ComplianceOnline

Compliance with GCP is essential to obtain approval of an NDA or BLA from the Food and Drug Administration (FDA). Parallel rules that are very similar exist for most world wide regulatory venues also. Persons responsible for clinical trial management at the site or sponsor level must have a foundational understanding of GCP, even if many activities are outsourced to a Contract Research Organization (CRO), since regulators expect sponsors to maintain oversight over CRO operations. Site level personnel who manage clinical trials must be familiar with the portion of the regulations that apply to their operations, and it is helpful for these personnel to understand the broader picture, including the sponsor responsibilities.

This program will emphasize FDA's GCP requirements for human use pharmaceutical and biologic drug products. A brief overview of the requirements for medical devices will be included, as well as an overview of related requirements for Institutional Review Boards and for disclosure of potential financial conflicts of interest by clinical investigators.

The key ICH Guideline (E6) relied upon by most ex-US regulatory agencies will also be discussed, but the emphasis will be on US requirements.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

Upon completing this course participants should:

  • Understand the legal basis and basic provisions of GCP
  • Know the difference between requirements for sponsors and CROs vs sites
  • Understand the FDA inspection and enforcement process and become familiar with key resources to aid in inspection preparation
  • Understand enforcement options available to FDA to deal with violations

Who will Benefit:

This course is designed for people tasked with developing, maintaining and/or improving company policies and procedures for maintaining a state of compliance with US GCP regulations, including, but not limited to:

  • Clinical Quality Assurance professionals
  • Clinical Operations professionals
  • Clinical Research Associates
  • Regulatory Affairs personnel
  • GMP professionals who have GCP quality management responsibilities but less formal training in GCP principles, who wish to expand their knowledge base
  • Others at the sponsor, CRO and site level who want to enhance their knowledge of GCP
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Lecture 1: Introduction of Instructor and Participants: List participants' objectives for attendance
  • Lecture 2: Definition and scope of Good Clinical Practice
    • Legal basis in the Food, Drug and Cosmetic Act
    • Listing of regulations that together comprise GCP: 21 CFR 50, 312 (drugs) and 812 (devices)
    • Explanation of the relevance of closely related regulations: 21 CFR Parts 11, 54, 56 and the Department of HHS "Common Rule" for non-FDA regulated, Federal government funded clinical trials (45 CFR 46)
    • Role of ICH Guideline E6 for FDA regulated trials and its importance internationally
    • Placebo controlled trials; open label trials; comparator trials; ethical concerns surrounding placebo and comparator studies; criticality of maintaining blind
  • Lecture 3: Growth of the Contract Research Organization (CRO) industry and its importance today
  • Lecture 4: Informed consent: The concept and the governing regulations
  • Lecture 5: Responsibilities of Sponsors of FDA regulated clinical trials
    • Responsibilities as described in 21 CFR 312
    • Transfer of Regulatory Obligations (TORO) to CROs
    • Working with and maintaining oversight of CRO partner organizations - Sponsor responsibility and regulators' expectations of sponsors
    • Role of the Clinical QA Unit (and how it differs from the GMP Quality Unit)
  • Lecture 6: Site selection and qualification
  • Lecture 7: Investigator meetings and the Investigator's Brochure
  • Lecture 8: Site initiation procedures
  • Lecture 9: The Monitoring process
    • Monitoring plan
    • CRA role
    • Co-monitoring
    • Review of trip reports
    • Escalation process to deal with chronic noncompliance
    • Terminating a site for cause and reporting to FDA and/or other authorities
  • Lecture 10: Last half hour of the day: Check accomplishment of participant's identified objectives; general Q&A
Day 02(8:30 AM - 3:15 PM)
  • Lecture 1: The Trial Master File - content and maintenance
  • Lecture 2: Protocol deviations
  • Lecture 3: Review of safety reporting requirements (adverse events, serious adverse events, relatedness and expectedness considerations)
  • Lecture 4: Investigational product distribution and inventory reconciliation
  • Lecture 5: Responsibilities of clinical investigators
    • Role of the Principal Investigator ("PI")
    • Co-investigators
    • Clinical Research Coordinators at site level
    • CRFs, ECRFs and the query process to resolve inconsistencies
    • Interaction with the sponsor/CRO Medical Monitor
  • Lecture 6: Data Integrity and scientific fraud/misconduct issues
  • Lecture 7: FDA Inspections of Sponsors and Clinical Investigators
    • Overview of the process and key resources available from the FDA web site for inspection preparation
    • Timing of inspections - preannouncement in most cases
    • Triggers for inspections
    • Role of the Sponsor during CRO and Site level FDA inspections
    • Enforcement options FDA has and process followed
      • The FDA-483, its importance and how to respond
      • Case studies - Sponsor Warning Letter, CRO Warning Letter, Site Warning Letter
      • "NOOH" and "NIDPOE" letters
      • Disqualification of clinical investigators and the disqualification list
      • Other enforcement options
  • Final Wrap-up
    • Go over list of objectives from day one, ensure all objectives were met
    • Open discussion and Q&A
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
David L Chesney

