FDA Enforcement

FDA Enforcement Archived Events

Risk-Based Approaches for Validating Enterprise SharePoint Deployment in FDA-Regulated Environments

Speaker: Daniel O’Connor, Innovocommerce LLC

Date: Jan. 18, 2011

Description: This Webinar by Daniel O’Connor, Co-Founder, InnovoCommerce LLC, will introduce innovative best practice risk-based approaches to validating enterprise Microsoft SharePoint deployments in FDA regulated environments. The presentation begins with a high level introduction to SharePoint enterprise planning and deployment considerations for life science organizations that will consider use of validated applications. Thereafter the presentation helps the attendee understand strategic validation choices for the enterprise SharePoint farm(s).

The presenters then include an overview of GAMP 5 risk-based approaches to validating the enterprise SharePoint deployment–key strategic and tactical considerations are introduced. The presenters then introduce the risk-based matrix approach to understanding, identifying and attributing risk factors for enterprise SharePoint validation execution and ongoing control.

After providing a summary of the mission-critical risk matrix, the presenters provide sample views of how to understand, identify and review risk in a SharePoint enterprise environment.

Thereafter real case scenarios are introduced and addressed that demonstrate the mission-critical importance of leveraging risk-based approaches to managing SharePoint enterprise environments— whether they are validate or not. Finally the presenters introduce an overview of SharePoint enterprise validation execution tool kit including the documents and plan templates that any life science organization should consider to ensure that their enterprise SharePoint deployments are correctly qualified and managed to ensure compliance.

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How to Avoid Trouble with FDA in Your Sales Promotions

Speaker: Alan Minsk

Date: Jan. 6, 2011

Description: In an evolving financial and regulatory environment, pharmaceutical product promotion is becoming trickier than ever. Fore example, FDA is issuing more and more warning letters for Website marketing violations – 4 in September 2010 alone. How to stay ahead of the competition without landing in FDA’s crosshairs? This new presentation by Alan Minsk, Partner and Chair of the Food & Drug Practice Team of Arnall Golden Gregory LLP, will describe the key regulatory changes that have occurred regarding product promotion.

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Technology Transfer of the Manufacturing Process for a Water Sensitive Aseptic Drug Product to a Contract Manufacturing Organization

Speaker: Steven R. Villaseñor, Ph.D.

Date: Oct. 6, 2010

Description: This webinar presentation will describe the successful resolution of the challenges encounter in the technology transfer of a manufacturing process for a water sensitive aseptic drug product to a contract manufacturing organization (CMO).

What You Will Learn:
• You will gain insights in to proactively anticipating complications as well as managing unexpected challenges encountered for manufacturing technology transfers.
• You will think through quality risks of the drug product and successful mitigations.
• You will have a “real world” strategy for successful CRO interactions and how to avoid misunderstandings (the blame game) based on strengths, weaknesses and business drivers.
• You will see how a rapid resolution to a quality investigation was managed including a permanent resolution to eliminate the source of the problem while maintaining the timeline.

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How to Write FDA-Compliant Quality Agreements

Speaker: Alan Minsk, Partner and Chair, Food and Drug Practice Team, Arnall Golden Gregory LLP

Date: Sept. 16, 2010

Description: In an encore presentation of our top-selling Webinar of all time, Alan explains the do’s and don’ts of writing quality agreements, with a focus on both drugs and medical devices.

What You Will Learn:

  • Why it is critical to have a quality agreement — FDA may ask during an audit to review docs that describe how you manage contract service providers
  • Potential table of contents for a quality agreement
  • Why you must use FDA defined terms where they exist – FDA’s terminology must be considered sacred
  • Obligations for all stakeholders under a quality agreement — applicantion holder has ultimate responsibility for GMP compliance
  • How to develop a quality agreement — quality departments of sponsor AND vendor must be involved, flexibility is key, how to work with vendor’s QA
  • Relationship between the supply and quality agreement
  • The relationship between a commercial and quality agreement — can be one document but quality section should be extractable
  • How to work with vendors to develop a quality agreement — conducting due diligence is critical
  • Why you need to have a contract with your suppliers on quality

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Speaker: eCTD expert Antoinette Azevedo, President e-Submissionssolutions.com

Date: Sept. 15, 2010

Description: Ms. Azevedo will explain in detail all of the do’s and don’ts of electronic datasets, including:

  • What are the requirements for electronic datasets in eCTD submissions?
  • Where are the contents of clinical datasets located in the eCTD structure for: tabulation datasets, analysis-ready datasets and programs, and patient profiles?
  • What approaches should be taken to assure submission-readiness of datasets?
  • How can the datasets package be remediated for submission if the deliverables are not submission-ready?
  • What is the impact of CDISC and what steps should be taken now to assure compliance with CDISC requirements?
  • What steps should be taken if electronic datasets are not available?

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How to Prepare for FDA Advisory Committee Documents

Speaker: Uma Sharma, Ph.D., Chief Scientific Officer, MMS Holdings,

Date: July 20, 2010

Description: This presentation by Uma Sharma, Ph.D., Chief Scientific Officer, MMS Holdings, will detail how and how not to prepare briefing documents for FDA advisory committee meetings, which are becoming more and more frequent with premarket drug safety being such a concern today.

Details: Purpose of the Briefing Document; FDA’s process for briefing documents; Content Considerations; Key issues during review; Class issues; Unique safety issues; Novel indication/First in Class; Summary of benefit/risk; Briefing document vs slides; Briefing Document Do’s and Don’ts –

  • What is the appropriate level of detail to include?
  • Redacted versus fully disclosable data
  • Clear, concise presentation of data – tabular vs. summary
  • NDA/BLA requirements vs. briefing document
  • Consider the audience – data may need to be re-programmed, re-tabulated etc
  • Quality Control
  • Internal review process and key stakeholder input

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FDA’s Increased Use of Consent Decrees and Strict Liability Criminal Prosecutions

Speaker: Sheldon Bradshaw, former FDA Chief Counsel, Washington, D.C.

