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

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1
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:
911403
2
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:
914017
Related subject(s):
3
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:
916050
4
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:
913806
5
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:
885041
6
Analytical Instrument Qualification and System Validation
14 Sep 2017 - 15 Sep 2017 • Cambridge, United States
Abstract:
Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations. This 2-day course provides the regulatory background and guides attendees through the complete equipment qualification, calibration and computer system validation processes from planning to reporting. It also helps to fully understand Part 11 and Annex 11 requirements to ensure and document integrity and other requirements for electronic records and signatures. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Analytical Instrument Qualification, system validation process, operational qualification, instrument qualification, validation planning
Event listing ID:
926569
7
Root Cause Analysis and CAPA using 8-D Problem Solving Method
14 Sep 2017 - 15 Sep 2017 • San Francisco, United States
Abstract:
Errors and defects are a problem in virtually every industry. The goal of defect-free/error-free product or service delivery is the aim of every company. However, in order to eliminate defects or errors permanently, you must use a disciplined approach in order to ensure that the problem does not recur. One of the most widely-used tools is the 8 Disciplines (8D) methodology. 8D requires you to identify and fix the problem immediately (put a bandaid on it) while identifying the Root Cause(s), and take steps to address the problem in the short term as well as in the long term (permanent fix). In this interactive workshop, you’ll learn how to apply the many tools used to identify possible causes, determine (with data) which is the true root cause (or causes, as there may be some compounding of problems occurring), and how to fix them – permanently. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
8-D Reporting, Reporting and Problem-Solving Technique, Root Cause Analysis, 8 Disciplines (8D) method, 8D framework, 8D technique, Root Cause Analysis (RCA)
Event listing ID:
926535
8
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:
885106
9
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:
876591
10
FDA Audit, Quality Assurance Practices, Responsibilities and Expectations
28 Sep 2017 - 29 Sep 2017 • New Jersey, United States
Abstract:
It is no surprise to anyone who reviews regulatory citations to notice the number of deficiencies cited that are associated with quality systems. Today, the basis for all FDA audits both within the US and internationally is based on the quality systems approach and the six systems that comprise it. Whether the audit is a full or partial audit, the quality system within a company will always be inspected and this seminar will help review what are the expectations and the common areas to be familiar with. As a basis for regulatory audits, the quality system, its procedures and their implementation are reviewed to help verify the level of effectiveness in assuring consistent control and quality of materials, components and final product. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FDA audit seminar, quality assurance practices, internal audit, vendor audit, third party audit, regulatory audit, CAPA programs
Event listing ID:
926501
11
Exploring Data Integrity To Include FDA, WHO and EMA's Latest Guidance for Industry (2015/2016)
02 Oct 2017 - 03 Oct 2017 • Oakland, United States
Abstract:
Data Integrity has become a non-compliance area often observed by the FDA and reported within Form FDA 483s and Warning Letters. While various governments have observed this on a world-wide basis, the FDA has been reporting its occurrence off-shore with a greater frequency than usually observed within the United States. A lack of Data Integrity hints of a Company being outside of compliance and questions the quality of the product being produced.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Event listing ID:
932093
Related subject(s):
12
GLP Comparison with GMP in Quality System -2017
04 Oct 2017 • online, United States
Abstract:
Good Laboratory Practice (GLP) is a quality system which intend for non-clinical studies and was revised by several bodies. GLP is a unique quality system in the sense it is intend for non-routine processes and activities.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
Veterinary Companies, Study Directors, Laboratory Managers
Event listing ID:
936138
13
What are Standards for Medical Device Software -2017
10 Oct 2017 • online, United States
Abstract:
With various changes to standards and regulations, it is important to understand the criteria for compliance, this is your DIY guide to the changes in standards, specifically covering the IEC 62304 standard.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
Business Analysts, Requirements Analysts, Product Managers
Event listing ID:
936159
14
Laboratory Have an Instrument Calibration Program -2017
10 Oct 2017 • online, United States
Abstract:
This web seminar builds on the terminology found in 21CFR160(b)(4) and introduces terminology and concepts not found in the regulation, but necessary for an effective calibration program, such as instrument classifications.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
Laboratory Managers, Laboratory Supervisors, Laboratory Analysts, Quality Assurance Managers
Event listing ID:
936103
15
Compliance for Computer Systems Regulated by FDA - 2017
10 Oct 2017 • online, United States
Abstract:
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
Analytical Chemists, Laboratory Managers, Automation Analysts
Event listing ID:
936091
16
Cybersecurity and Computer Systems Validation - 2017
11 Oct 2017 • online, United States