David L Chesney
Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director)

David L. Chesney is the Principal and General Manager of DL Chesney Consulting, LLC.

His career includes 23 years with the FDA and over 21 years in GMP and GCP consulting worldwide. In his consulting practice, Mr. Chesney helps clients prevent quality and compliance problems through proactive assessment and planning, and when necessary, with remediation planning and health regulatory authority communications.

Until recently, he served as Vice President, Strategic Compliance Services for PAREXEL Consulting, a business unit of PAREXEL International LLC. Prior to joining PAREXEL Consulting in 1995, Mr. Chesney served 23 years with the FDA, where he advanced from Investigator to Supervisory Investigator and Director, Investigations Branch, working in the Boston, Seattle and Philadelphia District Offices. In 1991, he was appointed the District Director, FDA San Francisco District Office, where he served until joining PAREXEL in 1995. For 19 years, he led the Strategic Compliance Consulting group, and also personally provided regulatory enforcement related consulting services to the pharmaceutical, medical device and biologics industries, plus technical assistance to legal counsel in FDA regulatory matters. Mr. Chesney has a bachelor's degree and postgraduate credits in biology from California State University, Northridge and San Diego, and received a Certificate in Health Care Compliance from Seton Hall University School of Law.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$1,299.00

Seminar One Registration

November 8-9, 2017, San Francisco, CA
(For Registrations till August 30, 2017 - $1299)
(For Registrations till September 15, 2017 - $1499)
(For Registrations till October 20, 2017 - $1599)
(For Registrations after October 20, 2017 - $1699)

$5,999.00
$7,794.00 (23%)*

Save $1,795.00

Special Group Discount Register for Six attendees

November 8-9, 2017, San Francisco, CA
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left




Early bird seats are limited and based on first-come, first-serve.

Your registration fee includes the workshop, all course materials and lunch.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 260
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Location

San Francisco, CA
(Venue to be announced shortly)

November 8-9, 2017

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

Benefits of becoming a Sponsor/Exhibitor/Media Partner:

  • Logo on website, marketing email, branding materials & the registration booth
  • Exhibit Space
  • Free event pass
  • Speaking opportunity
  • Social media campaign

For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

Media Partner:

Media Partner

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Local Attractions of San Francisco, CA

Think Escape Party Bus

Think Escape Party Bus
San Francisco Bay Area

Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport. Think Escape's Bay Area party bus rentals include free entry into selected exclusive nightclubs, professional hostess and chauffer, in-vehicle coolers stocked with amenities for a perfect night of partying.

Alcatraz Lunch Cruise

Alcatraz Lunch Cruise

The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.

Luxury Catamaran Sailing Cruise

Luxury Catamaran Sailing Cruise

A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.

City Kayak

City Kayak

City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.

Think Escape Casino

Think Escape Casino Tour
San Francisco Bay Area

San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

We need below information to serve you better

Best Sellers
You Recently Viewed
    Loading