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FDA Electronic Medical Device Reporting and eMDR Files

The United States Food and Drug Administration Electronic Medical Device Report (eMDR) Files Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) Files The FDA/CDRH staff has created a packet of files to assist in implementing software for generating the

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John March 10, 2016March 10, 2016 eMDR, FDA, Medical Device Reporting, medical devices Read more

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Upcoming Events

Apr
27
Fri
2:00 PM Developing and Implementing an E...
Developing and Implementing an E...
Apr 27 @ 2:00 PM – 3:00 PM
Developing and Implementing an Effective SOP in Healthcare Industry @ Global Compliance Seminar
LIVE Online Seminar Developing and Implementing an Effective SOP in Healthcare Industry Date: January 27, 2017 NOTE: This seminar recurrs tri-monthly (every three month) on 4th Fridays. Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after
May
2
Wed
3:00 PM FDA Pre-Submission and 510k Best...
FDA Pre-Submission and 510k Best...
May 2 @ 3:00 PM – 4:00 PM
FDA Pre-Submission and 510k Best Practices
LIVE Online Seminar FDA Pre-submission and 510(k); Best Practices Date: November 2, 2016 NOTE: This 510(k) LIVE seminar recurrs monthly on 1st Wednesdays. Time: 12:00 PM PST | 03:00 PM EST Duration: 60 Minutes. About the Seminar This presentation will walk you
May
7
Mon
all-day How to Format Succinct and Compr...
How to Format Succinct and Compr...
May 7 all-day
How to Format Succinct and Comprehensive 510ks and PMAs @ Online
[RECORDED] How to Format Succinct and Comprehensive 510ks and PMAs The following two products are recorded versions of two day LIVE online seminars. Day One: How to Format Succinct and Comprehensive 510ks Product Code “GCS-128R-510k Seminar” 510(k) Regulatory Requirements Review of
1:00 PM Fundamentals of Regulatory Affai...
Fundamentals of Regulatory Affai...
May 7 @ 1:00 PM – 2:00 PM
Fundamentals of Regulatory Affairs in Drugs @ Online
LIVE Online Seminar Programs in Regulatory Affairs Fundamentals of Regulatory Affairs in Drugs (“Drug Program“) Course Description Each class consists of 60-minutes of online seminar (LIVE or recorded) There are four classes for each program. The Drug Program begins on
1:00 PM The Fundamentals of Regulatory A...
The Fundamentals of Regulatory A...
May 7 @ 1:00 PM – 2:00 PM
The Fundamentals of Regulatory Affairs @ Online
Two LIVE Online Programs in Regulatory Affairs The Fundamentals of Regulatory Affairs for Drugs (“Drug Program“) and Medical Devices (“Device Program“) Course Description Each class consists of 60-minutes of online seminar (LIVE or recorded) There are four classes for each program.
May
10
Thu
3:00 PM FDA 510k Requirements, Submissio...
FDA 510k Requirements, Submissio...
May 10 @ 3:00 PM – 4:00 PM
FDA 510k Requirements, Submission, and Clearance @ LIVE Online Seminar (LIVE Webinar)
LIVE Online Seminar FDA 510(k): Requirements, Submission, and Clearance Date: September 10, 2015 NOTE: This 510(k) LIVE seminar recurrs bi-monthly on second Thursdays. Time: 12:00 PM PST | 03:00 PM EST Duration: 60 Minutes. About the Seminar This presentation will walk you
May
11
Fri
2:00 PM LIVE 510k Webinar
LIVE 510k Webinar
May 11 @ 2:00 PM – 3:00 PM
LIVE 510k Webinar @ LIVE Online Seminar (LIVE Webinar)
LIVE Online Seminar FDA 510(k): Preparation, Submission, and Clearance Date: November 11, 2016 NOTE: This 510(k) LIVE seminar recurrs monthly on 2nd Fridays. Your payment would apply for the next upcoming LIVE online seminar unless indicated otherwise after registration. Time: 11:00 AM
Jun
4
Mon
all-day How to Format Succinct and Compr...
How to Format Succinct and Compr...
