Edwin Waldbusser speaker of compliance global

07
Wed
Jun, 2017

Speaker: Edwin Waldbusser
Duration: 60 Minutes
Product ID: 700675

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Hazard Analysis following ISO 14971

The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognimore...

Carolyn Troiano speaker of compliance global

13
Tue
Jun, 2017

Speaker: Carolyn Troiano
Duration: 90 Minutes
Product ID: 700730

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Best Validation Practices for Laboratory Computer Systems Regulated by FDA

We will discuss the importance of applying industry best practices when validating laboratory systems that are regulated by FDA.  Any “GxP” system (i.e., the system "touches" produmore...

Ginette M. Collazo, Ph.D speaker of compliance global

14
Wed
Jun, 2017

Speaker: Ginette M. Collazo, Ph.D
Duration: 90 Minutes
Product ID: 700734

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Measuring And Understanding Cognitive Overload And Human Error

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance probmore...

José Mora speaker of compliance global

21
Wed
Jun, 2017

Speaker: José Mora
Duration: 90 Minutes
Product ID: 700735

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Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Test method validation is an often-confusing requirement for medical devices.  A fundamental issue is the role-reversal between the test method and the product or process it is designed to detmore...

Lena Cordie speaker of compliance global

21
Wed
Jun, 2017

Speaker: Lena Cordie
Duration: 60 Minutes
Product ID: 700738

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Update on Global UDI Initiatives for Medical Devices

This webinar will provide updates on the progress of unique device identification regulations around the world, including the status of the FDA’s implementation, requirements for UDI in the nmore...

Rachelle D’Souza speaker of compliance global

05
Wed
Jul, 2017

Speaker: Rachelle D’Souza
Duration: 60 Minutes
Product ID: 700744

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Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations

If you are a sponsor of a clinical trial involving a drug, biologic, medical device or combination product, a clinical investigator, a contract research organization (CRO) or an institutional reviemore...

David R Dills speaker of compliance global

Speaker: David R Dills
Duration: 60 Minutes
Product ID: 700235

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Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements

Any Medical Device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only app more...

Charles H. Pierce speaker of compliance global

Speaker: Charles H. Pierce
Duration: 90 Minutes
Product ID: 700002

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Criticality of Laboratory Data - including EKG - in the Drug Development Process

With the increasing frequency of real-time FDA audits and complexity of Investigational Medicinal Products (IMP’s), the wise are paying more attention to including a full range of lab tests t more...

Jerry Dalfors speaker of compliance global

Speaker: Jerry Dalfors
Duration: 60 Minutes
Product ID: 700006

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CAPA Training and Causes of Warning Letters due to Lack of Comprehension

CAPA (Corrective and Preventative Actions) did not originate in the Pharmaceutical and Medical Device industry or the Automobile Industry as most folks post on the Internet.  The program to ma more...

John E.  Lincoln speaker of compliance global

Speaker: John E. Lincoln
Duration: 90 Minutes
Product ID: 700015

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The Best Way to Develop or Improve a Master Validation Plan

How to develop or improve upon a Master Validation Plan / Validation Master Plan or System that meets U.S. FDA CGMP, ICH Q-series, and ISO 13485 expectations and requirements.FDA Warnin more...

Les Schnoll speaker of compliance global

Speaker: Les Schnoll
Duration: 90 Minutes
Product ID: 700018

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José Mora speaker of compliance global

Speaker: José Mora
Duration: 90 Minutes
Product ID: 700027

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21 CFR Part 820 - Applying Principles of Lean Documents and Lean Configuration

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. more...

Jerry Dalfors speaker of compliance global

Speaker: Jerry Dalfors
Duration: 90 Minutes
Product ID: 700029

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Generation of Controlled Documents and Related Training

The purpose of this webinar is to provide the topics and basic instructions needed to establish the good documentation practices training needed to meet or exceed compliance expec more...

Michael Brodsky speaker of compliance global

Speaker: Michael Brodsky
Duration: 60 Minutes
Product ID: 700032

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Root Cause Analysis (RCA) and its Benefits

Root Cause Analysis (RCA) is a popular and oft more...

José Mora speaker of compliance global

Speaker: José Mora
Duration: 90 Minutes
Product ID: 700041

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Traceability Matrix - Principles of Lean Documents and Lean Configuration

Design control process involves the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs.  These design inputs then form the basis more...

