WEBINARS

 

FDA Drug and Device Approvals Regulatory Compliance Training - Live Webinars, Recordings & CDs

Classifying Medical Devices - US and EU

webinar-speaker   Charles H Paul

webinar-time   60 Min

Product Id: 705045

The Medical Device Classification webinar explains the classification system in US and the EU.

Recording Available

* Per Attendee $229

 

Drug Pharmacy Compounding

webinar-speaker   Rachelle D Souza

webinar-time   60 Min

Product Id: 704907

This webinar will discuss conditions under which certain compounded human drug products are exempted from compliance with cGMPs, labeling, market approval and reporting requirements. It will cover conditions that require an outsourcing facility to comply and the latest developments in drug pharmacy compounding.

Recording Available

* Per Attendee $249

 

Preparing Stability Protocols for Development and Commercial Products

webinar-speaker   Peggy Berry

webinar-time   90 Min

Product Id: 704459

This training program will discuss the requirements of ICH and the FDA for stability protocol content and format, including special stability studies required for approval.

Recording Available

* Per Attendee $279

 

What You Should Know About Export Requirements for FDA Regulated Products from US to Foreign Countries

webinar-speaker   Rossano V Gerald

webinar-time   60 Min

Product Id: 705186

When exporting outside the U.S., exporters must consider the Food and Drug Administration (FDA) provisions as it helps them understand what documents and procedures are needed in coordination with the transaction process. This training program will provide an in-depth explanation of FDA-regulated products that are exported from the United States to foreign countries. Also, it will address what export documentation must be used in the transportation of FDA-regulated products.

Recording Available

 

How to prepare a 510(k) FDA Submission

webinar-speaker   Edwin Waldbusser

webinar-time   60 Min

Product Id: 705024

This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission.

Recording Available

 

Prospects for Change at FDA Under the Trump Administration: Early View of What 2017 Will Bring

webinar-speaker   Steven Grossman

webinar-time   90 Min

Product Id: 705023

This webinar will discuss FDA's current priorities and the agency's likely priorities and the future of regulations and policies in 2017 under the new Trump administration.

Recording Available

* Per Attendee $199

 

Type 2 DMFs for Active Pharmaceutical Ingredients (APIs)

webinar-speaker   Peggy Berry

webinar-time   90 Min

Product Id: 704882

This webinar will discuss approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will enable completion of the drug substance information in the Drug Master File – in support of Module 3 of a CTD application. The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. Both traditional and enhanced approaches are discussed.

Recording Available

 

Grant Writing - All You Need to Know About Criteria, Parameters, Obligations, Application Structure and Grant Reporting

webinar-speaker   Vidia Ramdeen

webinar-time   60 Min

Product Id: 704550

This training program will help participants identify grant opportunities and get started with the grant writing process. They will gain insight into public/private grants, the grant application process and grant reporting.

Recording Available

 

Pre-Market Submission Implications of FDA’s Human Factors Guidance and Device Priority List

webinar-speaker   Robert A North

webinar-time   90 Min

Product Id: 704551

This training program will explore why human factors has become a vital part of the FDA’s medical device pre-market approval/clearance process. The FDA Center for Devices and Radiological Health (CDRH) recently issued two guidance documents on human factors that are key elements in determining pre-market submission strategies for manufacturers. In this webinar, attendees will learn how to provide clear and complete human factors submissions meeting the intent of these guidance.

Recording Available

* Per Attendee $229

 

FDA Regulations on Usage of New Pharmaceutical Agents to Fight Infection

webinar-speaker   Thomas Webster

webinar-time   2 hrs

Product Id: 704559

This training program will discuss fundamentals of infection and the use of materials/drugs to fight infection, FDA regulatory approvals for drugs and materials used to fight infection, and future thoughts on approaches to fight infection.

Recording Available

 

3-Hour Virtual Training: Russia Regulatory Compliance Requirements for Life Science Products

webinar-speaker   Robert J Russell

webinar-time   3 hrs

Product Id: 704356

This training course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.

Recording Available

* Per Attendee $429

 

How to Properly Monitor Process and Performance of Pharmaceutical Solid Dosage Equipment

webinar-speaker   Michael Levin

webinar-time   60 Min

Product Id: 704274

Among other key topics, this training program will focus on what can be monitored in mixing operations, wet granulation operations, dry granulation operations, compaction operations, and coating operations.

Recording Available

* Per Attendee $229

 

Veterinary Drug Approval Process and FDA's Regulatory Oversight

webinar-speaker   Karl M. Nobert

webinar-time   60 Min

Product Id: 703971

This training program will provide attendees with an introduction to FDA’s veterinary drug approval process. It will also discuss key components of an appropriate animal field study needed to support new animal drug approval and explain how jurisdiction is split between various federal agencies in certain cases.

Recording Available

 

Health Canada’s Enforcement of the Regulatory Requirements for the Manufacture, Advertising and Sale of Pharmaceuticals, Medical Devices and Natural Health Products

webinar-speaker   Sara Zborovski

webinar-time   60 Min

Product Id: 703830

The introduction of Vanessa’s Law in late 2014 has significantly changed the enforcement landscape, providing for the possibility of higher penalties than ever before in Canada. This training program will offer an overview of the new law and its potential impact on industry.

Recording Available

* Per Attendee $229

 

Selecting the Most Appropriate Predicate Device(S) for your 510(k) Application

webinar-speaker   Cheryl Wagoner

webinar-time   60 Min

Product Id: 703438

This webinar will provide tips and techniques on how to research and identify appropriate predicate devices for a 510(k) application.

Recording Available

* Per Attendee $229

 

FDA Premarket Review of New and Modified Tobacco Products

webinar-speaker   Azim Chowdhury

webinar-time   60 Min

Product Id: 703127

This training on FDA regulatory requirements for tobacco products will focus on the premarket review of new and modified tobacco products. It will also discuss the impact of FDA deeming regulation for of e- cigarettes and novel tobacco products on premarket authorization requirements.

Recording Available

* Per Attendee $229

 

Essential Do's and Don'ts for Navigating a Successful 505(b)(2) Drug Application

webinar-speaker   Thomas Reilly

webinar-time   60 Min

Product Id: 703314

This FDA New Drug Approval process training will provide attendees with the knowledge and skills needed to develop a successful 505 (b)(2) program.

Recording Available

* Per Attendee $229

 

3-hr Virtual Seminar: FDA's Establishment Registration and Product Listing Requirements, User Fees, Fee Waivers and Market Exclusivity

webinar-speaker   Karl M. Nobert

webinar-time   3 hrs

Product Id: 703269

This 3-hour training will review and compare FDA’s Establishment Registration and Product Listing Requirements; and available User Fees, Fee Waivers and Marketing Exclusivity for Drugs, Biologics, Medical Devices, Food, Tobacco and Animal Health Products.

Recording Available

* Per Attendee $499

 

Understanding the FDA ''Refuse to Accept'' guidance to avoid administrative rejection of your 510(k)

webinar-speaker   Cheryl Wagoner

webinar-time   60 Min

Product Id: 703235

The webinar will familiarize participants with the FDA's Refuse to Accept Policy for medical device 510(k)’s and help you ensure that your 510(k) application is not rejected for lack of administrative completeness.

Recording Available

* Per Attendee $229

 

 

 

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