Jun 4 all-day
How to Format Succinct and Comprehensive 510ks and PMAs @ Online
[RECORDED] How to Format Succinct and Comprehensive 510ks and PMAs The following two products are recorded versions of two day LIVE online seminars. Day One: How to Format Succinct and Comprehensive 510ks Product Code “GCS-128R-510k Seminar” 510(k) Regulatory Requirements Review of
1:00 PM Fundamentals of Regulatory Affai...
Fundamentals of Regulatory Affai...
Jun 4 @ 1:00 PM – 2:00 PM
Fundamentals of Regulatory Affairs in Medical Devices @ Global Compliance Seminar (Online)
LIVE Online Seminar Programs in Regulatory Affairs The Fundamentals of Regulatory Affairs in Medical Devices (“Device Program”) Course Description Each class consists of 60-minutes of online seminar (LIVE or recorded) There are four classes for each program. The Drug Program
1:00 PM The Fundamentals of Regulatory A...
The Fundamentals of Regulatory A...
Jun 4 @ 1:00 PM – 2:00 PM
The Fundamentals of Regulatory Affairs @ Online
Two LIVE Online Programs in Regulatory Affairs The Fundamentals of Regulatory Affairs for Drugs (“Drug Program“) and Medical Devices (“Device Program“) Course Description Each class consists of 60-minutes of online seminar (LIVE or recorded) There are four classes for each program.
Jun
5
Tue
4:00 PM Risk Management for Medical Devi...
Risk Management for Medical Devi...
Jun 5 @ 4:00 PM – 5:00 PM
Risk Management for Medical Devices and IVDs Systematic and Holistic Approaches @ LIVE Online Seminar (LIVE Webinar)
LIVE Online Seminar Risk Management for Medical Devices and IVDs: Systematic and Holistic Approaches Date: June 6, 2017 NOTE: This LIVE seminar recurrs bi-monthly (every other month) on 1st Tuesdays. Your payment would apply for the next upcoming LIVE online seminar unless indicated
Jun
6
Wed
3:00 PM FDA Pre-Submission and 510k Best...
FDA Pre-Submission and 510k Best...
Jun 6 @ 3:00 PM – 4:00 PM
FDA Pre-Submission and 510k Best Practices
LIVE Online Seminar FDA Pre-submission and 510(k); Best Practices Date: November 2, 2016 NOTE: This 510(k) LIVE seminar recurrs monthly on 1st Wednesdays. Time: 12:00 PM PST | 03:00 PM EST Duration: 60 Minutes. About the Seminar This presentation will walk you
Jun
8
Fri
11:00 AM Medical Device Laws and Regulati...
Medical Device Laws and Regulati...
Jun 8 @ 11:00 AM – 12:00 PM
Medical Device Laws and Regulations in Asian Countries @ LIVE Online Seminar (LIVE Webinar)
LIVE Online Seminar Medical Device Laws and Regulations in Asian Countries: China, Hong Kong, Japan and Korea Date:  June 9, 2017 NOTE: This seminar recurrs tri-monthly (every three month) on 2nd Fridays. Your payment will apply for the next upcoming LIVE online seminar
12:00 PM How to Most Effectively Prepare ...
How to Most Effectively Prepare ...
Jun 8 @ 12:00 PM – 1:30 PM
How to Most Effectively Prepare for the US RAC Exam @ Online
LIVE Online Seminar How to Most Effectively Prepare for the US RAC Exam Date: April 13, 2018 Time: 09:00 AM PST | 12:00 PM EST Duration: 90 Minutes About the Seminar Having a credential for Regulatory Affairs Certification (RAC) can
1:00 PM Good Social Media Practices to A...
Good Social Media Practices to A...
Jun 8 @ 1:00 PM – 2:00 PM
Good Social Media Practices to Avoid FDA Actions @ LIVE Online Seminar (LIVE Webinar)
LIVE Online Seminar Establishing FDA-Compliant Social Media Practices to Avoid FDA Actions Date: December 9, 2016 NOTE: This seminar recurrs bi-monthly on second Fridays. Time: 09:00 AM PST | 12:00 PM EST Duration: 60 Minutes. About the Seminar This seminar is intended to
2:00 PM LIVE 510k Webinar
LIVE 510k Webinar
Jun 8 @ 2:00 PM – 3:00 PM
LIVE 510k Webinar @ LIVE Online Seminar (LIVE Webinar)
LIVE Online Seminar FDA 510(k): Preparation, Submission, and Clearance Date: November 11, 2016 NOTE: This 510(k) LIVE seminar recurrs monthly on 2nd Fridays. Your payment would apply for the next upcoming LIVE online seminar unless indicated otherwise after registration. Time: 11:00 AM
4:00 PM Developing and Implementing a Gl...
