May 8-9, 2018

Building a World-Class Advertising and Promotion Review Program
Philadelphia, PA

Come to Philadelphia in May for two days of intense learning. You'll arrive back home with a bag full of tricks and tips to keep all your marketing efforts squeaky-clean.

Understanding Pre-Approval Communications: Don't get on the FDA's or SEC's radar screens before your product is even approved. Learn how to properly disclose information and remain in compliance. How to Maximize Disease Awareness Communications: Take away valuable tips and tricks for using disease awareness communications pre- and post-approval.

Hurray! You're Approved: Build the most aggressive — but compliant — campaign from first day of approval to commercial launch.

Assuring Your Promotions Meet FDA Off-Label Standards: Successfully navigate 4 major traps that can earn you a warning letter fast.

Itching to do More with Social Media?: Discover how to get your message out there ... without crossing the line.

Understanding Off-Label Communications: How will the November 2016 FDA memo and January 2017 FDA guidance affect your communications?

Your workshop leader is Dale Cooke, principal of PhillyCooke Consulting. Mr. Cooke's practice specializes in helping FDA-regulated companies develop compliant promotional tactics and improve the promotional review. He is the author of Effective Review & Approval of Digital Promotional Tactics and is currently at work on a book about compliant social media usage for prescription product manufacturers.

For details and registration, Click Here

May 10, 2018

West Coast Symposium on Expanded Access
San Francisco, CA

Mark your calendar for Thursday, May 10, when FDAnews presents the first-ever West Coast Symposium on Expanded Access, an all-day event for the drug, device, diagnostics and clinical trial communities.

An all-star cast of presenters will probe Expanded Access from every angle — regulatory, scientific, business, patient safety and liability. You’ll go home ready to take full advantage of new laws and rules ranging from the 21st Century Cures Act to right-to-try state and federal legislation.

Here’s just a sampling of what you’ll hear about:
  • Government Actions: President Trump showed his support for “right to try” legislation in his State of the Union message. Discover how this may affect Expanded Access.
  • What’s Happening Now: Case studies of work under way in real time at drug, device and diagnostics firms. Real World Evidence/Real World Data: RWE and RWD are transforming data collection at FDA-regulated companies, nowhere more than in Expanded Access data collection and its application to clinical processes.
  • Best Practices: Better management of planning and operational concerns posed by Expanded Access programs, including implementing best practices.
  • Debunking Myths: Pre-approval access is not well understood. Here’s where you get the real story.
  • Getting Your Feet Wet: How to implement well-designed Expanded Access programs in your organization; understanding particular label and peripheral indications to identify covariates of treatment response and generate valuable RWE.
  • And MUCH More!

For details and registration, Click Here

June 5-6, 2018

FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers
Philadelphia, PA

Managing your business' essential data in compliance with FDA’s regulations can be an overwhelming undertaking. If you don’t start planning for how to control data integrity as part of trial planning, you can NOT add it in later.

That’s why FDAnews has teamed up with John Avellanet and Cerulean Associates to develop an interactive workshop for you — Data Integrity for Device and Pharma Firms and Their Suppliers. After two days of 'total immersion' study, you'll return to your office with increased understanding based on team exercises and case studies … informative, detailed explanations … and honest no-holds-barred discussions with John and your fellow attendees.

  • Data Integrity and What’s Really Required
  • Suppliers and Data Integrity: Who’s Actually Accountable?
  • Practical Realities: The Business Costs of Poor Data Integrity
  • Critical Data Integrity Elements to Prove Compliance
  • Modern Validation Protocol
  • Mapping Your Data Chain-of-Custody
  • Advanced Tactics to Cut Costs and Reduce Your Workload
  • Data Integrity, Recordkeeping and Archival Controls
  • Building Your Business Case for Defensible Data Integrity

For details and registration, Click Here

June 7-8, 2018

SOPs and Policies for the 21st Century
Philadelphia, PA

While a good SOP helps you demonstrate your compliance and say to inspectors and auditors alike: “We know what we are doing — and why,” the modern SOP enables your business and your compliance success.

