Online Training, Webinars in the United States (USA)

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1
Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies
01 Mar 2021 - 02 Mar 2021 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
This program combines general considerations for Good Manufacturing Practice (GMP) compliance management with the principles of phase-appropriate GMP considerations, with an emphasis on needs of virtual companies. (“Virtual companies” are those who outsource GMP operations to Contract Manufacturing Organizations (CMOs) and Contract Analytical Laboratories.)
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
phase appropriate gmp, fda gmp workshop, FDA GMP Expectations, Phase I, First-in-Man Clinical Trials, CMC Requirements, IND Study, Raw Material Management, 505(b)(2) Products process Validation, ISO 9001:2015 QMS, Combination Products
Event listing ID:
1409948
2
Mobile Apps as Medial Devices
02 Mar 2021 • Fremont – online, United States
Organizer:
S2mtrainings
Contact:
Event Manager;     Phone: [1-800-447-9407];     Email: s2mtraining18@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410729
Related subject(s):
3
HIPAA Waivers during COVID-19
02 Mar 2021 • Fremont – online, United States
Organizer:
S2mtrainings
Contact:
Event Manager;     Phone: [1-800-447-9407];     Email: s2mtraining18@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410684
Related subject(s):
4
Are You Ready for FDA FSMA Preventive Controls Audit Post COVID?
02 Mar 2021 • Fremont – online, United States
Organizer:
S2mtrainings
Contact:
Event Manager;     Phone: [1-800-447-9407];     Email: s2mtraining18@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410672
5
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
03 Mar 2021 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
Excel Spreadsheet Validation, 21 CFR Part 11 Compliance, Develop and Validate Excel Spreadsheets, GxP compliant Excel spreadsheets, Excel for audit trails, spreadsheet security features, data entry verification
Event listing ID:
1409800
6
Patient Access of Health Information - Follow the Rules or Risk Enforcement Penalties
03 Mar 2021 • Fremont – online, United States
Organizer:
S2mtrainings
Contact:
Event Manager;     Phone: [1-800-447-9407];     Email: s2mtraining18@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410693
Related subject(s):
7
Designing and Sustaining New and Existing Product Stability Testing Program
03 Mar 2021 - 04 Mar 2021 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
This Virtual Seminar will provide a great resource to Pharmaceutical, Biotechnology, Diagnostics, Cell Therapy, Drugs, Biologics, OTC, Radio-pharmaceutical, Pharmacies and Medical Device Industries in understanding the effective way to establish a new or modified product stability testing program. This program is an important part of a product's regulatory filing requirements as well as the determination of the shelf life or expiration date of the product
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
fda drug stability testing program, drug product stability testing, ich drug product stability, product stability test, fda drug product stability guidance, stability studies, analyzing stability data, stability protocols and schedules
Event listing ID:
1409870
8
Risk Management in Medical Devices Industry
03 Mar 2021 - 04 Mar 2021 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
Risk management is a mandatory and necessary process during the entire device life. Not only will it help to design and maintain devices efficiently, but it also ensures that the device will be as safe as possible and prevents harm to patients, users, and the environment.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
medical device risk management training, ISO 14971 workshop, ISO 13485, quality system integration, IEC62304, IEC62366-1/-2, risk management life cycle, FDA software reviewers' guidance, SOP framework, risk rating methods, european special requirements, risk management report
Event listing ID:
1409935
9
Care Coordination: A Fundamental Role for Managing Cost and Length of Stay
08 Mar 2021 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
In this care coordination training you will learn how to apply the key strategies for reducing your hospital’s cost and length of stay. Also you will learn how to appreciate the role of interdisciplinary care rounds by identifying your hospital’s strength and weakness related to care coordination.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