Jerry Dalfors speaker of compliance global

Speaker: Jerry Dalfors
Duration: 90 Minutes
Product ID: 700048

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Process Validation in Statistical Process Control

The ultimate goal of FDA Process Validation is to ensure continual assurance that the process once initially validated (PQ now PPQ) and submitted for FDA/EU approval remains in a state of control b more...

Dr. David Lim speaker of compliance global

Speaker: Dr. David Lim
Duration: 60 Minutes
Product ID: 700078

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Best Practices for FDA-Compliant Cybersecurity Management for Premarket Submissions of Medical Devices.

This webinar is intended to help you get familiar with the FDA-compliant management of medical device cybersecurity for regulatory purposes.This webinar is further intended to increase more...

Dev Raheja speaker of compliance global

Speaker: Dev Raheja
Duration: 60 Minutes
Product ID: 700054

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Process Validation with a Product Lifecycle Concept to Meet FDA Requirements

Process validation training activities with a product lifecycle management concept and the FDA risk management framework is critical for the medical device industry, because most of the device fail more...

Jerry Dalfors speaker of compliance global

Speaker: Jerry Dalfors
Duration: 90 Minutes
Product ID: 700057

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PRINCIPLES, AND PRACTICAL ASPECTS OF LYOPHILIZATION TECHNOLOGY

Lyophilization, commonly referred to as freeze drying equipment, is the process of removing water from a product by sublimation and desorbtion.  This process is performed in lyophilization equ more...

José Mora speaker of compliance global

Speaker: José Mora
Duration: 90 Minutes
Product ID: 700059

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Creation of Unique DHFs, DMRs, and DHRs using the Principles of Lean

The Theory of Document Management system is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. more...

José Mora speaker of compliance global

Speaker: José Mora
Duration: 75 Minutes
Product ID: 700082

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Corrective and Preventive Action utilizing the theory of Lean Documents.

The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lea more...

José Mora speaker of compliance global

Speaker: José Mora
Duration: 60 Minutes
Product ID: 700068

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A Fresh Approach to Controlled Document System using Principles of Lean Documents and Lean Configuration.

All life science industry businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of r more...

Jerry Dalfors speaker of compliance global

Speaker: Jerry Dalfors
Duration: 90 Minutes
Product ID: 700072

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Mathematics of Terminal Sterilization - Survival vs Overkill Approach.

Different microorganisms in different environments during sterilization have different resistance to the destructive principles that causes the organism or spore to die (lethality). Some extreme th more...

John E.  Lincoln speaker of compliance global

Speaker: John E. Lincoln
Duration: 90 Minutes
Product ID: 700045

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Software Verification and Validation in Medical Industry

The verification and validation of medical industry software is coming under increased scrutiny by the U.S. FDA.  This webinar will address the use of the FDA, GAMP, 21 CFR 11, and other appli more...

Larry Spears  speaker of compliance global

Speaker: Larry Spears
Duration: 60 Minutes
Product ID: 700084

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Registration & Listing, FDA Inspection Strategies and Compliance Initiatives - Medical Device.

Have you ever wondered about the FDA strategies for scheduling inspections and pursuing compliance plans?  This seminar will provide clarity around those issues from a compliance expert with o more...

Michael  Ellerby  speaker of compliance global

Speaker: Michael Ellerby
Duration: 90 Minutes
Product ID: 700085

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Reviewing the processes to assess laboratory risks in terms of both Health and Safety.

There is often an assumption that laboratory people know about lab safety. While there is some truth in this, there is still much that can be learned by reviewing and thinking through the processes more...

Robert L. Kunka, Ph. D. speaker of compliance global

Speaker: Robert L. Kunka, Ph. D.
Duration: 60 Minutes
Product ID: 700124

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Paediatric Drug Development - Adult Data and Relevant FDA Laws.

Up until a few years ago FDA required pharmaceutical companies to duplicate the same studies that were required in adults in children. This requirement often prevented development in children becau more...

Larry Spears  speaker of compliance global

Speaker: Larry Spears
Duration: 60 Minutes
Product ID: 700088

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Corrective and Preventive Action (CAPA) and Complaint Handling in Medical Device.