In today's busy, stress-filled workplace, your staff needs (and hopes for) SOPs that are easy-to-follow, quick reads. Even regulatory investigators support that idea, saying: “It’s better to have an easy-to-read process map that you can actually follow than to have a detailed SOP that you don’t.”

Yet, in 2017, "inadequate SOPs" was once again a Top 5 most-frequently-cited FDA non-compliance observation.

Attend this highly-interactive, two-day workshop that will teach you down-to-earth, practical techniques you need for writing fast, flexible and compliant SOPs — SOPs that will meet regulatory requirements and today’s globalized expectations.

This two-day workshop will be led by John Avellanet, an award-winning FDA compliance expert known for his business-savvy, pragmatic advice and engaging speaking style.

A former FDA and US DOJ prosecutor has said of John Avellanet, “He is the best in the business. Period.”

What You Will Learn

Not only does this workshop provide you an opportunity to hear from an acknowledged expert in SOPs, but you'll also share experiences and learn from your fellow attendees who are confronting the same issues as you. Attend this critical workshop and you'll find out:

  • What FDA investigator questions to expect about your SOPs and policies
  • How to use forms, checklists, and templates to reinforce compliance
  • Why FDA, your staff and your management like to see process maps
  • Simple metrics that work for SOPs and policies
  • What mistakes to avoid in your “SOP of SOPs”
  • How to write an SOP to oversee an activity you’ve outsourced.

For details and registration, Click Here

June 13-14, 2018

Ensuring The Quality Connection with your CMO
Philadelphia, PA

CMOs give you a manufacturing edge. That’s why you take them on. But then too often you find yourself in a management morass — getting unsatisfactory results, wasting precious time and resources, even skirting with regulatory violations.

Maybe it’s time for a fresh approach — a quality systems-based relationship rather than the piecemeal management style that drags down so much of drug, device and diagnostics manufacturing.

Mark your calendar for the workshop where you discover all that — and more.

You’ll spend two days in intense hands-on learning with ValSource COO Hal Baseman and his team of experienced instructors (who have worked on both sides of the contract giver and acceptor equation). They’re steeped in quality systems, aseptic processing, validation, training, contamination control and running a CMO. You’ll go home armored with your own plan to build and managed a risk-based lifecycle model custom-tailored to your needs. Here’s just a sampling of what you’ll discover:

  • What to include in quality agreements: ‘Must have’ vs. ‘nice to have’
  • Working with a CMO using a hazard identification tool (HIT)
  • Regulatory citations: Who is responsible — you, or the CMO?
  • Monitoring and auditing your CMOs
  • Team-building: Participation from the owners’ organizations and CMOs (plant-in-plant concepts)
  • Joint effective and efficient deviation investigation techniques
  • Creating a checklist: Key items to consider when working with a CMO
  • Avoiding and resolving conflicts between client company (“contract giver”) and CMO (“contract acceptor”)
  • Communication information to comply with process validation and health authority expectations
  • And much more!

For details and registration, Click Here

June 19-20, 2018

Medical Device Risk Management
Raleigh, NC

Effective medical device risk management follows a well-defined process.

The process in ISO 14971:2007 and EN ISO 14971:2012 is simple and straightforward. While the process has clearly defined steps in a natural flow, many companies don’t follow it, and, as a result, create numerous problems. In the worst case, the incorrect process results in inadequate protection, patient or user harm, adverse event reports, and lawsuits.

Medical device risk and its management are not abstract concepts. ISO 14971:2007 — the international process standard — provides a method to protect patient and user safety. The standard supports specialized risk management topics including usability, biocompatibility, cybersecurity, and electrical safety.

The Medical Device Directive, MDD, has requirements that differ from the international standard. The process remains the same, but some of the process steps change. EN ISO 14971:2012, a harmonized standard, enumerates the differences.

The Medical Device Regulation, EU-MDR, has additional requirements, likely to trigger a new European version of the standard.