care coordination in healthcare, care coordination in hospital, care coordination in nursing, care coordination strategies, care coordination training, care coordination program
Event listing ID:
1409887
10
Effective Standard Operating Procedure (SOPs) Development
09 Mar 2021 • Fremont – online, United States
Organizer:
Panelcompliance
Contact:
Event Manager;     Phone: [1-800-447-9407];     Email: panelcompliance@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410637
11
Medical Device Complaints & CAPA
09 Mar 2021 • Fremont – online, United States
Organizer:
Panelcompliance
Contact:
Event Manager;     Phone: [1-800-447-9407];     Email: panelcompliance@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410658
12
Project Management in Healthcare
09 Mar 2021 • Fremont – online, United States
Organizer:
S2mtrainings
Contact:
Event Manager;     Phone: [1-800-447-9407];     Email: s2mtraining18@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410692
13
Marketing to Medicare or Medicaid Beneficiaries - What You Can and Cannot Do
10 Mar 2021 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
This webinar will review not only the Anti-Kickback Statute and its safe harbors, but will provide an in-depth overview of OIG guidance and advisory opinions dealing with marketing activities, as well as a review of case law regarding marketing behavior.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
Anti-Kickback, Medicare, Medicaid, OIG advisory, OIG compliance, OIG, DME provider, Civil Monetary Penalties, hospital, physician practice
Event listing ID:
1409886
14
How to Prepare a Standard Operating Procedure (SOP)?
10 Mar 2021 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
sop, sop training, standard operating procedure
Event listing ID:
1409830
15
COVID-19 Legislation and Tax credits
10 Mar 2021 • Fremont – online, United States
Organizer:
Hrtrainonline
Contact:
Event Manager;     Phone: [1-800-385-1627];     Email: hrtrainonline@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410490
16
Rules for Managing Disclosure of Substance Use Disorder Information
10 Mar 2021 • Fremont – online, United States
Organizer:
Webinarhealth
Contact:
Event Manager;     Phone: [1-800-385-1607];     Email: webinarhealth@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410619
Related subject(s):
17
6-Hour Virtual Seminar on The New EU Medical Device Regulation
10 Mar 2021 • Fremont – online, United States
Organizer:
Vctrainings
Contact:
Event Manager;     Phone: [1-800-447-9407];     Email: vctrainings2020@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410677
18
Taking Care of You - Managing Stress, Mental Health and Self Esteem
10 Mar 2021 • Fremont – online, United States
Organizer:
S2mtrainings
Contact:
Event Manager;     Phone: [1-800-447-9407];     Email: s2mtraining18@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410691
19
Lifecycle Management of Analytical Methods and Procedures according to new USP and ICH Guidelines
11 Mar 2021 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
Managing analytical methods and procedures according to the lifecycle approach has been recommended in recent FDA guidance documents and stimuli articles published by the USP. For example, the recent FDA guidance “Analytical Procedures and Methods Validation for Drugs and Biologics” contains a section on Lifecycle Management of Analytical Procedures.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
Analytical Instrument Qualification, USP General Chapter 1058, instrument qualification lifecycle, analytical method lifecycle management, analytical lifecycle management presentation, analytical life cycle, model lifecycle management, usp analytical method
Event listing ID:
1409901
20
COVID-19 - Working Remotely for Business Continuity
11 Mar 2021 • Fremont – online, United States
Organizer:
S2mtrainings
Contact:
Event Manager;     Phone: [1-800-447-9407];     Email: s2mtraining18@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410778
21
Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada
11 Mar 2021 - 12 Mar 2021 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
In-vitro Diagnostics (IVD) products provide critical information on patient’s health condition, based on which the healthcare provider develops and administers treatment plan. Although IVDs are medical devices, they are regulated under a separate set of regulations in U.S., Europe, and Canada.

