Meetings/Workshops on Regulation in Medicine and Pharmacology in the United States (USA)

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1
FDA's New Import Program for 2017 - Strict Precision
22 Jun 2017 - 23 Jun 2017 • San Francisco, United States
Abstract:
The FDA continues to change its import program to better manage new problems and to use new procedures to make the whole process easier. The FDA and U.S. Customs and Border Protection (CBP) are relying more and more on computer programs to expedite the import process. When and how you use these programs can make a big difference in the net profit derived from even a single shipment. The new Voluntary Qualified Importer Program (VQIP) is one such example. Another example is CBP’s and FDA’s implementation of the Automated Commercial Environment (ACE) program became mandatory for importers in 2016. If you fail to correctly use new import procedures and programs, you will be operating under an expensive disadvantage. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FDA import regulations, FDA’s import legal requirements, U.S. Customs and Border Protection, CBP requirements, FDA warning letter, FDA import program, risk of detention
Event listing ID:
884993
2
Human Factors and Predicate Combination Products
22 Jun 2017 - 23 Jun 2017 • San Francisco, United States
Abstract:
The FDA has placed significant emphasis on the role of Human Factors in the approval of devices used for medical purposes. There are several current guidance documents and new proposed Draft Guidance documents. This seminar will compare these Guidance documents. Additionally, strategic recommendations will be presented on how to implement these requirements into the medical device design, development and approval processes. Finally, Human Factors methods and best practices will be covered that the FDA is requiring.Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
human factors methods and best practices, role of Human Factors in FDA approval process, medical device design, medical device development, device product life cycle
Event listing ID:
903627
Related subject(s):
3
Statistical Analysis for Product Development
12 Jul 2017 - 13 Jul 2017 • San Francisco, United States
Abstract:
This course is designed to help scientists and engineers understand the statistical methods used in process and product development. Variability is part of every process, design of experiments helps to separate systematic variability from special cause variability. You will get a chance to examine the different sources of variability how it relates to analytical method development, process improvement and sample size selection. The concept of experimental budget will be introduced to help you plan the total number of experiments needed. You will also learn to improve process output characteristics including quality, cost, and robustness through generating empirical models of your processes in the fewest experiments possible. This highly interactive course will allow participants the opportunity to develop strategies for analysis of experimental data. The objective is to provide participants with key technical information along with perspectives to enable them to apply the technologies to their own projects and evolve their own statistical methods to support the various stages of product development. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Statistical Analysis, product development, statistical methods, variability, design of experiments, systematic variability, special cause variability, analytical method development, process improvement, experimental budget
Event listing ID:
885036
4
Compliance Risk Management in Medical Devices, Pharmaceuticals, and Combination Products
13 Jul 2017 - 14 Jul 2017 • Minneapolis, United States
Abstract:
Effective risk management is the hallmark of a successful corporation. Increasingly, it is also the hallmark of a compliant corporation. While Medical Devices, Pharmaceuticals, and Combination Products have had unique histories for the evolution of risk management, the management of compliance risk is a common business process for all three areas. Enterprise Risk Management (ERM) is the generic term for managing the risks of an organization. ISO 31000 is the ERM ISO Standard. This standard provides guidance for organizations on implementing ERM solutions. ISO 9001 is the Quality Systeme Standard. ISO 9001 now requires to establish “risk-based thinking.” As a result, ISO 13485, the International Quality System Standard for Medical Devices, has been revised to include requirements for firms to implement Compliance Risk Management. These requirements are in addition to the requirements as currently defined by ISO 14971, the International Standard for Risk Management of Medical Devices.Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Enterprise Risk Management (ERM) Training, ISO 31000, ERM solutions, ISO 14971 Training, medical device risk management training, Compliance Risk Management
Event listing ID:
878105
Related subject(s):
5
Understanding the FDA's Regulation of HCT/Ps and Successful Product Development Strategies