Abstract:
Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
Validation Engineers, Validation Project Managers, Program/Project Managers
Event listing ID:
936167
17
Batch Record Review and Product Release - 2017
13 Oct 2017 • online, United States
Abstract:
A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
Quality Assurance, Batch Record Reviewers, Production Personnel
Event listing ID:
936199
18
Medical Device Engineering Change Control - 2017
17 Oct 2017 • online, United States
Abstract:
This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process. It will be compliant but not cumbersome or overly time consuming. The difference between pre release and post release change control will be explained.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
QA/ QC Personnel, Engineering Management, Regulatory Personnel
Event listing ID:
936143
19
Analytical Instrument Qualification and Validation Processes - 2017
17 Oct 2017 • online, United States
Abstract:
In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
Process Owners, Quality Engineers, Quality Auditors
Event listing ID:
936153
20
How to Develop the Risk Management File - 2017
18 Oct 2017 • online, United States
Abstract:
The single most important element of medical device risk management is the Risk Management Plan (RMP). It ranges from Top Management's risk policy to review and approval of the Risk Management Report. Get these items wrong and the rest of your risk management process will suffer.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
Top Management, R&D Managers, Risk Managers
Event listing ID:
936152
21
483 Covers a Broad Gradation of Problems
25 Oct 2017 • online, United States
Abstract:
How you respond to the 483 should provide the foundation for any future communication with the FDA about a particular inspection. Understanding how FDA organizes its evaluation of the 483 can facilitate the FDA’s review in your favor as it is well organized, succinct and provides proper documentation.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
Manufacturers, FDA Consultants, Legal Counsel
Event listing ID:
936217
22
NIST Cybersecurity Framework For Computer Systems Validation
25 Oct 2017 • online, United States
Abstract:
Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
Validation Engineers, Validation Project Managers, Program/Project Managers
Event listing ID:
936249
23
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:
913764
24
Guidance on Software and Device Changes and the 510(k)
30 Oct 2017 • online, United States
Abstract:
The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
Compliance Managers and Auditors, Lab Managers and Analysts, Automation Analysts
Event listing ID:
936259
25
Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations (Updated to address recent Homeopathic Drug announcements by FDA & FTC)
07 Nov 2017 - 08 Nov 2017 • San Francisco, United States
Abstract:
This interactive one-and-a-half-day seminar is intended to educate regulatory and quality professionals regarding the rather complicated regulations that distinguish Non-prescription Drugs from other products such as foods, cosmetics, dietary supplements and prescription drugs that sometimes contain the same ingredients. Recent FDA actions such as the banning of antibacterial soaps and ongoing programs that may impact manufacturers and private label distributors will be discussed. It will explain differences in the way homeopathic and conventional drugs are regulated and update participants on FDA’s application of GMP regulations to manufacturing low risk drugs that could be sold as cosmetics with the same ingredients, but different labeling. Note: Use coupon code REFERRAL10 and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Cosmeceuticals, dietary supplements, cosmetics, homeopathic OTCs, FDA regulations, FDA GMPS, good manufacturing practices
Event listing ID:
932226
Related subject(s):
26
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:
885105
27
Quality Control Laboratory Compliance - cGMPs and GLPs
09 Nov 2017 - 10 Nov 2017 • San Francisco, United States
Abstract:
FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries - pharmaceuticals, biologics, medical devices, as well as foods and cosmetics - as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals. This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions. In addition, this course will include a list of relevant regulations and guidelines and demonstrate how quality control and quality assurance personnel can monitor industry practices to stay “current” with FDA requirements (cGMPs and GLPs). Note: Use coupon code REFERRAL10 and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Quality Control Lab regulations, QC Lab regulations, FDA QC Lab requirements, FDA lab regulations, Good Laboratory Practices
Event listing ID:
932236
Related subject(s):
28
PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation
09 Nov 2017 - 10 Nov 2017 • San Francisco, United States
Abstract:
The European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine its effectiveness. It includes audit of the pharmacovigilance system which is covered by the quality system. The GVP Modules are applicable to EU-based companies and any company marketing medicinal products on a global basis. The legally required risk based audit strategy shall cover all PV processes and tasks undertaken by or delegated to other departments, MAH affiliates, and third parties such as distributors, external service providers, partners (the PV Universe). The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule. Note: Use coupon code REFERRAL10 and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
PV Audit Strategy Planning, The European Medicines Agency's (EMA) Guideline, Good Pharmacovigilance Practices (GVP), risk-based audits
Event listing ID:
932202
Related subject(s):
29
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
30
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:
914005

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Last updated: 10 August 2017