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

Submit a meeting

Select a location:
Germany (1) - India (1) - Ukraine (1) - United Kingdom (4) - United States (23) - ALL COUNTRIES (30)

1
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:
926578
2
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:
932104
Related subject(s):
3
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:
936105
4
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:
936060
5
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:
936136
6
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:
936168
7
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:
936178
8
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:
936100
9
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:
936176
10
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:
936197
11
Developing a Strategic Approach to FDA Compliance for Computer System Validation
17 Oct 2017 • Aurora, United States
Abstract:
This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. We will discuss the phases within the SDLC, and how these form the basis for any CSV project. The importance of the sequence of steps will also be covered.
Contact:
Training Doyens;     Phone: [7209961616];     Email: support@trainingdoyens.com
Topics:
eu food packaging regulations, eu labeling regulations, eu labeling requirements, eu labelling regulations, eu regulations food labelling
Event listing ID:
948568
Event website:
12
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:
936174
13
A Legal Compliance Program When Billing Durable Medical Equipment
19 Oct 2017 • Aurora, United States
Abstract:
Learn that treating your Medicare patients with Durable Medical Equipment can be great for patient clinical outcomes, a great revenue stream and can be legally compliant. It will also lower healthcare costs. However one must know how to get the proper licensure and know the Federal & State Guidelines.
Contact:
Training Doyens;     Phone: [7209961616];     Email: support@trainingdoyens.com
Topics:
medical device training programs, medical equipment repair course, medical equipment repair training, medical equipment training
Event listing ID:
948155
Event website:
14
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:
936228
15
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:
936205
16
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:
913819
17
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:
936182
18
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:
932171
Related subject(s):
19
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
20
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):
21
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:
932268
Related subject(s):
22
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:
912867
23
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

View all listed conferences in the United States (USA).



Conference-Service.com offers, as part of its business activities, a directory of upcoming scientific and technical meetings. The calendar is published for the convenience of conference participants and we strive to support conference organisers who need to publish their upcoming events. Although great care is being taken to ensure the correctness of all entries, we cannot accept any liability that may arise from the presence, absence or incorrectness of any particular information on this website. Always check with the meeting organiser before making arrangements to participate in an event!

Last updated: 22 September 2017