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The FDAnews Webinar Training Pass program offers year-round, unrestricted access to any of the hundreds of webinars listed below. These training programs feature thought leadership and best practices from top consultants, expert speakers and current and former FDA officials.
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Webinar Training Pass
Recorded on: July 8, 2015
Description: CDER Director Dr. Janet Woodcock and OPS Acting Director Dr. Lawrence Yu discuss the FDA's evolving approach to pharmaceutical quality six months after the launch of the Office of Pharmaceutical Quality (OPQ). They cover:
- Why OPQ was formed
- OPQ's "One Quality Voice" value statements
- OPQ's organizational structure
- OPQ's 5 objectives
- Same quality standards for all human drugs
- Science and risk-based regulatory approaches
- Quantitative and expertise-based product quality oversight
- Integration of review, inspections, surveillance, policy and research
- Development and adoption of emerging technology
Presentation: Download the presentation
Speakers: Janet Woodcock, MD, Director, CDER; Dr. Lawrence X. Yu, Acting Director, OPS; Peter Pitts, President, Center for Medicine in the Public Interest
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
On-the-Line Process Analytics
54 minutes
Recorded on: July 7, 2015
Description: Validation and analytics expert Paul Mason discusses benefits and pitfalls of various types of process analytics. Topics include:
- The difference between internal and external validation;
- Two different methods for internal validation and five considerations for external validation;
- How FDA's guidance suggests a shift to a "life-cycle" approach; and
- Three models of chemometric data analysis and when to use them.
Presentation: Download the presentation
Speaker: Paul Mason, Director of Science and Technology Practice, Lachman Consultant Services
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Recorded on: July 2, 2015
Description: Biologics quality control expert Emma Ramnarine and Susan Schniepp of the Parenteral Drug Association (PDA) outline PDA's new Technical Report 68 – Risk-Based Approach for Prevention and Management of Drug Shortages. Topics include:
- How to apply a proactive risk-based model at a product level to identify drug shortage risks due to manufacturing and quality issues;
- Best practices to write and enforce the kind of plans prescribed in TR 68 using examples and standard templates; and
- Conducting internal audits to determine if your current controls are properly designed to address drug shortage risks.
Presentation: Download the presentation
Speakers: Emma Ramnarine, Senior Director, Head of Global Biologics QC Network, Roche Pharma, and Susan Schniepp, Chair of Regulatory Affairs/Quality Advisory Board, Parenteral Drug Association
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Understanding CSV Requirements
81 minutes
Recorded on: July 1, 2015
Description: Pharmaceutical consultant Gaurav Walia presents the fundamental steps and common pitfalls of writing user requirements specifications that can be easily validated. He covers:
- The 3 levels of URS and when you need them;
- 10 "Dos" and 3 "Don'ts" for writing URS;
- Top 8 pitfalls for requirements; and
- Upcoming FDA guidance and the impact it will have on computer systems validation.
Presentation: Download the presentation
Speaker: Gaurav Walia, Independent Pharmaceutical Industry Consultant
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Recorded on: June 30, 2015
Description: Clinical trial recruitment expert Matt Miller shares his experiences using digital and social media campaigns to recruit clinical trial participants. He discusses:
- Where patients search for clinical trial information online;
- How to review your social media efforts to make them more effective;
- The importance of social media sharing and how it can supercharge your recruiting efforts; and
- How to tell if you're overspending on your social media campaigns.
Presentation: Download the presentation
Speaker: Matt Miller, Associate Director of Marketing, CRO WCCT Global
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Recorded on: June 23, 2015
Description: Device cybersecurity experts Melissa Masters and Stephanie Preston explain how to improve your quality assurance testing to ensure your devices cannot be compromised by malware or deliberate hacking. Topics include:
- Why and how hackers find vulnerabilities and target medical devices;
- The elements of an effective, cross-functional cybersecurity team; and
- Policies and procedures companies may consider to prepare for the FDA's upcoming release of post-market surveillance expectations.
Presentation: Download the presentation
Speakers: Melissa Masters, Director, Battelle DeviceSecure™ Services; Stephanie Preston, Senior Medical Device Security Engineer, Battelle
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Success Strategies for Biosimilars Approval
82 minutes
Recorded on: June 23, 2015
Description: Intellectual property attorneys Kevin Nelson and Dr. Patrick Gallagher demonstrate how to use the FDA's guidance and prior decisions to greatly improve your chances of getting your 351(k) biosimilar applications approved. They cover:
- How to establish a step-wise approach to product development — the way the FDA prefers;
- The agency's "totality of evidence" methodology for assessing 351(k) applications;
- Using foreign reference products and the need for bridge studies; and
- How analytics should be designed for pharmacokinetics and pharmacodynamics.
Presentation: Download the presentation
Speakers: Kevin Nelson, Partner, and Dr. Patrick Gallagher, Associate, Intellectual Property Practice Group, Duane Morris LLP
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
New Standards for Excipient GMPs
76 minutes
Recorded on: May 27, 2015
Description: GMP expert James Morris explores the newly released NSF/IPEC/ANSI 363-2014 standard for makers of excipient products. Topics include:
- 9 requirements for certifying every batch of excipient passes cGMP requirements;
- 6 key procedures for auditing suppliers;
- Best practices for working with suppliers to assure proper and timely reporting of customer complaints; and
- The latest on if/when the FDA might adopt this as official guidance.
Presentation: Download the presentation
Speaker: James Morris, Executive Director, Pharma Biotech Consulting, NSF Health Sciences
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Device Patent Law Changes
73 minutes
Recorded on: May 27, 2015
Description: Intellectual property law attorney Jonathan Losk discusses new court rulings and significant changes in intellectual property law that could impact you and your business. Topics include:
- How to assess the adequacy of your product's patent protections;
- How to address unsolicited disclosures and manage joint inventions;
- How to best respond to theft of intellectual property; and
- The newest interpretations of infringement by inducement.
Presentation: Download the presentation
Speaker: Jonathan Losk, Partner, Knobbe Martens
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Mathematics of Sterilization
89 minutes
Recorded on: May 21, 2015
Description: Consultant Jerry Dalfors presents various approaches for validating, monitoring and controlling sterilization processes. Topics include:
- How to use survivor curves, to determine D-values and Z-values;
- Calculation of process lethality;
- Which biological indicators to use and how to make the selection; and
- What laboratory studies are best for supporting sterilizer studies.
Presentation: Download the presentation
Speaker: Jerry Dalfors, Principal, JD Technologies
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.