ComplianceOnline

Today, many companies operate on an outsourcing model. This is very common for companies who are evolving from being mainly development-focused to a point where they are entering latter stages of Phase 2 or Phase 3 clinical trials, and plan to have a product ready for market approval in the coming months. Most such companies are small, and may not have deep expertise in QA and GMP compliance, relying on their partners to cover those areas. Companies who outsource the majority of operations through the use of Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs) and Contract Laboratories, however, remain responsible for the quality and compliance status of the products they send to the clinic or to the marketplace.

In this two day workshop conference you will learn the requirements and expectations of major health care regulators that are applicable to "virtual" companies. You will learn how to diagnose your company's needs based on which GMP and GCP-governed operations you retain and which you outsource; what the current expectations and best industry practices are for selecting, qualifying and monitoring your contractors to ensure they are meeting your requirements; and how to build a quality system framework that is not excessive for your current needs, but has the structure and integration to "grow with you" as the scope your operations change in the coming months and years.

You will also learn best practices for managing a regulatory inspection, with emphasis on FDA, EMA and Health Canada, but applicable to most other major agencies as well.I

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:

Participants in this seminar will:

  • Understand the GMP and GCP requirements all virtual companies must meet regardless of the extent of their outsourcing operations
  • Understand how to select, qualify and monitor CMOs, CROs and Contract Laboratories
  • Learn the elements to include in a quality agreement (also known as a technical agreement)
  • Learn how to determine which GMP or GCP requirements apply to you, depending on the things you do internally and those you outsource
  • Understand your obligations under the law for products you release to the clinic or the marketplace
  • Appreciate the importance of maintaining data integrity
  • Learn how to effectively manage a health regulatory inspection:
    • Inspection logistics
    • Responding effectively to document requests and questions from inspectors
    • Managing the inspection exit discussion
    • How to write an effective response to inspection observations
    • How to find applicable inspection references and procedures of the FDA, EMA and Health Canada

Who will Benefit:

This course is designed for those charged with managing Quality Assurance and Regulatory Affairs for companies in the development or commercial phase of growth who either release investigational drugs to clinical trial sites or send commercial products to the market, but rely to a great extent on the use of Contract Manufacturers and/or Contract Laboratories. The following personnel will benefit from the course:

  • Senior quality managers in manufacturing QA/GMP or clinical quality areas
  • Quality professionals
  • Regulatory professionals
  • Clinical Operations
  • Compliance professionals
  • Quality auditors – GMP and GCP
  • Document control specialists
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Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Introductions and participant expectations for the program
  • Fundamentals of Good Manufacturing Practice
    • What is GMP?
    • Purpose of GMP
    • Basis in law: US, Europe, Canada
    • Elements that apply to all virtual companies
    • Elements that depend on how operations are conducted: How to tell what applies to your company
  • Data Integrity: What it is and why it is important to GMP
  • Fundamentals of Good Clinical Practice (GCP)
    • What is GCP?
    • Purpose of GCP
    • Basis in law: US, Europe, Canada
    • Elements that apply to all virtual companies
    • Elements that depend on how operations are conducted: How to tell what applies to your company
  • Regulatory and business risks: The case for compliance
  • Virtual company organizational structure and responsibility for QA/GMP/GCP
  • Virtual company quality system structure and management
    • Policies, procedures, documentation management
    • Metrics and management review considerations
  • Selection, qualification and monitoring of contractors
    • Initial due diligence – public information sources to gage compliance
    • Qualification of vendors
    • Quality agreements – determining and documenting responsibilities for GMP
    • Vendor audit program
  • Day One Q&A and recap of progress meeting stated course expectations
Day 02(8:30 AM - 4:30 PM)
  • Regulatory Inspections
    • Purpose of an inspection
    • Reasons for inspections
    • Inspections at virtual company headquarters locations – purpose and scope
    • Inspections at CMOs and Contract Labs
    • GMP inspections versus Preapproval inspections – FDA
    • GCP inspections of sponsors of clinical trials
    • EMA inspections – contrast with FDA
    • Health Canada inspections
  • Logistics for managing inspections at your location
    • Information sources about inspections on agency web sites: What you need and how to find it easily
    • Preparation for inspections
    • Overall process – ready room support
    • Receiving and hosting the inspectors
    • Providing documents
    • Answering questions
    • Interpersonal dos and don’ts for interacting with inspectors
    • Managing the exit discussion at the conclusion of the inspection
  • Inspections at your contract organizations
    • Making sure your CMO and contract lab are “PAI ready”
    • Training employees to assure inspection readiness – pitfalls to make sure you avoid
    • Conducting mock inspections effectively
  • Post-inspection communications with the inspecting agency
    • How to write an effective response
    • Common mistakes to avoid
    • Following up to ensure the response is satisfactory
    • When to request a meeting, and if granted, how best to handle it
  • Enforcement considerations
    • FDA enforcement process – domestic and ex-US
    • EMA enforcement
    • Health Canada
  • Final Q&A, discussion, and conclusion
  • 4:30 PM: Adjourn
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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.