This 2 day interactive course on in-vitro diagnostics is structured to understand the different set of IVD regulations, how to navigate through this maze of IVD regulations, and to win regulatory approvals. This In-vitro Diagnostics (IVD ) course will make the attendees understand the IVD regulations and develop regulatory strategies that secure regulatory approvals.

Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
In-vitro Diagnostics, IVD regulations, European IVD regulations, Canadian IVD requirements, US in-vitro diagnostic regulations, IVD labeling requirements, Canadian medical device regulations, content of 510(k), Pre-IDE, IDE and PMA
Event listing ID:
1409988
22
Implementing a Robust Data Integrity Program
12 Mar 2021 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
This webinar will detail a data integrity governance program and principles for defining quality and data integrity into processes and systems. It will cover the common problems from FDA 483 observations and warning letters and teach you how to avoid them.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
Fda data integrity guidance final, data integrity and compliance, fda data integrity audit, FDA (CFR) data integrity guidance, EurdraLex data integrity guidance review, PIC/S data integrity guidance, Protecting electronic records of standalone systems, Audit trail, data integrity access control, data integrity program, data integrity definition
Event listing ID:
1409939
23
Are You Prepared? How to Keep Remote Engagement During COVID 19 Crisis
12 Mar 2021 • Fremont – online, United States
Organizer:
Hrtrainonline
Contact:
Event Manager;     Phone: [1-800-385-1627];     Email: hrtrainonline@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410544
24
COVID-19 - HR Compliance Risks
12 Mar 2021 • Fremont – online, United States
Organizer:
S2mtrainings
Contact:
Event Manager;     Phone: [1-800-447-9407];     Email: s2mtraining18@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410799
25
Strategic Planning and Execution Amidst the Coronavirus: The 1-2-3 Year Plan for Enterprise Success
15 Mar 2021 • Fremont – online, United States
Organizer:
S2mtrainings
Contact:
Event Manager;     Phone: [1-800-447-9407];     Email: s2mtraining18@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410787
26
Validation Essentials for Medical Device Manufacturers - IQ, OQ, PQ
16 Mar 2021 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
This course will cover validation essentials for medical device manufacturers. Attendees will learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol writing, and change management. We’ll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
validation of medical devices, medical device process validation, medical device validation protocol, quality system regulations, iso 13485, iq oq pq medical devices
Event listing ID:
1409894
27
HIPAA, Texting, and Healthcare - Communicating Securely with Patients and Professionals
18 Mar 2021 • Fremont – online, United States
Organizer:
Webinarhealth
Contact:
Event Manager;     Phone: [1-800-385-1607];     Email: webinarhealth@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410607
Related subject(s):
28
Implementing a Risk-Based Plan with Next Steps for Industry After COVID-19
18 Mar 2021 • Fremont – online, United States
Organizer:
Planurevents
Contact:
Event Manager;     Phone: [1-800-447-9407];     Email: planurevents2020@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410667
29
History of Pandemics Impacting the Food Industry, Implementing a Risk-Based Plan with Next Steps for Industry After COVID-19
18 Mar 2021 • Fremont – online, United States
Organizer:
Vctrainings
Contact:
Event Manager;     Phone: [1-800-447-9407];     Email: vctrainings2020@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410632
30
Accommodating ADA Service Dogs in the Workplace
18 Mar 2021 • Fremont – online, United States
Organizer:
S2mtrainings
Contact:
Event Manager;     Phone: [1-800-447-9407];     Email: s2mtraining18@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410720
31
Joining in Car Body Engineering
24 Mar 2021 - 25 Mar 2021 • online, United States
Organizer:
North America-based Automotive Circle
Abstract:
While there is a great increase in the complexity of current car body projects, at the same time, when choosing the most suitable joining technology for each given situation, there are also a number of basic constraints. First and foremost, these include putting production efficiency and cost efficiency at the center of attention – without compromising the potential for flexibility. These are the topics that govern today’s discussions about automotive body shop technologies, and these are among the topics that are addressed at the our North America-based, annual “Joining in Car Body Engineering” conference, where our leading network of expert engineers gets together each year for an exchange of current progress reports from leading OEMs, innovations of important system suppliers and practical ideas of renowned research institutes.
Event listing ID:
1394554
32
The EU Medical Device Regulation (MDR 745/2017) - The New Process to Enter the European Market
25 Mar 2021 • Fremont – online, United States
Organizer:
Panelcompliance