Developing and Implementing a Gl...
Jun 8 @ 4:00 PM – 5:00 PM
Developing and Implementing a Global Regulatory Plan and Strategy @ LIVE Online Seminar (LIVE Webinar)
LIVE Online Seminar Developing and Implementing a Global Regulatory Plan and Strategy Date: April 13, 2018 NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Fridays. Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
Jun
11
Mon
11:00 AM Overview of the EMA Marketing Au...
Overview of the EMA Marketing Au...
Jun 11 @ 11:00 AM – 12:00 PM
Overview of the EMA Marketing Authorization Applications for Medicinal Products @ Online
LIVE Seminar Online Overview of the EMA Marketing Authorization Applications (MAAs) for Medicinal Products for Human Use in EU Date: December 11, 2017 or email us to schedule a date and time NOTE: This seminar recurrs tri-monthly (every three month) on
1:00 PM Quality Risk Management for Drug...
Quality Risk Management for Drug...
Jun 11 @ 1:00 PM – 2:00 PM
Quality Risk Management for Drugs Biologics and Biosimilars-Systematic and Holistic Approaches @ LIVE Online Seminar (LIVE Webinar)
LIVE Online Seminar Quality Risk Management for Drugs and Biologics: Systematic and Holistic Approaches Date: June 12, 2017 NOTE: This seminar recurrs tri-monthly (every three month) on 2nd Mondays. Time: 12:00 PM PST | 03:00 PM EST Duration: 60 Minutes About the
2:00 PM FDA Inspection Preparation and R...
FDA Inspection Preparation and R...
Jun 11 @ 2:00 PM – 3:00 PM
FDA Inspection Preparation and Readiness
LIVE Online Seminar FDA Inspection Preparation and Readiness: the Top 20 Most Common GMP Deficiencies for Device Manufacturers Date: June 12, 2017 NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Mondays. Your payment will apply for the next upcoming LIVE online
2:00 PM PMA Drafting Seminars
PMA Drafting Seminars
Jun 11 @ 2:00 PM – 3:00 PM
PMA Drafting Seminars @ LIVE Online
LIVE Online Seminar PMA Drafting Seminars Date: Starting on April 9, 2018 NOTE: This seminar recurrs bi-monthly (every other month) February, April, June, August, October and December Time: 2nd Mondays at 11:00 AM EST OR 2:00 PM EST OR by scheduling at your
Jun
12
Tue
3:00 PM 510k Drafting Seminars
510k Drafting Seminars
Jun 12 @ 3:00 PM – 4:00 PM
510k Drafting Seminars @ LIVE Online
LIVE Online Seminar Learning LIVE How To Draft a 510(k) Like a PRO Date: recommended to contact us to schedule the 510(k) seminar (online) NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Mondays. Your payment will apply for the next
1:00 PM Establishing an FDA-Compliant UD...
Establishing an FDA-Compliant UD...
Jun 12 @ 1:00 PM – 2:00 PM
Establishing an FDA-Compliant UDI System @ Your Computer (Online)
LIVE Online Seminar Establishing an FDA-Compliant UDI System Date: June 13, 2017 NOTE: This seminar recurrs tri-monthly (every three month) on 2nd Tuesdays. Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration. Time: 10:00 AM
3:00 PM CE Mark Content and Format for a...
CE Mark Content and Format for a...
Jun 12 @ 3:00 PM – 4:00 PM
CE Mark Content and Format for a Technical File and Design Dossier @ LIVE Online Seminar (LIVE Webinar)
LIVE Online Seminar CE Mark: Content and Format for a Technical File and Design Dossier Date: June 13, 2017 NOTE: This seminar recurrs tri-monthly (every 3 month) on 2nd Tuesdays. Your payment will apply for the next upcoming LIVE online seminar unless requested
Jun
13
Wed
4:00 PM Demystifying Design Control Incl...
Demystifying Design Control Incl...
