Live Webinars Recorded Webinars
  • 12
  • November
  • 2019
  • Tuesday
10:00 AM PST | 01:00 PM EST

Project Management for FDA-Regulated Companies

This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.

John E Lincoln John E Lincoln | Duration:60 Minutes | Price: $150.00 View Details
  • 13
  • November
  • 2019
  • Wednesday
10:00 AM PST | 01:00 PM EST

Root Cause Analysis - Starting at the Beginning

CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.

John E Lincoln John E Lincoln | Duration:60 Minutes | Price: $150.00 View Details
John E Lincoln

Root Cause Analysis - Starting at the Beginning

CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John E Lincoln

EU ISO 13485:2016 Medical Device Quality Management System

This webinar will examine the basic elements of the EU's QMS, ISO 13485, how to implement, areas of major concern and regulatory expectations, and how the system works together. It will examine the underlying causes for major regulated medical device industry QMS failings, as well as how ISO 13485 interfaces with the EU MDR (Medical Device Regulation).

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John E Lincoln

Project Management for FDA-Regulated Companies

This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
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.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
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.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

3-Hour Virtual Seminar on DHF, DMR, DHR, TF , Design Dossiers - The Requirements

This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF including its derivative documents, the DMR and DHR.

Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
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.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
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".

Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
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.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
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.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
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.

Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
John E Lincoln

3-Hour Virtual Seminar on DHF, DMR, DHR, TF , Design Dossiers - The Requirements

This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivative 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.

Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
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.

Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
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.

Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
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.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
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.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.

Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
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".

Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
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.The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if "risk-based".How can this be done in the "real world".

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
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".

Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
John E Lincoln

DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions

This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
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.The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if "risk-based".How can this be done in the "real world"

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

The 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.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
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".

Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
John E Lincoln

CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.

Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
John E Lincoln

Change Control - The Achilles Heel of cGMP Compliance

The last few years have seen an increase in product recalls. For this and other reasons, the U.S. FDA come under increasing negative public scrutiny.

Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
John E Lincoln

The Most Common Problems in FDA Software Validation & Verification

This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.

Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
John E Lincoln

Drafting a Software V&V Documentation Package and Protocol

The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA.

Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
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".

Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
John E Lincoln

DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions

This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

The 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.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.

Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
John E Lincoln

Setting Up and Running a Tougher Supplier Audit Program

The last few years have seen the U.S. FDA come under increasing negative public scrutiny. High profile drug recalls, food chain problems and contamination, import problems, resignations. Now a new commissioner vows no more "business as usual". Data in submissions and decisions rendered will be more science based.

Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
John E Lincoln

Product Risk Management - ISO 14971:2007

This webinar will address the use of the ISO 14971 model to perform and document such activities and the additional actions necessary to make it a useful product reference and training tool.

Speaker: John E Lincoln | View Anytime | Price: $137.00 | View Details
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".

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $141.00 | View Details
John E Lincoln

Meeting Annual U.S. FDA cGMP Training Requirements

There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $162.00 | View Details
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".

Speaker: John E Lincoln | View Anytime | Price: $189.00 | View Details
John E Lincoln

Developing the Master V&V Plan to Meet U.S. FDA, ISO 13485 and 14971 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.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $147.00 | View Details
John E Lincoln

DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
John E Lincoln

Design Controls - Requirements for Medical Device Developers

This webinar will discuss the 9 required elements of a Design Control System. It will consider different methods of implementation, and expectations of the U.S. FDA, proven by documentation.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
John E Lincoln

CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $189.00 | View Details
John E Lincoln

Avoid Warning Letters in View of the U.S. FDA's Stated Goal

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.

Speaker: John E Lincoln | View Anytime | Price: $189.00 | View Details
John E Lincoln

"Zero Defects" and the cGMPs - Pros and Cons

U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices (CGMPs) as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/211, and 820).

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
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".

Speaker: John E Lincoln | View Anytime | Price: $189.00 | View Details
John E Lincoln

Change Control - Key to Successful cGMP Compliance

There is a continuing pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call for change has on a company and its change control policies and systems.

Speaker: John E Lincoln | View Anytime | Price: $189.00 | View Details
John E Lincoln

Compiling the Design History File, and Technical File, Design Dossier

This webinar will examine both the FDA and MDD regulatory expectations for the respective DHF and TF / DD. It will discuss the major sections of both, common elements and differences, what must be included and what should be included, and how the information should be compiled and presented.

Speaker: John E Lincoln | View Anytime | Price: $189.00 | View Details
John E Lincoln

The 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.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details