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...

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...

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...

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...

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...

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...

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...

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...

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...

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...