Cart 0
- Home
- About Us
- Webinars
-
Category
- Medical Device (ISO 13485)
- Drugs / Biologics
- FDA Compliance
- Food & Beverages
- Quality Management (ISO 9001)
- OSHA Compliance
- IT Security
- Sox Compliance
- Clinical Compliance
- Auditing/Accounting & Tax
- Banking & Insurance
- Geology and Mining
- Risk Management
- Project Management
- Intellectual Property Law
- Excel Spreadsheet Techniques
- FAA Compliance
- Trade & Logistics
- Retail
- Environmental Compliance
- Products/E-Books
Webinar Search Results : 7 Upcoming webinars found.
Tuesday,
April 23, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: John E Lincoln
The Most Serious FDA 483s - How to Avoid them
This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.
Wednesday,
May 8, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: John E Lincoln
Verification vs Validation-Product, Process or Equipment and QMS Software
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.
Tuesday,
May 21, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: John E Lincoln
Device Changes, FDA Changes, and the 510(k)
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
Wednesday,
May 29, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: John E Lincoln
3-Hour Virtual Seminar on DHF, DMR, DHR, TF , Design Dossiers - The Requirements
This webinar will examine the existing and proposed requiements for the U.S. FDA's DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivitive documents, the DMR and DHR. It will consider the European Union's MDD TF/DD and its transition to the EU MDR requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Tuesday,
June 18, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: John E Lincoln
3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
Tuesday,
July 23, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: John E Lincoln
Dietary Supplements CGMPS - 21 CFR 111 Compliance
21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs. This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
Tuesday,
August 6, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: John E Lincoln 