Date: June 16, 2010

Description: With FDA Commissioner’s recent vow to more aggressively enforce the Food, Drug & Cosmetic Act (FD&C Act), several recent consent decrees likely represent only the tip of the enforcement iceberg. Lurking under the water is the FDA Commissioner’s recent statement that she intends to increase the number of criminal prosecutions the Agency brings under the Park doctrine. Under the Supreme Court’s decision in United States v. Park, a corporate executive may be found guilty under the FD&C Act even though:

  • They did not intend to violate the law;
  • They did not actively participate in the violation; and/or
  • They did not act negligently.

Under the Park doctrine it is enough that an individual had the power and duty to prevent a violation and that they failed to do so. During their presentation Sheldon Bradshaw and Kyle Sampson will discuss the new FDA enforcement environment, focusing on the FDA’s increased use of consent decrees and criminal prosecutions.
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How to Use Cost-Effective Approaches to Manage Supplier Risk

Speaker: John Avellanet, Co-Principal, Cerulean Associates LLC
Date: March 3, 2010

Description: John Avellanet, author of Get to Market Now! Turn FDA Compliance into a Competitive Edge – speaking on how to deal with device and biopharmaceutical suppliers effectively.

Mr. Avellanet will show you how to improve your vendor management program to improve compliance, lower cost and minimize risk of FDA 483s:

— Effective, compliant strategy for selecting suppliers
— Tactics to share the compliance burden and regulatory risk
— A systematic methodology to ensure vendor accountability
— The challenges in vendor management
— Different categories of suppliers
— What the FDA will be looking for when it comes to vendor management
— Organizational considerations in implementing a vendor management system
— The benefits of pursuing a lean supplier strategy

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How to Implement Effective Risk Evaluation and Mitigation Strategies (REMS)

Speaker: Alan Minsk, Partner and Chair, Food and Drug Practice Team, Arnall Golden Gregory LLP

Date: March 4, 2010

Description: In this second REMS Expertbriefing by Alan Minsk, Partner and Chair, Food and Drug Practice Team, Arnall Golden Gregory LLP, you will learn the ins and outs of how to implement Risk Evaluation and Mitigation Strategies (REMS).

You also will learn details of FDA’s new draft guidance on REMS, issued Sept. 30, titled “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications.”

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Linking Good Science and Regulatory Expectations: Streamlining CMC Drug Development

Speaker: John Simmons, Ph.D., Retired from FDA

Date: Feb. 4, 2010

Description: Recent changes in the EU [Clinical Trial Directive] and recent FDA Initiatives have provided both challenges and opportunities for streamlining early drug development. The projected harmonization of the European community has resulted in a mechanism for a common CTA IMPD dossier but not without several significant new challenges to US firms wishing to conduct global trials. The FDA Initiatives are intended to provide a reduced regulatory burden on firms however most smaller firms and CMC contractors have yet to embrace them. This regulatory teleconference will be a one hour abbreviated highlights of a 2-day custom in-house course presented by Dr. John Simmons, recently of the ONDQA, CDER, FDA.

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FDA Chief Counsel Details How to Beat New “Aggressive” FDA Enforcement Policies

Speaker: Former FDA Chief Counsel Sheldon Bradshaw

Date: Dec. 3, 2009

Description: Returning for his fifth Expertbriefing, former FDA Chief Counsel Sheldon Bradshaw will detail new 2009 efforts by FDA and to enhance enforcement efforts more “aggressively.” He will also explain a NEW FDA policy stating you have just 15 days to respond to a 483 before FDA decides whether or not to send you a warning letter.

Also, discover how FDA will in the future set post-inspection deadlines, streamline the warning letter process, work more closely with its regulatory partners, prioritize follow-up on warning letters and other enforcement actions, be prepared to take immediate action in response to public health risks, and develop and implement a formal warning letter “close-out” process.

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6 Keys for Total eCTD Success

Speaker: Antoinette Azevedo, President, e-Submissionssoulutions.com
Date: Dec. 1, 2009

Description: This presentation will provide an overview of best practices to enable a sponsor to prepare a compliant eCTD for regulatory authority review. Learn top issues regulatory authorities have with eCTD and how to avoid them, prepare submission-ready source documents and datasets for submission in eCTD, whether to purchase an eCTD publishing system or to outsource, the role of an electronic document management system (EDMS) in an eCTD publishing solution, how to prepare for the technical challenges of eCTD, and how to interact with regulatory authorities to assure your eCTD submission is accepted for review.

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Former FDA Chief Counsel Advises Pharma on Critical Warning Letter Policy Changes

Speaker: Sheldon Bradshaw, Hunton & Williams LLP, partner and co-chair of the firm’s Food and Drug Practice Group
Date: Nov. 10, 2010 – Webinar Recording – Power Point Slides Included! Download or CD!

Description: Are you ready for FDA’s new, stricter warning letter policies? Former FDA Chief Counsel Sheldon Bradshaw teaches you the following: What is the new time frame in which companies must respond to a 483 before getting a warning letter? How to respond to warning letters and untitled letters? Will FDA send you a warning letter before taking action? What are the criteria for FDA taking enforcement action WITHOUT sending a letter first? How to avoid and recover from a warning letter? What proactive plans should be in place to avoid warning letters? How quickly can the Office of Chief Counsel take you to court after a warning letter is issued?

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