Contact:
Event Manager;     Phone: [1-800-447-9407];     Email: panelcompliance@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410613
33
2-Day Virtual Seminar on Best Practices for Import & Export Control & Customs Compliance During & After COVID 19
25 Mar 2021 - 26 Mar 2021 • Fremont – online, United States
Organizer:
Vctrainings
Contact:
Event Manager;     Phone: [1-800-447-9407];     Email: vctrainings2020@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410719
34
HR Compliance 101 - For New HR/Non HR Managers, including COVID-19
26 Mar 2021 • Fremont – online, United States
Organizer:
Hrtrainonline
Contact:
Event Manager;     Phone: [1-800-385-1627];     Email: hrtrainonline@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410532
35
HIPAA, 42 CFR Part 2, and FERPA - Rules for Managing Student Health Information
30 Mar 2021 • Fremont – online, United States
Organizer:
Webinarhealth
Contact:
Event Manager;     Phone: [1-800-385-1607];     Email: webinarhealth@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410606
Related subject(s):
36
Marketing to Medicare or Medicaid Beneficiaries - What You Can and Cannot Do
31 Mar 2021 • Fremont – online, United States
Organizer:
Webinarhealth
Contact:
Event Manager;     Phone: [1-800-385-1607];     Email: webinarhealth@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410572
37
DigiMarCon New England 2021 - Digital Marketing, Media and Advertising Conference & Exhibition
06 May 2021 - 07 May 2021 • Boston, United States
Organizer:
DigiMarCon
Abstract:
DigiMarCon New England, the Premier Digital Marketing, Media and Advertising Conference & Exhibition in the New England region returns May 6th to 7th, 2021 to the luxurious Westin Copley Place Boston Hotel in downtown Boston, Massachusetts. Join your peers in-person or online for 2-days jam packed with digital marketing best practices, latest trends, practical solutions, strategy and networking, also check out the next generation of technology & innovation; Internet, Mobile, AdTech, MarTech & SaaS Technology.
Contact:
DigiMarCon New England;     Phone: [(800) 805 5385];     Email: events@digimarconnewengland.com
Event listing ID:
1377412
Related subject(s):
38
Tattoos, Sandals, Yarmulkes, Dress and Appearance: Increasing Legal Challenges for Employees and Employers
12 Jun 2021 • Palo Alto - webinar, United States
Organizer:
Complianceonline
Abstract:
This webinar training will explain the role of HR professionals and managers in implementing discrimination-free dress code to ensure all job candidates and employees are treated fairly and equitably. Dress codes are receiving a fair amount of attention in the courts these days with number of precedent setting lawsuits dealing with dress codes’ requirements. The instructor will explain how your current dress code can discriminate against potential and current employees based on their gender, religion, and race, to name a few and lead to lawsuits.
Contact:
Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Tattoos, dress code, discrimination-free dress code, HR lawsuits, workplace issue, EEOC Laws
Event listing ID:
1355972
Related subject(s):
39
Moving from an Operational Manager to a Strategic Leader
03 Aug 2021 • Fremont (webinar), United States
Organizer:
Traininng.com
Contact:
Traininng.com;     Email: traininngdotcom@gmail.com
Event listing ID:
1363174
40
PowerPoint on the Fast Track: Presentations in Minutes not Hours
04 Aug 2021 • Fremont (webinar), United States
Organizer:
Traininng.com
Abstract:
We'll begin by showing you how and why you should begin every presentation with an outline. The outline then becomes the framework of the presentation itself. Then we cover how to create and apply Microsoft Themes to get the precise look and feel that represents your organization's identity. You'll see how to take your current company presentation template and turn it into a theme that can be repurposed all throughout Microsoft Office. You will finally understand how to leverage the Slide Master to create multiple slide layouts that are consistent from presentation to presentation.
Contact:
Traininng.com;     Email: traininngdotcom@gmail.com
Event listing ID:
1363122
41
Solving Statistical Mysteries - What Does FDA Want?
04 Aug 2021 • Fremont (webinar), United States
Organizer:
Traininng.com
Contact:
Traininng.com;     Email: traininngdotcom@gmail.com
Event listing ID:
1363142
42
Positive Approaches for Improving Performance
04 Aug 2021 • Fremont (webinar), United States
Organizer:
Traininng.com
Abstract:
Unlike punitive disciplinary systems, the positive approach emphasizes reminders of expected performance and sincere praise, not warnings or reprimands. It is important to determine what motivates your team to drive that motivation. Positive approaches to discipline allow authority to identify potential issues and resolve conflict in a constructive way. Communicating standards and creating policies that ensure equality will improve performance in any space.
Contact:
Traininng.com;     Email: traininngdotcom@gmail.com
Event listing ID:
1363228
43
Using Learning Management Systems (LMS) to Develop Pharma Training: Rewards & Challenges
21 Sep 2022 • online, United States
Organizer:
compliance4all
Abstract:
Overview:

Learning Management Systems (LMSs) are important tools for assuring and demonstrating that Pharma employees maintain their training, and their GMP compliance, up to date.

They often boast great functionality but also have limitations that must be overcome for a Pharma company to use them effectively. An area that is not understood well is the development of training curricula in these systems, which presents its own unique challenges and takes far more time to implement than is commonly thought.

In addition, many employees have these responsibilities in addition to others not necessarily related to training and do not have the luxury of time to create and maintain a complex array of curricula.

Contact:
Compliance4all;     Phone: [8004479407];     Email: support@compliance4All.com
Event listing ID:
1368599
44
Hazardous Material Release Reporting Requirements
22 Sep 2022 • online, United States
Organizer:
compliance4all
Abstract:
Overview:

Hazardous materials pose a danger to the environment. Federal regulations require immediate reporting to specific agencies (federal and local) in the event of a release to the environment.

We will cover the diferrent requirements, how to determine if you are required to report a release, and strategies to implement proactive actions to minimize the likelihood of a release, and you internal response time to avoid or minimize any potential enforcement actions.

Why you should Attend: The inspection requirements of the SPCC rule are designed to detect oil leaks, spills, or other potential integrity or structural issues before they can result in a discharge of oil to navigable waters of the U.S. or adjoining shorelines.

Regularly scheduled inspections, evaluations, and testing of bulk oil storage containers by qualified personnel are critical parts of discharge prevention. A container integrity inspection and/or testing program may involve one or more of the following: an external visual inspection of containers, foundations, and supports; non-destructive testing (examination) to evaluate integrity of certain containers; and additional evaluations, as needed, to assess the containers’ fitness for continued service.

The type of inspection program and its scope will depend on site specific condition and the application of good engineering practices and this can be accomplished by following applicable industry standards.

Areas Covered in the Session:

Reportable Quantities

CERLA Releases and Reporting

Harmful Discharges under the CWA

EPCRA Release Reporting

Chemical Safety Board (CSB) New rule

Who Will Benefit:

Environmental Managers

Environmental Supervisors

Environmental Technicians

EHS Managers

EHS Supervisors

EHS Technicians

Speaker Profile

Robert A. (Bob) LaRosa, PE, is an environmental engineer and regulatory compliance specialist with more than 30 years’ experience supporting clients in the federal government and in a variety of industries, including chemical, petroleum, transportation, telecommunication, food processing, pharmaceuticals. He has developed and implements SPCC plans at more than 100 different facilities in the transportation, industrial, commercial and government sectors.

As a licensed Professional Engineer, Bob reviews and approves release reporting plans for his clients. Bob is an effective and practiced instructor, with experience delivering more than 60 courses to nearly 1,000 students.

Contact:
Compliance4all;     Phone: [8004479407];     Email: support@compliance4All.com
Event listing ID:
1368567
45
Equipment Validation, Tracking, Calibration and Preventive Maintenance
23 Sep 2022 • online, United States
Organizer:
compliance4all
Abstract:
Overview:

FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment.

The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements.

Contact:
Compliance4all;     Phone: [8004479407];     Email: support@compliance4All.com
Event listing ID:
1368502
Related subject(s):
46
21 CFR Part 11 - Compliance for Electronic Records and Signatures
29 Sep 2022 • online, United States
Organizer:
compliance4all
Abstract:
Overview:

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.

Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.

FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both.

The confusion over the original FDA regulation and its subsequent "selective enforcement" will be explained. FDA requirements for 21CFR Part 11 validation will be explained. the requirements are composed of technical and procedural aspects. open, closed and hybrid (paper and electronic) systems will be explained.

Contact:
Compliance4all;     Phone: [8004479407];     Email: support@compliance4All.com
Event listing ID:
1368492
47
Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities
30 Sep 2022 • online, United States
Organizer:
compliance4all
Abstract:
Overview:

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Over time, there have been several misunderstandings between supplier / contractors and pharmaceutical / biologic finished product manufacturers.The root of many of the problems lies in a lack of a suitable agreement delineating roles, responsibilities and resolution to agreement to these issues. Part of these arrangements typically involve the development, support and updating of confidential technical files (Drug Master files) which allow suppliers to protect their confidential product and process information from each and every customer and share it only with the Agency.

Contact:
Compliance4all;     Phone: [8004479407];     Email: support@compliance4All.com
Event listing ID:
1368587


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: 23 February 2021