Have you ever wondered about how FDA approaches CAPA (corrective and preventive actions) and complaint issues during inspections? What about how they manage those activities and what they are looki more...

Norma Skolnik speaker of compliance global

Speaker: Norma Skolnik
Duration: 60 Minutes
Product ID: 700172

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FDA Regulations for Marketing OTC Drugs in the U.S.

The webinar will offer an overview of FDA requirements for marketing, labelling and promotion of OTC drugs in the U.S. It will cover how OTC pharmacy can be effectively marketed and the OTC Monogra more...

Larry Spears  speaker of compliance global

Speaker: Larry Spears
Duration: 90 Minutes
Product ID: 700102

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Medical Device Export Approvals and Certificates in compliance with FDA regulations

Firms exporting products from the U.S. are often asked by foreign customers or foreign governments to supply proof of the products’ status as regulated by the FDA. An export certificate is a more...

Marie Dorat speaker of compliance global

Speaker: Marie Dorat
Duration: 90 Minutes
Product ID: 700249

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Unique Device Identifier (UDI) Implementation

This webinar on Unique Device Identifier (UDI) requirements will discuss the new rules implemented by FDA. Attendees will get an overview of the new requirement and how to implement. more...

John E.  Lincoln speaker of compliance global

Speaker: John E. Lincoln
Duration: 90 Minutes
Product ID: 700098

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The FDAs DHF, DMR and DHR Design Dossier for Documentation

The FDA's Design History Files, Device Master Records, Device History Record, and the EU's MDD TF/DD -- Documentation to meet their different purposes and device classifications.  This webinar more...

Philip Vassallo speaker of compliance global

Speaker: Philip Vassallo
Duration: 60 Minutes
Product ID: 700205

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Writing Effective Email

Have you been on the receiving end of an email with an endless, useless recipient list? Have you struggled through the overlong, cryptic prose and twisted logic of an email only to realize you have more...

Les Schnoll speaker of compliance global

Speaker: Les Schnoll
Duration: 90 Minutes
Product ID: 700039

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The Values and Benefits of Medical Device Reporting Compliance

Since the mid 1980s, the FDA has expressed concerns about their need to be informed of adverse events that may have been caused by or contributed to legally marketed medical devices.  As such, more...

Maria Stevens Hardy speaker of compliance global

Speaker: Maria Stevens Hardy
Duration: 60 Minutes
Product ID: 700267

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From the ER to the OR - IQCP Compliance for CAP Accredited Hospitals

In July 2015, the College of American Pathologists (CAP) released their Individualized Quality Control Plan (IQCP). In this iqcp webinar we will review the CAP Guidelines and discuss the IQCP compl more...

Drew Barnholtz speaker of compliance global

Speaker: Drew Barnholtz
Duration: 60 Minutes
Product ID: 700204

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How to Respond to an FDA Investigation: What happens when the FDA threatens to shut you?

FDA investigations can lead to observations requiring remediation, disruption of your business, loss of revenue and enforcement actions up to and including having your plant shutdown.  more...

Roger Cowan speaker of compliance global

Speaker: Roger Cowan
Duration: 60 Minutes
Product ID: 700285

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Pharmaceutical Compressed Air Quality GMP Requirements - What you need to know to meet FDA and International Quality Standards

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction and monit more...

Sarah Fowler-Dixon speaker of compliance global

Speaker: Sarah Fowler-Dixon
Duration: 60 Minutes
Product ID: 700287

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10 Tips for Submitting Human Subjects Protocols

Institutional Review Boards (IRB) also known as ethics committees or ethical review boards were established by federal regulation in 1974. IRBs are independent committees designated to approve, mon more...

Howard  T Cooper speaker of compliance global

Speaker: Howard T Cooper
Duration: 90 Minutes
Product ID: 700221

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Establishing a Reduced Testing Process for Incoming Materials

The first step in reduced testing is to qualify the supplier using the supplier qualification process. This webinar will review the supplier qualification process. The sequential steps for more...

John C. Fetzer speaker of compliance global

Speaker: John C. Fetzer
Duration: 60 Minutes
Product ID: 700305

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Validation of a HPLC/UPLC methodology

Instrumental liquid chromatography (HPLC method development/ UPLC method development) are commonly used in the pharmaceutical, environmental, and other areas for analyses that need to comply with e more...

