
Experience the Future of Biotherapeutic Drug Development Welcome to PEGS Boston The world’s largest gathering of protein engineering and biotherapeutics experts is back in Boston! PEGS Boston Summit is the leading biologics event with comprehensive programming covering all aspects of biologic drug development with in-depth presentations on protein and antibody engineering, immunotherapy, oncology, expression, analytics, immunogenicity, and more. Harness the power of in-person events, form genuine connections, create valuable relationships with peers, and become part of the PEGS community.
Contact:
Cambridge healthtech Institute;     Phone: [7819725400];     Email: reg@healthtech.com
Topics:
Academic Research, Analytical Research, Big Data, Biochemical, Bioengineering, Bioinformatic, Biological Science, Biomedicine, Bioprocessing, Biopsy, Biosciences, Biotech, Biotechnology, Cancer Research, Cell, Data, Data Management, Data Science, Discovery, Diseases, Disorders, Drug, Expo, Gene, Health, Health & Medicine, Healthcare, Manufacturers, Medical, Medical Science, Medicine, Research, research symposium, Science, Science and Technology, Scientific, Stem Cell, Tissue Repair,
Event listing ID:
1539419
8
New Orleans Regional Healthcare Compliance Conference
19 May 2023 • Virtual, United States
Organizer:
Health Care Compliance Association (HCCA)
Event listing ID:
1526327
9
Research Compliance Conference
11 Jun 2023 - 13 Jun 2023 • Phoenix, AZ, United States
Organizer:
Health Care Compliance Association (HCCA)
Event listing ID:
1526337
10
SCCE's Creating Effective Compliance Training
21 Jun 2023 - 22 Jun 2023 • Virtual, United States
Organizer:
Health Care Compliance Association (HCCA)
Event listing ID:
1526336
11
Healthcare Basic Compliance Academy
24 Jul 2023 - 27 Jul 2023 • New Orleans, LA, United States
Organizer:
Health Care Compliance Association (HCCA)
Event listing ID:
1526357
12
Healthcare Basic Compliance Academy
21 Aug 2023 - 24 Aug 2023 • Washington, DC, United States
Organizer:
Health Care Compliance Association (HCCA)
Event listing ID:
1526378
13
Healthcare Privacy Compliance Academy
21 Aug 2023 - 24 Aug 2023 • Washington, DC, United States
Organizer:
Health Care Compliance Association (HCCA)
Event listing ID:
1526355
14
Healthcare Compliance Essentials Workshop
18 Sep 2023 - 21 Sep 2023 • Virtual, United States
Organizer:
Health Care Compliance Association (HCCA)
Event listing ID:
1526354
15
Healthcare Compliance Essentials Workshop
04 Dec 2023 - 07 Dec 2023 • Virtual, United States
Organizer:
Health Care Compliance Association (HCCA)
Event listing ID:
1526364


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Last updated: 25 March 2023