Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 700817

This webinar will discuss the basic principles of P&PC, specifically as required by the FDA. Also attendees will learn the ISO 13485 and risk analysis / management requirements to evaluate the chief areas of an FDA CGMP compliance inspection / audit to locate areas for implementation and improvement in P&PC.

26 / Jan / 2022 - Wednesday

* Per Attendee $229

 

Risk-based Design Control - The New Paradigm for Medical Device Design

webinar-speaker   Jose Mora

webinar-time   60 Min

Product Id: 706095

In this webinar, learn about the 2019 approach to compliant design control, how to create, manage, and maintain the information found in the various Risk Management documents and files. Get insights about how to shrink documentation time to provide enough time for actual risk management and mitigation.

4 / Feb / 2022 - Friday

* Per Attendee $229

 

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

webinar-speaker   Ginette M Collazo

webinar-time   60 Min

Product Id: 704210

This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.

8 / Feb / 2022 - Tuesday

* Per Attendee $229

 

Design Control for Medical Devices: Overview and Design Inputs

webinar-speaker   Alan M Golden

webinar-time   60 Min

Product Id: 706618

Overview of Design Control for Medical Devices, with an emphasis on design inputs. Seminar will go over regulations, basic concepts in design control and importance of design inputs and how to write appropriate inputs.

10 / Feb / 2022 - Thursday

 

Good Documentation Guideline (Chapter <1029> USP)

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705130

This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.

15 / Feb / 2022 - Tuesday

* Per Attendee $249

 

Supplier Management: Challenges and Opportunities

webinar-speaker   Jeff Kasoff

webinar-time   60 Min

Product Id: 700193

Attend this webinar to learn the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation, including “critical” suppliers and outsourced processes. The QSR and ISO requirements for supplier assessment will be defined as well. The webinar will discuss the application of a risk-based process resulting in a customized supplier management system.

23 / Feb / 2022 - Wednesday

* Per Attendee $229

 

Design Control for Medical Devices Including Verification/Validation

webinar-speaker   Alan M Golden

webinar-time   60 Min

Product Id: 706619

Overview of design control for medical devices with and emphasis on verification and validation of design inputs. Webinar will cover basic regulations regarding verification/validation of inputs, trace of inputs to verification/validation and techniques including statistics for proper verification/validation of design inputs.

24 / Feb / 2022 - Thursday

* Per Attendee $229

 

Human Errors in GMP Manufacturing and Laboratory Processes Identification, Correction and Prevention, Latest FDA Regulatory Requirements & Most Common GMP Issues Caused by Human Error

webinar-speaker   Charles H Paul

webinar-time   120 Min

Product Id: 706786

This instructor-led live training webinar will discuss regulatory requirements for detecting, correcting and preventing human errors in manufacturing and laboratory environments as well as developing a competent, effective corrective and preventive action system.

24 / Feb / 2022 - Thursday

* Per Attendee $299

 

US FDA Medical Device QSR, 21 CFR 820 and Quality Management System

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 705794

Learn the basic overview of the original medical device Quality Management System -- The US FDA’s CGMP, Quality System Regulation (QSR) under 21 CFR 820. Implementation, training requirements and content, and annual internal audit / inspection expectations. The FDA’s four key areas of compliance under QSIT.

1 / Mar / 2022 - Tuesday

* Per Attendee $199

 

How to Prepare a Standard Operating Procedure (SOP)?

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705131

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.

8 / Mar / 2022 - Tuesday

* Per Attendee $199

 

FDA's Ambitious Regulation of Social Media

webinar-speaker   Casper Uldriks

webinar-time   60 Min

Product Id: 703853

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

15 / Mar / 2022 - Tuesday

* Per Attendee $229

 

Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

webinar-speaker   Frank Stein

webinar-time   3 Hrs

Product Id: 706565

This course will give an introduction into the Medical Device Single Audit Program (MDSAP) and how to adjust your internal audit program. The introduction will give an overview about the requirements for the quality management system and how to conduct an internal audit with MDSAP requirements to check, if your quality management system meet all MDSAP requirements.

21 / Mar / 2022 - Monday

* Per Attendee $399

 

ANDA Submission and GDUFA Guidance

webinar-speaker   Charles H Paul

webinar-time   60 Min

Product Id: 706791

An ANDA is an Abbreviated New Drug Application. This application is submitted to the FDA to seek approval to produce a U.S. generic drug from an existing patented approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs. After approval, the applicant is able to produce and market the generic drug product.

23 / Mar / 2022 - Wednesday

* Per Attendee $199

 

Project Management for FDA-Regulated Companies

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 701758

This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.

30 / Mar / 2022 - Wednesday

* Per Attendee $199

 

Supplier Quality Remediation using Principles of Lean Documents and Lean Configuration

webinar-speaker   Jose Mora

webinar-time   90 Min

Product Id: 706777

Based on lean manufacturing and documentation concepts, this webinar deconstructs the supplier quality remediation process.

Recording Available

 

Supplier Management with the new Medical Device Regulation EU MDR 745/2017

webinar-speaker   Frank Stein

webinar-time   90 Min

Product Id: 706068

In this webinar, learn how to implement the changes required by the new regulation EU MDR 745/2017 in your current quality management system in a simple and quick way. The information in this course is vital to your passing the Quality Management Audit by your certification company or notified body.

Recording Available

* Per Attendee $299

 

Validation Sampling Plans

webinar-speaker   Alan M Golden

webinar-time   60 Min

Product Id: 706332

This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation will also be presented.

Recording Available

* Per Attendee $299

 

Process Validation Requirements & Compliance Strategies

webinar-speaker   Jose Mora

webinar-time   60 Min

Product Id: 700162

This webinar on Process Validation Requirements will go over the foundations of process validation, with an emphasis on going beyond compliance to achieve a robust process. Review of the fundamentals of process validation, with an emphasis on looking beyond compliance to achieve a robust process.

Recording Available

* Per Attendee $299

 

Introduction to Medical Device Quality System Regulations

webinar-speaker   Paul Larocque

webinar-time   90 Min

Product Id: 706648

In this webinar, you will get an overview of FDA’s medical device Quality System Regulation, 21 CFR Part 820.

Recording Available

* Per Attendee $299

 

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 703875

This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes.

Recording Available

* Per Attendee $299

 

 

 

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