This workshop, led by industry expert Dan O’Leary, provides the information you need to understand and implement an effective medical device risk management process. The first day focuses on the risk management process, providing both an overview and the details. It explains the differences among the international version, the EU-MDD version, and the anticipated EU-MDR version. The second day focuses on applications that require an effective risk management process. During the workshop, participants:

  • Learn the fundamental concepts of risk management
  • Understand the regulatory structure including the US, Canada, the EU current state, and the EU future state
  • Review recent FDA Warning Letters and understand how to avoid their problems
  • Learn the process flow in the international standard, ISO 14971:2007
  • Understand the details of the EU-MDD variant, EN ISO 14971:2012, and its implementation
  • Anticipate risk management changes from the EU-MDR and EU-IVDR
  • Review the relationship between an ISO 14971:2007 Risk Management System (RMS) and an ISO 13485:2016 Quality Management System (QMS)
  • Review the risk management audit tasks from the MDSAP Audit Model
  • Understand the role of risk management in post-market surveillance

Risk management affects nearly every aspect of medical device manufacture. Yet many devicemakers lag behind the curve, courting warning letters or worse. Get your operation up to speed quickly and easily.

For details and registration, Click Here

Training Programs

Phlebotomy Training in 2 days!

Learn to draw blood quickly. The program consists of one day online training at your own pace and one day hands-on training in the classroom setting. We come to your location. Train now!


April 23, 2018

A CenterWatch/FDAnews Webinar

Managing Cybersecurity Risks in the Medical Device and Healthcare Sectors

1:30 PM - 3:00 PM Eastern

“Smart” medical devices also have underlying cybersecurity and privacy risks. They are also top targets from a host of global attackers from nation states to sophisticated criminal gangs. The health sector — including medical device manufacturers as well as pharmaceutical and biotech companies — face uncharted regulatory and liability risks.

FDAnews has invited global cybersecurity expert Norma Krayem and FDA expert Michael Werner to walk you through the rapidly changing global regulatory landscape and show you new coping strategies.

Mark your calendar for Monday, April 23, when Ms. Krayem and Mr. Werner paints the picture over 90 fast-paced minutes. From Cybersecurity Executive Order 13800, to HIPAA, FDA activities, Homeland Security and more, you’ll explore:

  • Cybersecurity-triggered changes in interpretation of HIPAA, and enforcement by the HHS Office of Civil Rights, as they affect quality and regulatory matters
  • Cybersecurity as an enterprise risk management issue affecting security, risk and privacy functions in device firms
  • Homeland security: How DHS cybersecurity initiatives, including the Automated Information Sharing (AIS) program, can help you understand the threat from nation-states, non-state actors and other potential attackers
  • FDA’s evolving focus on cybersecurity and how it impacts the risk, responsibilities, and regulation of companies
  • The Cybersecurity Information Sharing Act (CISA) and the Protected
  • Critical Infrastructure Information (PCII) as potential “safe harbors”
  • New international privacy and cybersecurity laws impacting the health sector
  • And much more!

Do you know what the FDA, HHS, DHS and global regulators are planning? The cost of ignorance could include regulatory sanctions and liability judgments and cybersecurity attacks are only growing. Don’t risk your organization’s well-being in the scary new cyber era.


April 27, 2018

A WCG/CenterWatch Webinar

Clinical Trial Portals Essential for Small, Mid-Size Biotech Firms:- Are You Standing Out in an Increasingly Crowded Space?

1:30 p.m. - 2:30 p.m. ET

As a small or mid-size biotech firm, you know how important it is to partner with Big Pharma and attract investor capital from VCs. But do you know your clinical trials portal could be what differentiates you from the competition?

Are you prepared for this challenge? What does your clinical trials portal look like? Can you demonstrate to Big Pharma that you’re head and shoulders above the competition — that you’ve got a world-class clinical trials portal that runs like a well-oiled machine?

If you want to attract partners, your site needs to be exceptionally efficient, enabling deadlines to be met and, most importantly, ensuring that you receive those valuable contracts and payments from investors and Big Pharma.

Are you looking for ways to leverage investments to hit those milestones predictably? Would you like to know how to demonstrate conclusively that you’ve got the technology solutions that your partners are expecting to ensure that startup timelines are achieved?