13 Jul 2017 - 14 Jul 2017 • Irvine, United States
Abstract:
In 1997, the FDA proposed a comprehensive regulatory program for Human Cells, Tissues and Cellular- and Tissue-Based Products (HCT/Ps) outlining the registration and listing procedures for HCT/Ps. This program also differentiates between HCT/Ps that will be regulated via the traditional pathway and those that will undergo approval as new drugs, biologics or devices. In this seminar, we'll discuss the historical context for the use of HCT/Ps in medicine as well as how the HCT/P market is evolving. You will be shown examples of the FDA-approved use of HCT/Ps and what is required for successful product development. This course will also provide an overview of the health authority regulating HCT/Ps, discuss the regulations that govern HCT/Ps, discuss potential product development strategies and provide an overview of product development in the United States. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FDA regulatory oversight of HCT/Ps, tissue reference group, approval process, good tissue practice, good manufacturing practice, quality system regulations, good laboratory practice, FDA enforcement actions, adverse event reporting, homologous use, adipose tissue, translation medicine
Event listing ID:
885057
6
Compliance Risk Management in Medical Devices, Pharmaceuticals, and Combination Products
13 Jul 2017 - 14 Jul 2017 • Minneapolis, United States
Abstract:
Effective risk management is the hallmark of a successful corporation. Increasingly, it is also the hallmark of a compliant corporation. While Medical Devices, Pharmaceuticals, and Combination Products have had unique histories for the evolution of risk management, the management of compliance risk is a common business process for all three areas. Enterprise Risk Management (ERM) is the generic term for managing the risks of an organization. ISO 31000 is the ERM ISO Standard. This standard provides guidance for organizations on implementing ERM solutions. ISO 9001 is the Quality Systeme Standard. ISO 9001 now requires to establish “risk-based thinking.” As a result, ISO 13485, the International Quality System Standard for Medical Devices, has been revised to include requirements for firms to implement Compliance Risk Management. These requirements are in addition to the requirements as currently defined by ISO 14971, the International Standard for Risk Management of Medical Devices. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Enterprise Risk Management (ERM) Training, ISO 31000, ERM solutions, ISO 14971 Training, medical device risk management training, Compliance Risk Management
Event listing ID:
885078
7
FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies
13 Jul 2017 - 14 Jul 2017 • Irvine, United States
Abstract:
Stem cells harness the power to differentiate into numerous cells upon stimulation. This has led to their wide exploration across all of medicine, including high risk diseases. Of course, significant scientific breakthroughs in the use of stem cells to prevent, diagnose, and treat numerous diseases has caused numerous start-up companies to form. Despite, such promise, the FDA has yet to approve stem cell therapies for a wide range of diseases, except cord blood-derived hematopoietic progenitor cells for certain indications. This tutorial will provide an historical context for the use of stem cells in medicine, where the field has been and where it is going. It will also provide the few examples of FDA approved use of stem cells in medicine and what is needed for the field to progress. For example, in 2006, the U.S. FDA implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue-based products. Currently, there is an ongoing debate in industry on how such therapies should be regulated, in particular by the FDA or under the practice of medicine, under federal law or state law, and as drugs or simply biologics. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Regenerative medicine regulations, Stem Cell Treatments, biomaterials, FDA regulates regenerative treatments and therapies, good manufacturing, good laboratory practices
Event listing ID:
885077
8
Supplier Management for Medical Device Manufacturers
13 Jul 2017 - 14 Jul 2017 • Cambridge, United States
Abstract:
Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide components to the device manufacturer, which means that they are critical to performance and delivery. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment.Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Supplier management, supplier selection, medical device manufacturers, FDA quality system regulations, ISO 13485 requirements, supplier classification system
Event listing ID:
903636
9
FDA Scrutiny of Promotion and Advertising Practices
13 Jul 2017 - 14 Jul 2017 • San Diego, United States
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
fda's advertising and promotion requirements, fda regulations for labelling, fda warning letter, fda legal authority, ftc, mass media, doj
Event listing ID:
903635
10