Norma Skolnik speaker of compliance global

Speaker: Norma Skolnik
Duration: 60 Minutes
Product ID: 700308

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How the FDA & FTC Regulate Advertising & Promotion of Drugs & Dietary Supplements

This webinar will cover FDA regulatory compliance training requirements for all manufacturers and distributors who want to advertise and/or promote OTC drugs list and dietary supplements in the U.S more...

Howard  T Cooper speaker of compliance global

Speaker: Howard T Cooper
Duration: 90 Minutes
Product ID: 700196

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A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences.

This webinar will explore differences and similarities between these GMPs as well as show how they relate to other quality systems, regional regulations, and guidance documents. Examples include IC more...

Edwin Waldbusser speaker of compliance global

Speaker: Edwin Waldbusser
Duration: 60 Minutes
Product ID: 700286

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21 CFR Part 11 Compliance

This Webinar will explain what 21 CFR Part 11 training is, why it is important to c companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling el more...

Carolyn Troiano speaker of compliance global

Speaker: Carolyn Troiano
Duration: 60 Minutes
Product ID: 700346

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Trends in FDA Compliance and Enforcement for Regulated Systems

Pharmaceutical, biological, vaccine, medical device, animal health, tobacco and other companies regulated by FDA must be vigilant in understanding compliance and enforcement by the Agency as it rel more...

John E.  Lincoln speaker of compliance global

Speaker: John E. Lincoln
Duration: 90 Minutes
Product ID: 700348

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21 CFR Part 11: Understanding the ERES Regulation for Compliance Success

The verification and validation of medical industry software used in CGMP compliance records and defined under 21 CFR 11, “Electronic Records / Electronic Signatures” is coming under in more...

Tony Imm speaker of compliance global

Speaker: Tony Imm
Duration: 60 Minutes
Product ID: 700328

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Best Practices for Compliance with FDA 21CFR1040

All manufacturers, system integrators and importers of lasers or laser containing products must comply with FDA regulation training 21CFR1040 with very few exceptions. This is accomplished by a sel more...

Kate Duffy Mazan speaker of compliance global

Speaker: Kate Duffy Mazan
Duration: 90 Minutes
Product ID: 700355

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Negotiating Cooperative Research and Development Agreements (CRADAs) with the US Government

This webinar will provide an overview of Cooperative Research and Development Agreement (CRADA) as a mechanism for working with the federal government. The webinar will review the legislative histo more...

Joy McElroy speaker of compliance global

Speaker: Joy McElroy
Duration: 90 Minutes
Product ID: 700357

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Auditing Quality Suppliers and Vendors

The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. more...

Susanne Manz speaker of compliance global

Speaker: Susanne Manz
Duration: 60 Minutes
Product ID: 700336

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Using Metrics to Monitor and Improve your Quality Management System

Medical Device companies need effective metrics and dashboards to ensure they are proactively and consistently meeting the regulatory compliance training needs for all their stakeholders: C more...

Robert(Bob) H. Crabtree speaker of compliance global

Speaker: Robert(Bob) H. Crabtree
Duration: 60 Minutes
Product ID: 700296

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Palladium Coupling Catalysis

The reaction scope and range of applicable conditions for Palladium Coupling Catalysis are covered to show how to avoid problems and optimize catalysis in typical small to commercial scales applica more...

Howard  T Cooper speaker of compliance global

Speaker: Howard T Cooper
Duration: 90 Minutes
Product ID: 700397

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Establishing a Reduced Testing Process for Incoming Materials

The first step in reduced testing is to qualify the supplier using the supplier qualification process. This webinar will review the supplier qualification process. The sequential steps for more...

Adriaan Fruijtier speaker of compliance global

Speaker: Adriaan Fruijtier
Duration: 60 Minutes
Product ID: 700401

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Pediatric Investigation Plans (PIP) in the EU

The European Medicines Agency plays an important role in the development of medicines for children. In the past, many medicines authorized in Europe were not studied adequately or authorized in chi more...

Howard  T Cooper speaker of compliance global

Speaker: Howard T Cooper
Duration: 90 Minutes
Product ID: 700398

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A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences.

This webinar will explore differences and similarities between these GMPs as well as show how they relate to other quality systems, regional regulations, and guidance documents. Examples include IC more...

