Kenneth Christie speaker of compliance global

11
Tue
Apr, 2017

Speaker: Kenneth Christie
Duration: 90 Minutes
Product ID: 700695

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Effective Environmental Monitoring Program: Best Practices in Bio/Pharmaceutical Production

Recent consent decrees have highlighted the importance that the FDA has put on environmental monitoring as a way of verifying control of the operational environment, along with the expectations whemore...

Carolyn Troiano speaker of compliance global

12
Wed
Apr, 2017

Speaker: Carolyn Troiano
Duration: 90 Minutes
Product ID: 700697

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Customs-Trade Partnership Against Terrorism (C-TPAT) Supply Chain Security and Compliance for Regulated Industries

The Customs-Trade Partnership Against Terrorism (C-TPAT) is a voluntary supply chain security program led by U.S. Customs and Border Protection (CBP).  It is intended to improve the security omore...

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: 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 maintainedmore...

Matthew George speaker of compliance global

01
Thu
Jun, 2017

Speaker: Matthew George
Duration: 60 Minutes
Product ID: 700663

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Applying the GAMP® 5 Guide: A Risk Based Approach to Process Control System in Pharmaceutical and Bio-Pharmaceutical Companies

This highly interactive Seminar/Workshop gives the participants experience and practical techniques and solutions to solve PLC/SCADA and Vision Systems Validation compliance challenges.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...

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...

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...

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...

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...

Jerry Dalfors speaker of compliance global

Speaker: Jerry Dalfors
Duration: 60 Minutes
Product ID: 700176

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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...

Adriaan Fruijtier speaker of compliance global

Speaker: Adriaan Fruijtier
Duration: 60 Minutes
Product ID: 700193

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Development regulatory affairs for Oncology Medicinal Products

Because malignant tumours are life-threatening, the death rate from these diseases is high, and existing therapies have limited effectiveness, it is desirable to provide new, effective anticancer d 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...

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...

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...

Roger Cowan speaker of compliance global

Speaker: Roger Cowan
Duration: 60 Minutes
Product ID: 700338

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HVAC and GMP Environmental Control - for Pharmaceutical Clean Rooms

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, micro-organisms, temperature, humidity, more...

Randy Goodden speaker of compliance global

Speaker: Randy Goodden
Duration: 60 Minutes
Product ID: 700372

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Preventing Recalls & Product Liability in New Product Development

Some products in specific industries, such as consumer products, automotive, food and pharmaceutical have to be designed and manufactured keeping that industry’s regulatory compliance require 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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...