ISO 13485, ISO 14971, Quality Document Management, and Risk Management for Medical Devices
17 Jul 2017 - 18 Jul 2017 • Sydney, United States
Abstract:
Medical device manufacturing companies generate a copious number of documents when implementing a Quality and a Regulatory Management System. Various applications are available for purchase but at a high cost and unfortunately with ongoing maintenance license fees and the use of the service provider’s cloud systems which at times becomes questionable with current cybersecurity issues we all face. This session will take through a new paradigm in work practices for managing documentation without the need to continuously search and question obsolescence and relevancy. It will introduce the use of Microsoft Excel and hyperlinks to manage particular areas of document and project management. You will learn how to best manage your documents, remain compliant to ISO 13485 but most importantly eliminate one of the biggest time wasters when documents are saved by one person and retrieved by a different person in your organisation.Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
ISO 13485 training, ISO 13485:2016, document management, risk assessment ISO 14971, risk analysis, quality and regulatory management documentation system
Event listing ID:
903699
11
A Comprehensive View of FDA Regulations for Medical Devices
20 Jul 2017 - 21 Jul 2017 • Cambridge, United States
Abstract:
Don’t let a common misunderstanding get you into trouble! There is more to the US Medical Device Regulations than Part 820. Companies that don’t understand will face regulatory scrutiny and receive FDA Form 483s and Warning Letters. Recently a device manufacturer got a Warning Letter relating to updates to shipped devices, which said, “The Quality Manager stated he was unaware of the corrections and removal reporting and recordkeeping requirements.” Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
US medical device regulations, FDA medical device compliance best practices, FDA QSR, medical device reports (MDR), Unique Device Identification (UDI), Quality System Inspection Technique (QSIT), FDA inspections, medical device manufacturer
Event listing ID:
885054
12
FDA Recalls - Before You Start, and After You Finish
03 Aug 2017 - 04 Aug 2017 • Salt Lake City, United States
Abstract:
FDA's recall authority and program launches you into a project of crisis management. You will learn how to establish a roadmap for conducting recalls. The knowledge you gain will sharpen your recall management decisions and strategy. You will learn how to use the FDA's health risk criteria so you can develop effective recall procedures. One critical aspect of recalls involves the identification of the root cause of the recall and how you could or should prevent that problem from happening again. Your corrective and preventive action program (CAPA) and quality assurance functions require a rigorous approach to prevent a chronic history of recalls. Reiterative recalls lead the FDA to the conclusion that,
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FDA Recall, FDA recall classes, FDA recall guidance, FDA recall procedures, regulatory management, CAPA, FDA inspection, Recall Regulations, Mandatory recall actions
Event listing ID:
885064
13
How to prepare a 510(k) Notification and a Technical File for the CE Mark
03 Aug 2017 - 04 Aug 2017 • San Diego, United States
Abstract:
For a new or modified medical device, product approvals are required prior to distribution. This course is intended to provide participants with a detailed list of documents and testing required for a 510(k) Notification submission to the US FDA and a Technical File for submission to a Notified Body for the CE Mark. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FDA refuse to accept policy, special 510(k) submissions, traditional, 510(k) submissions
Event listing ID:
914007
14
Sample Size Justification & Statistical Analysis for Performance Qualification (PQ) Studies
17 Aug 2017 - 18 Aug 2017 • San Francisco, United States
Abstract:
Regulatory agencies mandate formal protocols for Performance Qualification (PQ) studies to determine whether products/processes meet the desired requirements. When planning PQ studies, sample size determination is critical to ensure that study results will be meaningful. Methods to determine appropriate sample sizes for various types of problems will be covered. This 2-day seminar will provide a 12-step process to assist you in writing/reviewing protocols for PQ studies with a focus on sample size justification, acceptance criteria and statistical analysis using Minitab v17. Validation of software will not be covered. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
statistical analysis for performance qualification (PQ) Studies, protocols for performance qualification (PQ), size justification
Event listing ID:
916139
15
FDA 510(k) Submissions — 510(k) Submissions to the FDA: Hands-On Workshop
24 Aug 2017 - 25 Aug 2017 • Chicago, United States
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. 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.