Jun 13 @ 4:00 PM – 5:00 PM
Demystifying Design Control Including DHF DHR and DMR @ LIVE Online Seminar
LIVE Seminar Online Demystifying Design Control: Design History File (DHF), Device History Record (DHR), and Device Master Record (DMR) Date: June 14, 2017 NOTE: This seminar recurrs tri-monthly (every three month) on 2nd Wednesdays. Your payment will apply for the
Jun
14
Thu
11:00 AM LIVE Seminar Best Practices for ...
LIVE Seminar Best Practices for ...
Jun 14 @ 11:00 AM – 12:00 PM
LIVE Seminar Best Practices for Communicating and Interacting with FDA Reviewers @ LIVE Online Seminar (LIVE Webinar)
LIVE Online Seminar Best Practices for Communicating and Interacting with FDA Reviewers Date: December 8, 2016 This seminar recurs tri-monthly on second Thursdays. Time: 08:00 AM PST | 11:00 AM EST Duration: 60 Minutes About the Seminar This seminar (webinar) is intended to
12:00 PM Establishing an FDA-Compliant UD...
Establishing an FDA-Compliant UD...
Jun 14 @ 12:00 PM – 1:00 PM
Establishing an FDA-Compliant UDI System @ LIVE Online Seminar (LIVE Webinar)
LIVE Online Seminar Establishing an FDA-Compliant UDI System Date: October 8, 2015 NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Thursdays. Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration. Time: 12:00 PM
3:00 PM Implementing Medical Device Comp...
Implementing Medical Device Comp...
Jun 14 @ 3:00 PM – 4:00 PM
Implementing Medical Device Complaint Handling Systems @ Your Computer (Online)
LIVE Online Seminar Implementing Medical Device Complaint Handling Systems Date: April 13, 2017 NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Thursdays. Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration. Time: 12:00
4:00 PM Complaint Handing and Medical De...
Complaint Handing and Medical De...
Jun 14 @ 4:00 PM – 5:00 PM
Complaint Handing and Medical Device Reporting @ LIVE Online
LIVE Online Seminar Title: Complaint Handling and Medical Device Reporting (MDR) Date: December 8, 2016 This seminar recurs tri-monthly on second Thursdays. Time: 01:00 PM PST | 04:00 PM EST Duration: 60 Minutes About the Seminar As a domestic or foreign medical device manufacturer
Jun
15
Fri
1:00 PM Understanding ANDAs and Paragrap...
Understanding ANDAs and Paragrap...
Jun 15 @ 1:00 PM – 2:00 PM
Understanding ANDAs and Paragraph IV Patent Certifications @ Online
LIVE Online Seminar Understanding ANDAs and Paragraph IV Patent Certifications Date: December 9 , 2016 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes About the Seminar The regulatory requirements for generic drugs include, but not limited to,
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RSS FDA Guidance Information

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    FDA Guidance for the Industry Completeness Assessments for Type II API DMFs Under GDUFA By Global Compliance Seminar (LinkedIn; Twitter) This guidance is intended for holders of Type (more…)
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    FDA Guidance for the Industry By Global Compliance Seminar (LinkedIn; Twitter) Data Integrity and Compliance With CGMP The purpose of this guidance is to clarify the role of (more…)
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Upcoming Events

Apr
27
Fri
2:00 PM Developing and Implementing an E...
Developing and Implementing an E...
Apr 27 @ 2:00 PM – 3:00 PM
Developing and Implementing an Effective SOP in Healthcare Industry @ Global Compliance Seminar
LIVE Online Seminar Developing and Implementing an Effective SOP in Healthcare Industry Date: January 27, 2017 NOTE: This seminar recurrs tri-monthly (every three month) on 4th Fridays. Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after
May
2
Wed
3:00 PM FDA Pre-Submission and 510k Best...
FDA Pre-Submission and 510k Best...
May 2 @ 3:00 PM – 4:00 PM
FDA Pre-Submission and 510k Best Practices
LIVE Online Seminar FDA Pre-submission and 510(k); Best Practices Date: November 2, 2016 NOTE: This 510(k) LIVE seminar recurrs monthly on 1st Wednesdays. Time: 12:00 PM PST | 03:00 PM EST Duration: 60 Minutes. About the Seminar This presentation will walk you
May
7
Mon
all-day How to Format Succinct and Compr...