In just 60 minutes, from the comfort of your own office, you’ll get an in-depth view of why it’s essential for your company to develop a world-class clinical trials portal. Save this date — April 27, 2018 — to hear one of the leading authorities on biotech clinical trials explain how to build or modify a portal that will enable you to run compliant and efficient trials and stay ahead of your competition in getting to market. Here’s what you’ll learn during this interactive session:

  • How clinical trial portals enable you to differentiate yourself from your competition with potential Big Pharma and VC partners
  • How to demonstrate you’ve got the technology solutions in place to efficiently meet milestones, deadlines and startup times for your clinical trials
  • How to attract the top sites to participate in your clinical studies
  • How to leverage investments to predictably hit milestones and deadlines

Take advantage of this free, timely presentation to learn the nuances of clinical trials portals.


May 1, 2018

An FDAnews FREE Webinar

How Digital Technology is Transforming... YOUR Quality Management

1:30 p.m. - 2:30 p.m. EDT

As an FDA-regulated drug or device maker, CRO or CDMO, your commitment to top quality in manufacturing goes without saying. You’re 100% up to date on the latest tools and techniques.

But lowering costs without disrupting product quality, safety, efficacy, compliance and continuity, presents a major hurdle that may seem impossible to overcome; a problem that is compounded by the rise of 3D printing, automation, cloud computing and personalized medicine within manufacturing.

Mark your calendar for an hour in the company of a leading quality consultant whose head, quite literally, is in the Cloud.

In this business-driven webinar sponsored by Sparta Systems, Steve McCarthy, Sparta’s VP for Digital Innovation, demonstrates how digital technology is transforming quality management in companies like yours. You’ll discover:

  • Benefits and challenges of using cloud platforms and other digital technology in a Quality and/or GXP-regulated environment
  • Consequences of an inferior quality management system
  • Foundations of a superior quality management system
  • How to use digital technology — including cloud platforms — to augment your quality strategy
  • Cost saving and value add opportunities to help your company thrive
  • And MUCH more!

Maintaining quality gets harder every day. Emerging technologies offer great promise but also steep learning curves. Your never-ending challenge is to get the greatest quality for the least outlay. Here’s help from someone can tell you how.

Who Will Benefit Drug and device makers, CROs and CDMOs all will benefit from this presentation, particularly executives with titles including:

  • Quality
  • Digital Innovation
  • Compliance
  • Procurement
  • IT

May 8, 2018

A CenterWatch/FDAnews Webinar

Top Tips for Dealing with the FDAHow to Engage, Respond to Inquiries and Avoid Enforcement Actions

1:30 p.m. - 3:00 p.m. EDT

The FDA is an inescapable presence in your life. It can be supportive and helpful one day, then turn on a dime and make life quite difficult indeed.

But you have a say in the matter. You can control this all-important relationship to your advantage.

Here’s how.

Mark your calendar for 90 minutes of Top Tips with one of Washington’s leading FDA lawyers, Will Woodlee Esq. of Kleinfeld Kaplan & Becker LLP. Regardless of which party makes the first move — you or the agency — this session will ready you with best practices, moves and countermoves:

  • How to respond to a Form 483
  • How to avoid a warning letter
  • How to ask sensitive questions: Implementation of particular laws or regulations
  • Alternatives to direct engagement
  • Safeguarding sensitive commercial information
  • What to do when your competitor isn’t complying with FDA requirements
  • Identifying the correct agency point of contact
  • Resources available to you
  • And much more!

The FDA is an institution, true. But it’s also an organization staffed with human beings with their own agendas, open or hidden. Managing them shouldn’t be all that different from managing staff. Why not learn better ways to do so ... now! Register now.

Who Will Benefit

  • Regulatory affairs/compliance
  • Quality/GMP
  • General/corporate counsel
  • Outside attorneys

June 14, 2018

A CenterWatch/FDAnews Webinar

Setting and Measuring Quality Objectives for Medical Devices

1:30 p.m. - 3:00 p.m. EDT

Device quality must be implemented and communicated to the FDA, on pain of warning letters or worse. The rules and procedures are technical, involving both FDA rules and ISO 13485:2016. But mastery can be accomplished in only 90 minutes. FDAnews has reached out to Dan O’Leary for guidance. Mr. O’Leary, one of our most popular presenters, will walk you through the process and give you compliance tools to make warning letters a thing of the past. You’ll discover:

  • QSR requirements for the Quality Policy and Quality Objectives
  • Methods the FDA investigator uses to verify compliance
  • Additional requirements from ISO 13485:2016
  • Sample Quality Policies illustrating the requirements
  • Methods to develop Quality Objectives from the Quality Policy
  • How to describe of the three types of metrics
  • Use of Excel to develop a graphical approach to the metrics
  • And much more!