Contact:
Peter Brown;     Phone: [410-501-5777];     Email: pbrown@fdamap.com
Topics:
FDA 510(k) Seminar, 510(k) submission, FDA 510(k) Clearance, 510(k) Regulations, FDA 510(k) Workshop, 510(k) Application, 510(k) Strategy, , 510(k) Listing, , 510(k) Filing, 510(k) Approval, Class 1 and 2 Medical Device
Event listing ID:
911425
16
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
24 Aug 2017 - 25 Aug 2017 • San Francisco, United States
Abstract:
The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
eCTD submission workshop, FDA eCTD submission training, CTD/eCTD format requirements, eCTD submission technical & document requirements
Event listing ID:
913973
Related subject(s):
17
Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)
24 Aug 2017 - 25 Aug 2017 • Philadelphia, United States
Abstract:
This two-day comprehensive Course on Latin America Regulatory compliance requirements will cover topics ranging from pre-clinical and clinical requirements through product registration, amendments and renewals across Pharmaceuticals, Biologics, Medical Devices and Combination Products. The Course will address the structure of the regulatory agencies in Latin America and discuss local cultural nuances to help you be successful in working with the regulators. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Latin America regulations, Latin America life sciences regulations, Latin America pharmaceutical regulations
Event listing ID:
916061
18
Basic Compliance Academy
11 Sep 2017 - 14 Sep 2017 • Philadelphia, PA, United States
Abstract:
HCCA's Basic Compliance Academy is a three-and-a-half-day intensive training program focusing on subject areas at the heart of health care compliance practice. Its faculty is made up of experts in the field. Courses are designed for participants who have a basic knowledge of compliance concepts and some professional experience in a compliance function.
Contact:
HEALTH CARE COMPLIANCE ASSOCIATION;     Phone: [service@hcca-info.org];     Email: 888-580-8373
Topics:
Policies, Procedures and Infrastructure, Corporate Responsibility, Risk assessment, Education and Training, Routine Auditing and Monitoring, Stark and Anti-Kickback, HIPAA Privacy and Security, Conflicts, Discipline & Incentives
Event listing ID:
913751
19
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
12 Sep 2017 - 13 Sep 2017 • Boston, United States
Abstract:
Analytical methods and procedures should be validated to ensure reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing. In case a laboratory wants to use an alternative method instead of a compendial method, equivalency of the alternative method to the compendial method should be demonstrated. Method validation recently got highest attention from regulatory agencies and industry task forces. For example, FDA and EMA released guidelines on method validation and transfer, and USP has proposed new approaches chapters for integrated validation, verification and transfer of analytical procedures, for equivalency testing and for statistical evaluation. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Laboratory compliance, Analytical methods, data, procedures, compendial methods, Method validation and transfer, equivalency testing, FDA inspection, SOPs, FDA and EU compliance
Event listing ID:
885063
20
FDA's Medical Device Software Regulation Strategy
21 Sep 2017 - 22 Sep 2017 • Boston, United States
Abstract:
The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Seminar by Ex-FDA Official, Regulatory profile for software products, FDA mobile apps regulation, medical device software functionality, FDA and NIST software guidance
Event listing ID:
885128
21
22nd International Conference of FFC- Functional Foods and Chronic Diseases: Science and Practice
22 Sep 2017 - 23 Sep 2017 • Boston, United States
Abstract:
Functional Food Center is pleased to announce its 22nd International Conference
Contact:
Email: ffc@functionalfoodcenter.com
Topics:
functional foods, chronic diseases, diabetes, CVD, obesity, cancer
Event listing ID:
876657
22
Healthcare Enforcement Compliance Institute
29 Oct 2017 - 01 Nov 2017 • Washington, DC, United States
Abstract:
Learn best and leading-edge practices for those involved in regulatory compliance at the Healthcare Enforcement Compliance Institute. The conference education will go beyond legal analysis to implementing systems to ensure the law is followed. You will be provided practical advice from lawyers and compliance officers in an interactive forum that facilitates greater collaboration between the legal and compliance teams. Get the latest legal analysis of various regulations and learn what you need to do to ensure you're in compliance with all the regulations and working most efficiently. Discover and discuss the latest trends in regulatory changes. Learn from experts focused not on legal discussions but dedicated to sharing the latest and best practices for implementing an effective compliance program that finds and fixes problems. Attend sessions focused on False Claims Act, Kickback, Stark Law, Criminal Healthcare Fraud and Internal Investigations.