How to Format Succinct and Compr...
May 7 all-day
How to Format Succinct and Comprehensive 510ks and PMAs @ Online
[RECORDED] How to Format Succinct and Comprehensive 510ks and PMAs The following two products are recorded versions of two day LIVE online seminars. Day One: How to Format Succinct and Comprehensive 510ks Product Code “GCS-128R-510k Seminar” 510(k) Regulatory Requirements Review of
1:00 PM Fundamentals of Regulatory Affai...
Fundamentals of Regulatory Affai...
May 7 @ 1:00 PM – 2:00 PM
Fundamentals of Regulatory Affairs in Drugs @ Online
LIVE Online Seminar Programs in Regulatory Affairs Fundamentals of Regulatory Affairs in Drugs (“Drug Program“) Course Description Each class consists of 60-minutes of online seminar (LIVE or recorded) There are four classes for each program. The Drug Program begins on
1:00 PM The Fundamentals of Regulatory A...
The Fundamentals of Regulatory A...
May 7 @ 1:00 PM – 2:00 PM
The Fundamentals of Regulatory Affairs @ Online
Two LIVE Online Programs in Regulatory Affairs The Fundamentals of Regulatory Affairs for Drugs (“Drug Program“) and Medical Devices (“Device Program“) Course Description Each class consists of 60-minutes of online seminar (LIVE or recorded) There are four classes for each program.
May
10
Thu
3:00 PM FDA 510k Requirements, Submissio...
FDA 510k Requirements, Submissio...
May 10 @ 3:00 PM – 4:00 PM
FDA 510k Requirements, Submission, and Clearance @ LIVE Online Seminar (LIVE Webinar)
LIVE Online Seminar FDA 510(k): Requirements, Submission, and Clearance Date: September 10, 2015 NOTE: This 510(k) LIVE seminar recurrs bi-monthly on second Thursdays. Time: 12:00 PM PST | 03:00 PM EST Duration: 60 Minutes. About the Seminar This presentation will walk you
May
11
Fri
2:00 PM LIVE 510k Webinar
LIVE 510k Webinar
May 11 @ 2:00 PM – 3:00 PM
LIVE 510k Webinar @ LIVE Online Seminar (LIVE Webinar)
LIVE Online Seminar FDA 510(k): Preparation, Submission, and Clearance Date: November 11, 2016 NOTE: This 510(k) LIVE seminar recurrs monthly on 2nd Fridays. Your payment would apply for the next upcoming LIVE online seminar unless indicated otherwise after registration. Time: 11:00 AM
Jun
4
Mon
all-day How to Format Succinct and Compr...
How to Format Succinct and Compr...
Jun 4 all-day
How to Format Succinct and Comprehensive 510ks and PMAs @ Online
[RECORDED] How to Format Succinct and Comprehensive 510ks and PMAs The following two products are recorded versions of two day LIVE online seminars. Day One: How to Format Succinct and Comprehensive 510ks Product Code “GCS-128R-510k Seminar” 510(k) Regulatory Requirements Review of
1:00 PM Fundamentals of Regulatory Affai...
Fundamentals of Regulatory Affai...
Jun 4 @ 1:00 PM – 2:00 PM
Fundamentals of Regulatory Affairs in Medical Devices @ Global Compliance Seminar (Online)
LIVE Online Seminar Programs in Regulatory Affairs The Fundamentals of Regulatory Affairs in Medical Devices (“Device Program”) Course Description Each class consists of 60-minutes of online seminar (LIVE or recorded) There are four classes for each program. The Drug Program
1:00 PM The Fundamentals of Regulatory A...
The Fundamentals of Regulatory A...
Jun 4 @ 1:00 PM – 2:00 PM
The Fundamentals of Regulatory Affairs @ Online
Two LIVE Online Programs in Regulatory Affairs The Fundamentals of Regulatory Affairs for Drugs (“Drug Program“) and Medical Devices (“Device Program“) Course Description Each class consists of 60-minutes of online seminar (LIVE or recorded) There are four classes for each program.
Jun
5
Tue
4:00 PM Risk Management for Medical Devi...
Risk Management for Medical Devi...