Norma Skolnik speaker of compliance global

Speaker: Norma Skolnik
Duration: 60 Minutes
Product ID: 700374

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U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements & Cosmetics

In order to market dietary supplements and OTC drugs list in the U.S., reporting serious adverse events is required. more...

Joy McElroy speaker of compliance global

Speaker: Joy McElroy
Duration: 90 Minutes
Product ID: 700418

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Laboratory Safety: Common Policies & Procedures Guidance

This webinar is designed to teach general practices on safety procedures that should be followed in the laboratory such as providing safety contracts/ SOPs, identifying medical and allergy problems more...

Michael Levin speaker of compliance global

Speaker: Michael Levin
Duration: 60 Minutes
Product ID: 700474

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Life Cycle Process Validation According to FDA and other Standards

This webinar course covers a variety of topics on validation of pharmaceutical product and process according to FDA standards and others. more...

Susanne Manz speaker of compliance global

Speaker: Susanne Manz
Duration: 90 Minutes
Product ID: 700426

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Production and Process Controls for Medical Devices

Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce products. more...

Adriaan Fruijtier speaker of compliance global

Speaker: Adriaan Fruijtier
Duration: 60 Minutes
Product ID: 700342

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Scientific Advice in the EU

Scientific advice helps the company to make sure that it performs the appropriate tests and studies, so that no major objections regarding the design of the orphan indication tests are likely to be more...

Joy McElroy speaker of compliance global

Speaker: Joy McElroy
Duration: 90 Minutes
Product ID: 700500

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Review Electronic Data and Audit Trails

The purpose of an Audit Trail for Electronic Record systems is to provide assurance of the integrity of the Electronic Health Records and the associated Raw Data. Although the FDA has state more...

Norma Skolnik speaker of compliance global

Speaker: Norma Skolnik
Duration: 60 Minutes
Product ID: 700412

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How the FDA & FTC Regulate Advertising & Promotion of Drugs & Dietary Supplements

This webinar will cover FDA regulatory compliance training requirements for all manufacturers and distributors who want to advertise and/or promote OTC drugs list and dietary supplements in the U.S more...

Carl Patterson speaker of compliance global

Speaker: Carl Patterson
Duration: 90 Minutes
Product ID: 700519

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Environmental Monitoring – Knowing your cleanroom

This webinar will provide the proper methods and techniques required to maintain a clean room per FDA and ISO regulations. By the use of viable and non-viable testing, a cleanroom can be maintained more...

Michael Brodsky speaker of compliance global

Speaker: Michael Brodsky
Duration: 60 Minutes
Product ID: 700473

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Quality Control for Analytical Materials used in Microbiology Laboratories

Many laboratories are unsure about which QC practices are needed and what criteria to use to assess the acceptability of the performance of analytical materials, to meet not only their requirements more...

Karl R.  Leinsing speaker of compliance global

Speaker: Karl R. Leinsing
Duration: 60 Minutes
Product ID: 700510

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FDA Chapter 21 CFR Subpart C Section 820.30 – Design Control Requirements

This webinar will discuss why certain steps are so important in the design process and that many steps are not just wasted time and paperwork. The process is a methodical approach that can be used more...

Kate Duffy Mazan speaker of compliance global

Speaker: Kate Duffy Mazan
Duration: 90 Minutes
Product ID: 700555

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Negotiating Cooperative Research and Development Agreements (CRADAs) with the US Government.

This webinar will explore the different types of CRADAs, as well as key contract provisions such as the definition of CRADA subject inventions, the options to license government rights in CRADA Sub more...

Susanne Manz speaker of compliance global

Speaker: Susanne Manz
Duration: 90 Minutes
Product ID: 700493

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Secrets to Writing Effective SOPs for Medical Device QMS

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an ins more...

Meena Chettiar speaker of compliance global

Speaker: Meena Chettiar
Duration: 60 Minutes
Product ID: 700574

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New ISO 13485: Proposed Changes and What They Mean to the Medical Device Industry

You will gain a thorough insight into the quality system requirements of the all new International ISO 13485:2016 Standard requirements for Medical Device single audit program.  This e more...

Adriaan Fruijtier speaker of compliance global

Speaker: Adriaan Fruijtier
Duration: 60 Minutes
Product ID: 700472

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Orphan Medicinal Product Designation in the EU

The European Medicines Agency plays a central role in the development and authorisation of medicines for rare diseases. These medicines are termed ‘orphan medicines’ in the medical worl more...

