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!


May 22, 2018

A WCG/CenterWatch Webinar

Managing Safety Reporting for Advanced Therapies

1:30 PM - 2:30 PM Eastern

Advanced Therapy Medicinal Products (ATMPs) are at the cutting edge. The profit potential is enormous, as is the potential benefit for patients with now-untreatable or incurable conditions.

But as anyone who’s been there knows, the cutting edge can be a cold and dicey place.

  • How will patients react to gene therapy and other novel treatments?
  • What challenges are associated with developing, monitoring and reporting safety profiles and determining the benefits vs. risks?
  • Most pressing of all, how do you adapt your safety reporting under systems that were designed decades ago for traditional drugs?

Angela Pitwood, VP-Pharmacovigilance at Vigilare International, a WIRB Copernicus Group (WCG) subsidiary, has spent years working with all types of products both in clinical development and post approval. She can share with you the best ways to meet compliance for products used in personalized medicine.

This FREE webinar features an hour with Ms. Pitwood:

  • Discussing cutting-edge therapies that offer hope for conditions for which there are limited or no therapeutic options now …
  • Looking at how they work and how they’re developed …
  • FDA safety reporting now: What the agency can do, what it does do …
  • FDA safety reporting to come: New mechanisms the agency may apply to such therapies …
  • And much more!

ATMPs promise a bounty of new profits for drug and biotech makers … and a host of headaches on the road to that goal. This FREE sponsored webinar offers an edge in a competitive new area. Sign up now for this FREE presentation.


May 30, 2018

A WCG/CenterWatch Free Webinar

Cutting the Costs of Clinical Trial Subject Recruitment. Insights into Patient Outreach: Traditional vs. Digital

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

Clinical trials cost many millions of dollars. They don’t have to. Cost savings — big ones — exist. You just need to know where to look for them.

That’s the message from Steven Pyffer, Senior Director of Patient Outreach of ThreeWire LLC and an authority on trial subject recruitment.

Some 13 years ago, he left the ad-agency world to focus on the clinical-trial sphere, introducing modern media techniques to an area that had relied on dipping repeatedly into a subject pool that grows slowly if at all.

Mark your calendar for Wednesday, May 30, and a fast-paced hour with Mr. Pyffer discovering outreach techniques to bring your drugs and devices to market faster … and cheaper. This session is sponsored by WCG/Centerwatch, the leading provider of clinical trial industry news and information, in cooperation with FDAnews. It’s FREE — and packed with need-to-know information including …

  • Hidden costs: How factors such as site selection boost clinical-trial costs almost invisibly
  • Trial phases variations: How costs of Phase I trials differ from those of Phase II, II from III, III from IV
  • Marketing secrets: Did you know that offering subjects $500 sometimes doubles response rates?
  • Old media vs. new: Why it can be more cost-effective to spend tens of thousands on TV than supposedly “free” social media
  • Mixing things up: Reasons to use a variety of media rather than focus on one or two
  • Keeping it real: The risks of recruitment ads that resemble those Rx commercials on network TV
  • And much more!


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