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$1,499.00

Seminar One Registration

March 16-17, 2017, San Diego, CA
(For Registrations till January 10, 2017 - $1499)
(For Registrations till February 10, 2017 - $1599)
(For Registrations till March 1, 2017 - $1699)
(For Registrations after March 1, 2017 - $1899)

$2,299.00

Seminar One Registration (With 2 Nights Stay)

March 16-17, 2017, San Diego, CA

$6,799.00
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March 16-17, 2017, San Diego, CA
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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 Diego, CA
(Venue to be announced shortly)

March 16-17, 2017

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If you wish to partner with us for this event please contact us: partner@complianceonline.com or call us: +1-888-717-2436.

Sponsors
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Gold Partner
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  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website
Silver Partner
  • Logo on name cards
  • Logo placement on the podium
  • Logo on the lanyards for all speakers
  • Exclusive stall at the entrance
  • A full page brochure advert
  • Moving banner ad on the website
Bronze Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website

If you wish to sponsor this event please contact Cruise Webster: cwebster@complianceonline.com or call us: (207) 576-4173

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Local Attractions of San Diego, CA

San Diego Cabrillo National Monument

San Diego Cabrillo National Monument

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. 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. 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.

Sea Creatures at Birch Aquarium

Sea Creatures at Birch Aquarium

Birch Aquarium is north of San Diego in La Jolla. It's not as big as some of the other aquariums in California or as flashy as the big sea-themed park down the road, but instead just right, filled with interesting exhibits and home to leafy sea dragons like the one above, creatures so improbably they look more like something from a children's book than from the ocean.

Legoland

Legoland

Legoland theme park takes its inspiration from Lego toys, those cute little bricks that snap together to build all kinds of fun things. It's one of several Legolands worldwide.

San Diego Zoo Safari Park

San Diego Zoo Safari Park

The San Diego Zoo's sister park offers a different kind of animal experience. Its name (Safari Park) is the clue and it indeed offers a more safari-like experience. Lots of large animals live in the same big, open areas here - predators kept away from prey, but otherwise much as they would in their natural habitat.

Coronado Island

Coronado Island

Coronado isn't really an island but a peninsula - a fact that doesn't get in the way of the name most people use for it. Whatever you call it, it's on a slender strip of land between the San Diego Bay and the Pacific Ocean, barely a few blocks wide. What it lacks in size it makes up for in fun, with a beach that's been named among the best in the country, a classic hotel and a compact, lively little downtown. Coronado's laid-back temperament makes a nice break from the busier parts of San Diego across the water.

Balboa Park

Balboa Park

Originally built for temporary use during the 1915-16 Panama-California Exposition in San Diego, Balboa Park boasts buildings beautiful enough to be considered attractions in themselves, especially if you're a photographer. They're surrounded by trees, lawns and fountains, but that's only the beginning.

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