Share
Sun Mon Tue Wed Thu Fri Sat
1
2
3
Fundamentals of Regulatory Affairs in Medical Devices 1:00 PM
Fundamentals of Regulatory Affairs in Medical Devices
Dec 3 @ 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
The Fundamentals of Regulatory Affairs 1:00 PM
The Fundamentals of Regulatory Affairs
Dec 3 @ 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.
4
Risk Management for Medical Devices and IVDs Systematic and Holistic Approaches 4:00 PM
Risk Management for Medical Devices and IVDs Systematic and Holistic Approaches
Dec 4 @ 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
5
FDA Pre-Submission and 510k Best Practices 3:00 PM
FDA Pre-Submission and 510k Best Practices
Dec 5 @ 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
6
7
8
9
10
Overview of the EMA Marketing Authorization Applications for Medicinal Products 11:00 AM
Overview of the EMA Marketing Authorization Applications for Medicinal Products
Dec 10 @ 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
Quality Risk Management for Drugs Biologics and Biosimilars-Systematic and Holistic Approaches 1:00 PM
Quality Risk Management for Drugs Biologics and Biosimilars-Systematic and Holistic Approaches
Dec 10 @ 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
FDA Inspection Preparation and Readiness 2:00 PM
FDA Inspection Preparation and Readiness
Dec 10 @ 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
PMA Drafting Seminars 2:00 PM
PMA Drafting Seminars
Dec 10 @ 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
11
510k Drafting Seminars 4:00 PM
510k Drafting Seminars
Dec 11 @ 4:00 PM – 5:00 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
Establishing an FDA-Compliant UDI System 1:00 PM
Establishing an FDA-Compliant UDI System
Dec 11 @ 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
CE Mark Content and Format for a Technical File and Design Dossier 3:00 PM
CE Mark Content and Format for a Technical File and Design Dossier
Dec 11 @ 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
12
Demystifying Design Control Including DHF DHR and DMR 4:00 PM
Demystifying Design Control Including DHF DHR and DMR
Dec 12 @ 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
13
LIVE Seminar Best Practices for Communicating and Interacting with FDA Reviewers 11:00 AM
LIVE Seminar Best Practices for Communicating and Interacting with FDA Reviewers
Dec 13 @ 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
Implementing Medical Device Complaint Handling Systems 3:00 PM
Implementing Medical Device Complaint Handling Systems
Dec 13 @ 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
Complaint Handing and Medical Device Reporting 4:00 PM
Complaint Handing and Medical Device Reporting
Dec 13 @ 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
14
Medical Device Laws and Regulations in Asian Countries 11:00 AM
Medical Device Laws and Regulations in Asian Countries
Dec 14 @ 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
How to Most Effectively Prepare for the US RAC Exam 12:00 PM
How to Most Effectively Prepare for the US RAC Exam
Dec 14 @ 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
Good Social Media Practices to Avoid FDA Actions 1:00 PM
Good Social Media Practices to Avoid FDA Actions
Dec 14 @ 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
LIVE 510k Webinar 2:00 PM
LIVE 510k Webinar
Dec 14 @ 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
Developing and Implementing a Global Regulatory Plan and Strategy 4:00 PM
Developing and Implementing a Global Regulatory Plan and Strategy
Dec 14 @ 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.
15
16
17
Big Data in FDA-Regulated Healthcare Industry 11:00 AM
Big Data in FDA-Regulated Healthcare Industry
Dec 17 @ 11:00 AM – 12:00 PM
Big Data in FDA-Regulated Healthcare Industry @ Your Computer (Online)
LIVE Online Seminar  Big Data in FDA-Regulated Healthcare Industry: Best Practices for Systematic Use Date: December 19, 2016 NOTE: This seminar recurrs tri-monthly (every three month) on 3rd Mondays. Your payment will apply for the next upcoming LIVE online seminar unless requested
18
Implementing Compliance Requirements for Social Media Marketing Ads and Videos 3:00 PM
Implementing Compliance Requirements for Social Media Marketing Ads and Videos
Dec 18 @ 3:00 PM – 4:00 PM
Implementing Compliance Requirements for Social Media Marketing Ads and Videos @ Your Office (Online)
LIVE Online Seminar Implementing Compliance Requirements for Social Media Marketing Ads and Promotional Videos Date: February 16, 2016 NOTE: This seminar recurrs bi-monthly on third Tuesdays. Time: 12:00 PM PST | 03:00 PM EST Duration: 60 Minutes. About the Seminar This seminar is
19
20
FDA 510k Best Practices 3:00 PM
FDA 510k Best Practices
Dec 20 @ 3:00 PM – 4:00 PM
FDA 510k Best Practices @ Your Computer (Online)
LIVE Seminar Online FDA 510(k) Requirements, Submission, and Clearance: Best Practices Date: June 15, 2017 NOTE: This 510(k) LIVE seminar recurrs tri-monthly (every three month) on 3rd Thursdays. Your payment would apply for the next upcoming LIVE online seminar unless indicated otherwise
Implementing an Internal Audit Program Compliant with ISO 13485 and 21 CFR Part 820 3:00 PM
Implementing an Internal Audit Program Compliant with ISO 13485 and 21 CFR Part 820
Dec 20 @ 3:00 PM – 4:00 PM
Implementing an Internal Audit Program Compliant with ISO 13485 and 21 CFR Part 820 @ Online or Your Office
LIVE Online Seminar Implementing an Internal Audit Program Compliant with ISO 13485 and 21 CFR Part 820 Date: June 15, 2017 NOTE: This seminar recurrs tri-monthly (every three month) on 3rd Thursdays. Your payment will apply for the next upcoming LIVE online
21
Understanding ANDAs and Paragraph IV Patent Certifications 1:00 PM
Understanding ANDAs and Paragraph IV Patent Certifications
Dec 21 @ 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,
22
23
24
25
26
27
28
29
30
31