Jun 5 @ 4:00 PM – 5:00 PM
Risk Management for Medical Devices and IVDs Systematic and Holistic Approaches @ LIVE Online Seminar (LIVE Webinar)
LIVE Online Seminar Risk Management for Medical Devices and IVDs: Systematic and Holistic Approaches Date: June 6, 2017 NOTE: This LIVE seminar recurrs bi-monthly (every other month) on 1st Tuesdays. Your payment would apply for the next upcoming LIVE online seminar unless indicated
Jun
6
Wed
3:00 PM FDA Pre-Submission and 510k Best...
FDA Pre-Submission and 510k Best...
Jun 6 @ 3:00 PM – 4:00 PM
FDA Pre-Submission and 510k Best Practices
LIVE Online Seminar FDA Pre-submission and 510(k); Best Practices Date: November 2, 2016 NOTE: This 510(k) LIVE seminar recurrs monthly on 1st Wednesdays. Time: 12:00 PM PST | 03:00 PM EST Duration: 60 Minutes. About the Seminar This presentation will walk you
Jun
8
Fri
11:00 AM Medical Device Laws and Regulati...
Medical Device Laws and Regulati...
Jun 8 @ 11:00 AM – 12:00 PM
Medical Device Laws and Regulations in Asian Countries @ LIVE Online Seminar (LIVE Webinar)
LIVE Online Seminar Medical Device Laws and Regulations in Asian Countries: China, Hong Kong, Japan and Korea Date:  June 9, 2017 NOTE: This seminar recurrs tri-monthly (every three month) on 2nd Fridays. Your payment will apply for the next upcoming LIVE online seminar
12:00 PM How to Most Effectively Prepare ...
How to Most Effectively Prepare ...
Jun 8 @ 12:00 PM – 1:30 PM
How to Most Effectively Prepare for the US RAC Exam @ Online
LIVE Online Seminar How to Most Effectively Prepare for the US RAC Exam Date: April 13, 2018 Time: 09:00 AM PST | 12:00 PM EST Duration: 90 Minutes About the Seminar Having a credential for Regulatory Affairs Certification (RAC) can
1:00 PM Good Social Media Practices to A...
Good Social Media Practices to A...
Jun 8 @ 1:00 PM – 2:00 PM
Good Social Media Practices to Avoid FDA Actions @ LIVE Online Seminar (LIVE Webinar)
LIVE Online Seminar Establishing FDA-Compliant Social Media Practices to Avoid FDA Actions Date: December 9, 2016 NOTE: This seminar recurrs bi-monthly on second Fridays. Time: 09:00 AM PST | 12:00 PM EST Duration: 60 Minutes. About the Seminar This seminar is intended to
2:00 PM LIVE 510k Webinar
LIVE 510k Webinar
Jun 8 @ 2:00 PM – 3:00 PM
LIVE 510k Webinar @ LIVE Online Seminar (LIVE Webinar)
LIVE Online Seminar FDA 510(k): Preparation, Submission, and Clearance Date: November 11, 2016 NOTE: This 510(k) LIVE seminar recurrs monthly on 2nd Fridays. Your payment would apply for the next upcoming LIVE online seminar unless indicated otherwise after registration. Time: 11:00 AM
4:00 PM Developing and Implementing a Gl...
Developing and Implementing a Gl...
Jun 8 @ 4:00 PM – 5:00 PM
Developing and Implementing a Global Regulatory Plan and Strategy @ LIVE Online Seminar (LIVE Webinar)
LIVE Online Seminar Developing and Implementing a Global Regulatory Plan and Strategy Date: April 13, 2018 NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Fridays. Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
Jun
11
Mon
11:00 AM Overview of the EMA Marketing Au...
Overview of the EMA Marketing Au...
Jun 11 @ 11:00 AM – 12:00 PM
Overview of the EMA Marketing Authorization Applications for Medicinal Products @ Online
LIVE Seminar Online Overview of the EMA Marketing Authorization Applications (MAAs) for Medicinal Products for Human Use in EU Date: December 11, 2017 or email us to schedule a date and time NOTE: This seminar recurrs tri-monthly (every three month) on
1:00 PM Quality Risk Management for Drug...
Quality Risk Management for Drug...