Contact:
HEALTH CARE COMPLIANCE ASSOCIATION;     Phone: [888-580-8373];     Email: service@hcca-info.org
Topics:
False Claims Act, Kickback and Stark Law, Hospice and Nursing Homes, Criminal Healthcare Fraud, Compliance Program, Internal Investigations
Event listing ID:
913808
23
Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices
09 Nov 2017 - 10 Nov 2017 • Cambridge, United States
Abstract:
Federal regulation of the advertising and promotion of pharmaceuticals and medical devices reflects an aggressive attitude on the part of the regulators that demands, in turn, that industry be keenly aware of the legal and regulatory duties, as well as key recent trends in enforcement activities by the Federal Government. This course will explore in detail what FDA requires of drug and device firms as well as recent current hot buttons in FDA enforcement activity for the advertising arena. What’s at stake if your advertising and promotional efforts violate the law? Colossal fines – the latest was $3 Billion; criminal liability, including even prison time; and huge disruption in operations while dealing with federal probes into illegal marketing. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FDA training seminar, FTC advertising seminar, advertising drugs, advertising medical devices, promotion drugs, promoting medical devices, FTC advertising rules
Event listing ID:
885138
24
Biosimilars North America — 4th Annual Biosimilars North America Conference
15 Nov 2017 - 16 Nov 2017 • Iselin, United States
Abstract:
The market for biosimilars in North America continues to grow and has become highly lucrative. As such, pharmaceutical companies continue to find ways to differentiate their products in such a saturated market. Thus, Biosimilars North America 2017 will provide an intelligent meeting to explore novel and innovative strategies to advance biosimilar development, and ensure optimal market access and commercialization opportunities whilst complying with evolving regulatory requirements. This year, the conference will also explore significant developmental topics within the sector including the impact of FDA’s newly implemented biosimilar interchangeability guidelines, the US market access landscape, and biosimilars of orphan drugs.
Contact:
Honey de Gracia;     Phone: [02078276102];     Email: hdegracia@smi-online.co.uk
Topics:
Biosimilars, Interchangeability, Innovator, biosimilar commercialization, Immunogenicity, Pricing, Market Growth, generics, biosimilar market, biogenerics, biosimilar interchangeability guide, FDA, regulatory updates, drug development, biobetters, drug discovery, drug design,
Event listing ID:
912801
25
SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations
07 Dec 2017 - 08 Dec 2017 • Research Triangle, United States
Abstract:
One of the best ways to ensure that an organization meets its regulatory obligations is to follow SOPs. SOPs are standardized procedures and processes prepared with enough detail to ensure that tasks are performed consistently each time they are done. SOPs are also required to be in compliance with regulations and guidelines internationally, across all regulated functions. Lack of SOPs and not following SOPs are often cited in regulatory inspections as deficiencies that must be corrected. Poorly prepared SOPs or poor compliance with existing SOPs can compromise a drug development program, an effective quality system, and may result in product recalls. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FDA SOP requirements, FDA SOPs, FDA regulated industry SOP types, FDA SOP components, SOP training, SOP implementation, SOP template
Event listing ID:
914049

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