Harold Thibodeaux speaker of compliance global

Speaker: Harold Thibodeaux
Duration: 90 Minutes
Product ID: 700526

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Research Use Only Products – the Dos and Don’ts

For the past 30 plus years, the label “For Research Use Only” has been confusing to many medical and research professionals as well as marketing and sales personnel.  Addit more...

Dr. Susan Leister speaker of compliance global

Speaker: Dr. Susan Leister
Duration: 90 Minutes
Product ID: 700579

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Are you qualifying your vendors?

Many companies depend upon a vendor or supplier for some product or service and need to ensure compliance.  At the end of the day if the manufacturer fails to ensure oversight of the vendors t more...

Lena Cordie speaker of compliance global

Speaker: Lena Cordie
Duration: 60 Minutes
Product ID: 700608

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Update on Global UDI Initiatives for Medical Devices

This webinar will provide updates on the progress of unique device identification regulations around the world, including the status of the FDA’s implementation, requirements for UDI in the n more...

John C. Fetzer speaker of compliance global

Speaker: John C. Fetzer
Duration: 60 Minutes
Product ID: 700570

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Validation of GC/ GC-MS methodologies

Instrumental gas chromatography, either as GC or GC-MS, are common techniques in laboratories that do regulatory-compliance work. more...

Peggy J. Berry speaker of compliance global

Speaker: Peggy J. Berry
Duration: 90 Minutes
Product ID: 700524

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Phase I GMPs

Early clinical trial phases are conducted to establish initial safety of a drug. The drug trial studies are generally in small number of healthy subjects and use lower doses of the drug product. Th more...

Joy McElroy speaker of compliance global

Speaker: Joy McElroy
Duration: 120 Minutes
Product ID: 700609

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Good Laboratory Practices (GLPs) comparing and contrasting GMPs

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices training. more...

Edwin Waldbusser speaker of compliance global

Speaker: Edwin Waldbusser
Duration: 60 Minutes
Product ID: 700649

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How to conduct a Human Factors and Usability validation following ISO62366 and the new FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation more...

Carolyn Troiano speaker of compliance global

Speaker: Carolyn Troiano
Duration: 90 Minutes
Product ID: 700501

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FDA and EMA Global labeling challenges faced in day-to-day operations

Pharmaceutical companies must manage the process of designing and creating product labels that meet regulatory requirements. This includes product-labeling documents such as Packet Inserts (PIs), S more...

Dr Nigel  Smart speaker of compliance global

Speaker: Dr Nigel Smart
Duration: 90 Minutes
Product ID: 700669

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Effective supplier auditing to maintain a compliant supplier Quality System

This supplier management training sets out the nuts and bolts of what a supplier quality system element should look like and then describes how that is operated practically to conjunction with an e more...

Ronald  D. Snee speaker of compliance global

Speaker: Ronald D. Snee
Duration: 90 Minutes
Product ID: 700605

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Pharma Analytics – I Have All These Data, Now What Do I Do?

We know that it takes more than a large data set and computer software to effectively solve problems. As information technology increases in capability and availability the opportunity to use data more...

Ginette M. Collazo, Ph.D speaker of compliance global

Speaker: Ginette M. Collazo, Ph.D
Duration: 90 Minutes
Product ID: 700692

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Measuring And Understanding Cognitive Overload And Human Error

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance prob more...

José Mora speaker of compliance global

Speaker: José Mora
Duration: 90 Minutes
Product ID: 700701

Purchase

An Advanced Course on Lean Documents, Lean Configuration and Document Control

In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examp more...

Keith Gibbs speaker of compliance global

Speaker: Keith Gibbs
Duration: 90 Minutes
Product ID: 700705

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Lessons Learned in the Design, Installation, Start-Up and Qualification of Clean Compressed Air Systems for cGMP Manufacturing

In the pharmaceutical industry, compressed air is used for a number of production and packaging applications, including blowing off and drying bottles prior to filling, conveying pills, providing a more...

Ginette M. Collazo, Ph.D speaker of compliance global

Speaker: Ginette M. Collazo, Ph.D
Duration: 90 Minutes
Product ID: 700711

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Controlling human error in the manufacturing floor

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance prob more...