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The FDAnews Webinar Training Pass program gives you year-round unrestricted access to any of the hundreds of webinars listed below. These training programs feature top consultants, expert speakers and FDA officials.
PLUS, subscribers get automatic access to all our new training programs for the next 12 months – that’s more than 50 new programs a year!
If you are already a Training Pass member login below and then scroll down to view the list in date order or narrow your search by keyword or category. Viewing the webinar is easy… simply identify the webinar you want to watch, click on the title and the video will begin. If you would like to view or download the presentation materials separately from the video click the "Download Presentation" link.
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Webinar Training Pass
Recorded on: Dec. 9, 2021
Description: Pharmacovigilance issues? Poor drug safety monitoring or inadequate adverse event reporting can have devastating consequences for patients — and for you. You’ll learn:
- Why pharmacovigilance matters;
- How to comply with premarket and postmarket adverse event reporting requirements;
- How the FDA uses reports to detect safety signals and how it makes drug safety information available to the public; and
- When and why there is a phase 4 (postapproval) study requirement for drugs subject to accelerated approval.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Beth Packman Weinman, Counsel, Member of Ropes & Gray’s Life Sciences Regulatory and Compliance Practice Group
Recorded on: Dec. 9, 2021
Description: Pharmacovigilance issues? Poor drug safety monitoring or inadequate adverse event reporting can have devastating consequences for patients — and for you. You’ll learn:
- Why pharmacovigilance matters;
- How to comply with premarket and postmarket adverse event reporting requirements;
- How the FDA uses reports to detect safety signals and how it makes drug safety information available to the public; and
- When and why there is a phase 4 (postapproval) study requirement for drugs subject to accelerated approval.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kent Malmros, Senior Director, Veeva Systems; and Graham O'Keeffe, General Manager, Veeva Systems
Recorded on: Dec. 8, 2021
Description: Archana Sah, senior vice president of DCT Solutions, Medable and Luisa Sansalone, past clinical research manager at Austin Cancer Center uncover best practices and strategies for developing and deploying decentralized models in oncology trials, including:
- Which oncology protocols are best suited for decentralized clinical trials (DCT);
- Common-use cases for using decentralized methods and technology in oncology;
- Benefits of using a DCT platform purpose-built by clinicians, technology experts and patient advocates who represent the oncology community; and
- Regulatory guidance on hybrid/decentralized trial design.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Archana Sah, Senior Vice President, DCT Solutions, Medable, Inc.; and Luisa Sansalone, Current Clinic Supervisor, Austin Neuromuscular Center
Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections
87 minutes
Recorded on: Dec. 7, 2021
Description: Get control of your data by learning the basics of developing best practices and SOPs that turn inspection nightmares into routine management tasks. You’ll cover:
- The legal basis of FDA records access authority, including what FDA can’t access;
- Types of documents commonly requested during inspections;
- Problems and pitfalls to avoid; and
- The Top 10 questions to ask about your archival process.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: David L. Chesney, Principal, General Manager, DL Chesney Consulting, LLC
Recorded on: Nov. 30, 2021
Description: Will you know what to do when CDRH issues its Quality System Regulation (QSR) proposed rule? This webinar explains:
- What the most significant changes in the proposed rule will be;
- The anticipated timing for the final rule and expectations for compliance;
- Key changes devicemakers must make to their quality systems; and
- What the implications will be for risk management processes in general.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Julie Larsen, Principal and COO, BioTeknica
Recorded on: Nov. 11, 2021
Description: Connie Hoy of Hoy & Associates Regulatory Consulting, shares lessons learned from successfully leading companies through the MDSAP preparation and audit process and provides insights into what you must know and do to obtain certification, including:
- How to prepare successfully using the MDSAP Companion Document;
- How to ensure your quality system completely covers specific country requirements;
- What to expect in the audit’s registration review portion; and
- How the MDSAP audit is conducted and how differs from an FDA inspection or ISO audit.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Connie Hoy, Consultant, Hoy & Associates Regulatory Consulting
Recorded on: Nov. 9, 2021
Description: Cleaning and disinfecting expert Jim Polarine shares tips on how to best design a risk-based cleaning and disinfectant program during the global health crisis, including:
- International and domestic regulatory expectations;
- Guidance documents — USP 43 <1072>, PDA Technical Report #70, the new guidance in Draft Annex I and other industry documents;
- Cleaning and disinfection frequencies;
- Industry best practices; and
- The latest advances in application equipment and cleaning methods.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jim Polarine, Senior Technical Service Manager, STERIS Corporation
Master Your Clinical Trial Budgets: A Step-by-Step Guide to Smarter Clinical Expense Planning
55 minutes
Recorded on: Oct. 28, 2021
Description: Clinical trial management expert Irina Petrova, MD, director of clinical operations at OCT Clinical, shares how to navigate the intricacies of successful clinical trial budgeting and explain every line item, providing:
- A complete checklist of hidden expenses and guidance on where to find them;
- A market overview: outsourcing to CROs in emerging markets;
- Real-world case studies illustrating successful budgeting; and
- Case studies highlighting the impact of the pandemic on budgets.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Irina Petrova, Director of Clinical Operations, OCT Clinical; and Polina Shatrova, Business Development Director, OCT Clinical
Five Steps to TMF “Inspection Readiness”
64 minutes
Recorded on: Oct. 27, 2021
Description: Clinical operations and systems experts Ken Lownie and Janine Penman discuss the benefits and process of bringing an eTMF application into your organization. They explain:
- Requirements of Being “Inspection Ready”;
- The benefits of an eTMF application; and
- Five key capabilities of a successful eMTF application.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Ken Lownie, General Manager, U.S. Operations; and Janine Penman, CEO, JPScientific, Inc.
Recorded on: Oct. 20, 2021
Description: Tim Fischer, principal partner at Great Solutions, shares how to optimize supplier performance at every stage, enabling you to:
- Select suppliers more effectively;
- Simplify supplier qualification;
- Ensure faster vetting of supplier delivery capabilities; and
- Conduct first-shipment inspections based on predetermined specifications.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Tim Fischer, Principal Partner, Great Solutions
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