Special Bonus Material: Participants receive a checklist to help ensure the system is prepared for your next FDA Inspection, Notified Body audit, or MDSAP audit.

Warning letters aren’t the only reason to sign up. Quality improvements lead to smoother manufacturing, greater patient safety, less liability risk and greater profits in the long term — a payoff well worth 90 minutes of your time. Register now.

Who Will Benefit This presentation focuses on Quality Policy, Quality Objectives, and associated metrics, subjects of particular interest to:

  • QA/QR/QC
  • Production managers
  • QMS process managers
  • Continuous improvement specialists
  • Quality engineers
  • Management representatives
  • Management review attendees
  • Consultants

June 21, 2018

A CenterWatch/FDAnews Webinar

The Real Impact of Common Rule in 2018: Understanding Nuances, Facilitating Compliance & Implementing Best Practices

1:30 p.m. - 3:00 p.m. EDT

The first revisions to the Common Rule in more than a decade have thrown the clinical trials industry into a seemingly perpetual spin cycle. This webinar will enable you to fully understand the key changes to the Common Rule and how they dramatically impact IRBs and virtually every entity engaged in clinical research. Save this date — March 27, 2018 — to hear one of the leading authorities on the Common Rule rule explain:

  • Changes to Informed Consent, which add new requirements for consent documents and new guidance for investigators in the consent process.
  • Changes to Broad Consent, which now allows, but does not require, researchers to request broad consent from subjects for secondary research involving identifiable private information and identifiable biospecimens.
  • Implementation of Limited IRB Review, which introduces this new concept in connection with exempt research, expedited review and the criteria for IRB approval of research.
  • Exemptions, including provisions that modify existing categories of exempt research, add new exemptions for certain low-risk studies and provide additional carve-outs for activities not classified as research.
  • Updates to SOPs, which result in institutions and IRBs having to update their standard operating procedures, including the definitions of “research” and “human subjects.”
  • And much more!

Make sure you continue to receive grant funding from federal agencies and departments that have adopted the Common Rule. And avoid allegations of noncompliance or incident reporting to the OHRP.

Your presenter, Carrie Hanger, Esq., an expert on clinical trial regulation and a partner in the law firm of Nelson Mullins Riley & Scarborough, will provide the information you need to obtain grants and avert noncompliance.

As you’ll hear from Ms. Hanger, the implementation date for compliance with the new regulations and guidance is set to kick in before you know it, but even that date is in flux (all the more reason to attend the webinar).

Do not get stuck in this legal quicksand. Take advantage of this timely presentation to learn the nuances of the revisions and the tips you can put into place to achieve complete compliance. Sign up now.

Meet Your Presenter

Carrie Hanger, Esq., is a partner at Nelson Mullins Riley & Scarborough specializing in the regulatory compliance of healthcare providers and clinical and preclinical decisionmakers and researchers in the U.S. With more than a decade of direct experience representing and counseling clients, Hanger provides solutions for issues relating to enrollment and reimbursement, licensure and certification, regulatory and corporate compliance, risk management and business disputes. She regularly analyzes issues related to clinical and preclinical research and drafts and negotiates clinical research-related documents, such as clinical trial agreements and confidentiality agreements. Carrie has spoken at numerous CLEs and seminars for healthcare providers concerning reimbursement and compliance issues related to clinical research.

Who Will Benefit This session is appropriate for organizations subject to the regulatory implementation of the Common Rule, including CPSC regulation, specifically individuals holding job titles including:

  • Regulatory and compliance specialist
  • IRB member or staffer
  • Principal investigator
  • Study coordinator
  • Clinical researcher or associate
  • Clinical recruiter
  • Risk manager
  • General or outside counsel
  • Institutional official
  • Medical affairs director