Jun 11 @ 1:00 PM – 2:00 PM
Quality Risk Management for Drugs Biologics and Biosimilars-Systematic and Holistic Approaches @ LIVE Online Seminar (LIVE Webinar)
LIVE Online Seminar Quality Risk Management for Drugs and Biologics: Systematic and Holistic Approaches Date: June 12, 2017 NOTE: This seminar recurrs tri-monthly (every three month) on 2nd Mondays. Time: 12:00 PM PST | 03:00 PM EST Duration: 60 Minutes About the
2:00 PM FDA Inspection Preparation and R...
FDA Inspection Preparation and R...
Jun 11 @ 2:00 PM – 3:00 PM
FDA Inspection Preparation and Readiness
LIVE Online Seminar FDA Inspection Preparation and Readiness: the Top 20 Most Common GMP Deficiencies for Device Manufacturers Date: June 12, 2017 NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Mondays. Your payment will apply for the next upcoming LIVE online
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RSS FDA Regulatory Doctor

  • Learn about Egg Safety
    The United States Food and Drug Administration (FDA) Egg Safety – Protect Yourself and Your Family! Fresh eggs, even those with clean, uncracked shells, may contain bacteria called Salmonella that can cause foodborne illness, often called “food poisoning.” Egg Cookbook
  • Johnson and Johnson Baby Powder May Be Linked to Cancer
    Talcum Powder May Be Linked to Ovarian Cancer? A Saint Louis jury awarded the family of a Tarrant woman $72 million for her claims that the Johnson & Johnson’s talc-based power caused her ovarian cancer.  The Johnson & Johnson is
  • Johnson and Johnson Baby Power May Be Linked to Cancer
    Talcum Powder May Be Linked to Ovarian Cancer? A Saint Louis jury awarded the family of a Tarrant woman $72 million for her claims that the Johnson & Johnson’s talc-based power caused her ovarian cancer.  The Johnson & Johnson is
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    Contraceptive Medical Device: Essure Problems Permanent Birth Control FDA approval for Essure – read from REGULATORY DOCTOR FDA Action for Essure Safety and Potential Risks Hysterectomy Surgery is performed to remove a woman’s womb (uterus) and sometimes, the cervix. The
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    The US Food and Drug Administration (FDA)  FDA takes additional action to better understand safety of Essure, inform patients of potential risks February 29, 2016 FDA Release The U.S. Food and Drug Administration announced today actions to provide important information

Recent Posts

  • Use of ISO 10993-1 Within a Risk Management Process
  • FDA Final Rule for Use of Symbols in Labeling
  • Registration, Evaluation, Authorisation and Restriction of Chemicals in EU
  • Transition Date for EN ISO 13485 Amended to Be 31 March 2019
  • FDA Electronic Medical Device Reporting and eMDR Files
  • TGA Regulatory Guidelines for Medical Devices
  • Specification Developer and Manufacturer Hit with FDA Warning Letters
  • FDA Warns a Device Firm of Validation Studies of the Laser Etching Process
  • ASQ Presents the Key Themes in the ISO 9001 Revision
  • FDA Revises Reyataz (atazanavir) Oral Powder Label

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RSS FDA Guidance Information

  • FDA Guidance on Expansion of the Abbreviated 510k Program
    FDA Issued the Draft Guidance on the Expansion of the Abbreviated 510(k) Program Today, the United States Food and Drug Administration (FDA) has issued the (more…)
  • Completeness Assessments for Type II API DMFs Under GDUFA
    FDA Guidance for the Industry Completeness Assessments for Type II API DMFs Under GDUFA By Global Compliance Seminar (LinkedIn; Twitter) This guidance is intended for holders of Type (more…)
  • Use of ISO 10993-1 for Medical Device Risk Management Process
    FDA Guidance for Industry By Global Compliance Seminar (LinkedIn; Twitter) Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within (more…)
  • FDA Data Integrity and Compliance with CGMP
    FDA Guidance for the Industry By Global Compliance Seminar (LinkedIn; Twitter) Data Integrity and Compliance With CGMP The purpose of this guidance is to clarify the role of (more…)
  • ANDA Submissions-Content and Format
    Guidance for Industry By Global Compliance Seminar (LinkedIn; Twitter) ANDA Submissions-Content and Format of Abbreviated New Drug Applications June 2014 Generics This guidance is intended to assist applicants (more…)

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