Simplifying Global Compliance
The Webinar Training Pass
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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!
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Webinar Training Pass
Recorded on: April 25, 2018
Description: Attorney Eric Babineaux explains the importance of precise wording in clinical trial agreements. He discusses:
- Understanding nuanced and specific contract language;
- The importance of debarment provisions and how to respond to contract qualifiers on debarment certification; and
- Interpreting important indemnification provisions and understanding the differences between “indemnify” and “hold harmless.”
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Eric Babineaux, Legal Counsel, Clintrax Global
Recorded on: April 23, 2018
Description: Cybersecurity specialists Norma Krayem and Michael Werner discuss the rapidly evolving global regulatory landscape. They cover:
- Cybersecurity-triggered changes in interpretation of HIPAA and enforcement by the HHS Office of Civil Rights;
- Cybersecurity as an enterprise risk management issue affecting security, risk and privacy functions in device firms;
- How Department of Homeland Security initiatives, including the Automated Information Sharing (AIS) program, can help you understand the threat from nation-states, non-state actors and other potential attackers; and
- The FDA’s focus on cybersecurity and how it impacts the risk, responsibilities and regulation of companies.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Norma Krayem, Senior Policy Advisor and Co-Chair, Cybersecurity and Privacy Team, Holland & Knight, and Michael Werner, Partner, Holland & Knight
Recorded on: April 19, 2018
Description: Management systems expert Dan O’Leary explains how to comply with U.S. and international standards for personnel training. He discusses:
- The four elements of competency and how to include them in job descriptions;
- The concept and qualifications of a ‘designated individual;’
- Implementing the competence acquisition process using the ISO 10018:2012 model;
- Implementing a training program using the ISO 10015:1999 model; and
- Competence gap analysis and how to close identified gaps.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
Recorded on: April 18, 2018
Description: Attorneys J.J. Saul and Julie Letwat discuss best practices for online pharmacies can protect themselves from e-commerce threats. Topics include:
- How rogue drug websites affect your operation and professional responsibilities;
- Impact on existing laws and regulations;
- How resources such as the Alliance for Safe Online Pharmacies (ASOP) can help you protect yourself;
- The risks consumers run when buying prescriptions and devices online; and
- Working with consumer groups to protect your customers.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: J.J. Saul, Partner, and Julie K.Letwat, Counsel, Faegre Baker Daniels LLP
Recorded on: April 12, 2018
Description: CMC expert Wayland Rushing discusses the regulatory climate surrounding extractables and leachables (E&L), including:
- What they are and the special issues they pose;
- FDA regulations;
- ICH Q3D guideline requirements; and
- Analytical challenges associated with E&L.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Wayland Rushing, Director of Scientific Affairs, EAG Labs
Recorded on: April 11, 2018
Description: Product development expert Anthony Parise explores the concept of risk-based thinking, what it means for the medical device industry and how to use it to improve operations. He discusses:
- How to better understand operational risk and risk management;
- How risk management processes drive new ways of looking at compliance in operations;
- The relationship between ISO 13485:2016 and risk management; and
- How to leverage common tools for regulatory compliance and product performance/safety.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Anthony Parise, Product Manager-Life Sciences, EtQ
Recorded on: April 10, 2018
Description: Attorney Katlin Backfield outlines recent regulatory developments regarding REMS and discusses possible outcomes. She covers:
- Commissioner Gottlieb’s emphasis on drug pricing and how it will affect the development of single shared-system REMS;
- Bills in the congressional pipeline and their odds on passage; and
- Recent trends in FDA’s REMS-related enforcement.
Presentation: Download the presentation
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Speaker: Katlin Backfield, Attorney and Consultant, Backfield PLLC
Recorded on: March 29, 2018
Description: Product management experts Daniel Matlis and Mike Jovanis discuss change management best practices and how to leverage technology for an effective and efficient change control process, including:
- Roles and responsibilities;
- A framework to systematically assess global operational and regulatory impact;
- Structuring and implementing change releases in a global environment;
- Streamlining processes between departments; and
- Gaining better intelligence to improve decisionmaking.
Presentation: Download the presentation
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Speakers: Daniel R. Matlis, Founder and President, Axendia, and Mike Jovanis, Vice President-Vault Quality, Veeva Systems
Recorded on: March 27, 2018
Description: Clinical trial management expert Wes Martz discusses ways to maximize your site feasibility and selection process. He covers:
- How to pre-identify most likely high-performing sites based on available historical performance data;
- Advice for tightening up feasibility questionnaires to reduce site burden;
- Examples of common “don’ts” in questionnaire development; and
- Insights into response data review and how to handle discrepancies.
Presentation: Download the presentation
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Speaker: Wes Martz, Associate Director, Clinical Services, ePharmaSolutions
Recorded on: March 20, 2018
Description: Pharmacovigilance expert Angela Pitwood explains how to use analytical data techniques in pharmacovigilance. She discusses:
- What Big Data is and isn’t, and how you can use it to improve your pharmacovigilance program;
- How the use of natural language can expedite the accurate reporting of adverse events;
- How you can train machines to report whether drugs were a determining factor in an adverse event; and
- What the future might bring in terms of new techniques for inputting and analyzing safety data.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Angela Pitwood, Vice President of Pharmacovigilance, Vigilare
