Keith Gibbs speaker of compliance global

26
Wed
Apr, 2017

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 amore...

Carl Patterson speaker of compliance global

11
Thu
May, 2017

Speaker: Carl Patterson
Duration: 90 Minutes
Product ID: 700717

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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 maintainedmore...

Rachelle D’Souza speaker of compliance global

11
Thu
May, 2017

Speaker: Rachelle D’Souza
Duration: 60 Minutes
Product ID: 700715

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Cosmetic Testing for US FDA Compliance

The US Food and Drug Administration (FDA) hold cosmetic manufacturers and distributors responsible for the safety and quality of their cosmetics. This webinar serves to guide cosmetic manufacturersmore...

Kenneth Christie speaker of compliance global

16
Tue
May, 2017

Speaker: Kenneth Christie
Duration: 90 Minutes
Product ID: 700709

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Understanding FDA Auditing Practices and the Top 10 Most Common Cited Drug GMP Deficiencies for 2015-2016

The success of getting through any audit by federal regulators and third party auditors is not only dependent on a well prepared training of all staff and department employees, but also in knowing more...

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

16
Tue
May, 2017

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 probmore...

Jeff Kasoff speaker of compliance global

22
Mon
May, 2017

Speaker: Jeff Kasoff
Duration: 60 Minutes
Product ID: 700713

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Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacmore...

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...

Rachelle D’Souza speaker of compliance global

07
Wed
Jun, 2017

Speaker: Rachelle D’Souza
Duration: 60 Minutes
Product ID: 700723

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FDA Regulation, 3D Printing and Medical Devices

This webinar on 3D printing will cover FDA's expectations regarding the design, manufacture, testing and approval of 3D printing medical devices.more...

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...

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: 700009

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U.S. FDA's Latest "Strategic Priorities" Initiative - 2014 - 2018

The FDA has added a "Strategic Priorities" initiative that can assist companies to proactively address areas of GMP concern. This webinar discusses their latest / second “Priorities”, f 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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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...

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...

Richard Chamberlain speaker of compliance global

Speaker: Richard Chamberlain
Duration: 60 Minutes
Product ID: 700050

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IRB and Other Committees for Smooth Clinical Trial Conducts

This webinar will introduce the participants to some of the committees that are involved or are necessary for the conduct of  clinical trials. The IRB process will normally decide if the trial 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...

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...

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...

Richard Chamberlain speaker of compliance global

Speaker: Richard Chamberlain
Duration: 90 Minutes
Product ID: 700065

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Implementing 21 CFR Part 11 - What is Computer Systems Validation and how to Implement it.

This system validation webinar training by the expert speaker will cover the Computer Systems Validation Regulations and then cover how a company complies with those regulations when they implement 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...

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...

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...

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...

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...

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...

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...

Carolyn Troiano speaker of compliance global

Speaker: Carolyn Troiano
Duration: 60 Minutes
Product ID: 700421

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Good Documentation Practices to Support FDA Computer System Validation

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotech 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...

Edwin Waldbusser speaker of compliance global

Speaker: Edwin Waldbusser
Duration: 60 Minutes
Product ID: 700437

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Human Factors and Usability Studies

Human Factors Usability is the analysis of how people interact with medical devices and medical device risk analysis. The various types and methods of human factors analysis will be explained. This 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: 700440

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Advanced Auditing for Data Integrity

Any successful records management plan will start with a benchmark assessment of your current state followed by a data integrity audit. more...

Charles H. Pierce speaker of compliance global

Speaker: Charles H. Pierce
Duration: 90 Minutes
Product ID: 700463

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Protocol Deviations and Violations:The importance of knowing how to prevent them

With the increasing frequency of real-time FDA audits, the importance of the nature and frequency of evidence of “Not following the Protocol” has gained increasing importance. Protocol 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...

Carolyn Troiano speaker of compliance global

Speaker: Carolyn Troiano
Duration: 90 Minutes
Product ID: 700514

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Trial Master File (TMF): FDA Expectations from Sponsors and Sites.

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be store 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...

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...

Edwin Waldbusser speaker of compliance global

Speaker: Edwin Waldbusser
Duration: 60 Minutes
Product ID: 700486

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How to prepare for and host a FDA inspection and respond to 483’s

FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483 warning letter than a disorganized company. 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...

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...

Danielle DeLucy speaker of compliance global

Speaker: Danielle DeLucy
Duration: 60 Minutes
Product ID: 700679

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Effective Batch Record Review

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures 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...