One and a Half day In-Person Seminar

Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

BY: Andrew Campbell,

Pharmaceutical Consultant - Quality & Compliance

November 14-15, 2019
Tampa Marriott Westshore, FL
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"This education activity has been submitted to the Compliance Certification Board (CCB)® and is currently pending their review for approval of CCB CEUs."

The globalization of the pharmaceutical supply chain has led increased us of Contract Manufacturing Organizations (CMOs). The use of CMOs provides many benefits; however, it can present unique compliance risks, particularly since the operations are not in your facility and therefore not under your direct control. The compliance risks are highlighted by FDA Warning Letter trends, the majority of which are related to serious compliance and data integrity issues at foreign CMO sites.

If you use CMOs, your company has the ultimate responsibility for product quality, safety, efficacy, and cGMP compliance. Furthermore, FDA has clearly stated that organizations using CMOs will be held accountable for CMO compliance to cGMPs, as well as adherence to regulatory commitments. Therefore, issues identified at your CMO may result in FDA 483s and/or Warning Letters issued to your company. Since FDA is holding firms using CMOs responsible, it is imperative that your organization have a robust CMO management system. At the end of the day, your organization’s ability to provide proper quality oversight of CMOs is the key to assuring product safety and your company’s compliance profile.

This seminar will help all personnel responsible for CMO oversight understand how to manage CMOs- from start to finish. In-depth focus will be placed on Selection and Qualification, Quality Agreements, Understanding of CMO Operations, and Review of Key CMO Records. Considerations for different types of manufacturing will be highlighted, and techniques for managing difficult CMO situations will be discussed. This is a practical how-to course, designed to provide participants with skills they can immediately apply to CMO oversight within their own organizations. Group exercises will allow participants to practice skill sets with feedback from the instructor.

Learning Objectives:

Upon completing this course, participants should be able to:

  • Understand the CMO business model
  • Learn the regulatory requirements for CMO quality oversight
  • Learn how to structure your organization for effective CMO oversight
  • Learn key points for selecting and qualifying CMOs
  • Learn how to prepare for and conduct CMO Qualification Audits
  • Learn how to develop a Quality Agreement and how to execute it
  • Learn how to understand CMO operations
  • Learn key points for reviewing CMO records
  • Learn how to resolve issues identified in CMO records
  • Learn how to prepare for and conduct routine CMO audits
  • Learn how to manage CMOs on an ongoing basis
Who will Benefit:

This course is designed for people tasked with oversight of these CMO functions:

  • Manufacturing operations
  • Quality Control operations
  • Quality Assurance operations

The following personnel will benefit from the course:

  • Pharmaceutical Development
  • Quality Control
  • Validation
  • Regulatory Affairs
  • Quality Assurance
  • Project Management
Day 01(8:00 AM - 4:30 PM)
  • Registration Process: 8:30 AM – 9:00 AM
  • Session Start Time: 9:00 AM
  • The CMO Business Model
  • What is CMO Oversight?
  • Regulatory Requirements for CMO Oversight
  • FDA Expectations and Warning Letters
  • Structuring Your Organization for CMO Oversight
    • Manufacturing
    • Chemistry / Laboratory
    • Quality Assurance
    • Regulatory Affairs
    • Project Management
    • Group Exercise # 1- Structuring Your Organization
  • CMO Selection and Qualification
    • Key Selection / Qualification Criteria
      • Overall Considerations
      • Considerations for API CMOs
      • Considerations for Drug Product CMOs
      • Considerations for Aseptic Manufacturing CMOs
      • Considerations for Testing Laboratory CMOs
    • Evaluating CMOs vs. Selection / Qualification Criteria
    • Group Exercise # 2- CMO Selection and Qualification
  • CMO Qualification Audits
    • Overall Considerations for CMO Qualification Audits
    • CMO Questionnaires
      • Risk Assessments for Use of Questionnaires
      • Evaluation of Questionnaire Responses
    • Audit Planning
      • Auditor Selection
      • Determining Audit Purpose / Scope
      • Audit Agenda
    • Audit Execution
      • Introductory Meeting / Orientation
      • Area Tours
      • Document Review / Interviews
      • Time Management
      • Audit Findings
    • Group Exercise # 3- Audit Agenda
  • The Quality Agreement
    • Regulatory Requirements
    • Elements of the Quality Agreement
    • Negotiating the Quality Agreement
    • Executing the Quality Agreement
    • Group Exercise # 4- Quality Agreement
Day 02(9:00 AM - 1:00 PM)
  • Getting to Know Your CMO
    • Understanding CMO Operations
    • Operational/Communication Style
    • How to Deal with the Seven CMO Personality Types
  • Review of Key CMO Records
    • Batch Records
    • Change Controls
      • Group Exercise # 5- Change Control Critique
    • Deviation Investigations / CAPA
      • Group Exercise # 6- Deviation Investigation Critique
    • OOS Investigations
      • Group Exercise # 7- OOS Investigation Critique
  • Hot Topic- Data Integrity
  • Routine CMO Audits
    • Audit Planning
    • Audit Execution
    • Differences from CMO Qualification Audits
  • Ongoing CMO Oversight
    • Overall Considerations
    • Elements of Effective Ongoing CMO Oversight
Andrew Campbell
Andrew Campbell Pharmaceutical Consultant - Quality & Compliance

Andrew Campbell has 25 years of pharmaceutical quality assurance and quality systems experience in both industry and consulting roles. Mr. Campbell has worked in clinical supply and commercial manufacturing environments, and has experience with integrated manufacturing and contract manufacturing business models. He has extensive expertise in the areas of deviation - CAPA, change control, GMP auditing, GMP training, and regulatory inspection preparation and management.

Working with large and small companies, Mr. Campbell has successfully developed, remediated and implemented key quality systems. He is a skilled GMP auditor, and has audited multiple API, drug product, packaging, testing, and distribution facilities. He is an experienced GMP trainer, and has developed customized and interactive training presentations for many companies. He has also provided FDA inspection support for several clients, including readiness training, on-site assistance during inspections, and authoring written responses to inspectional observations. Prior to becoming a consultant in 2007, Mr. Campbell worked for Ligand Pharmaceuticals as director of quality systems.

Register Now

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$1,699.00

Seminar One Registration

November 14-15, 2019, Tampa, FL
(For Registrations till October 20, 2019 - $1699)
(For Registrations after October 20, 2019 - $1999)


Your registration fee includes the workshop, all course materials and lunch.
For discounts on multiple registrations, contact customer care at +1-888-771-6965.

Other Registration Options

By order form / PO#

Payment Modes

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To pay by check please contact customercare@fdatrainingalert.com

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Register / Pay by Wire TransferPlease contact us at +1-888-771-6965 to get details of wire transfer option.

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

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 @ +1-888-771-6965 or email us @ customercare@fdatrainingalert.com

Payment:
Payment is required before 2 days of 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 from 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 FDATrainingAlert 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 FDATrainingAlert cancels the seminar, FDATrainingAlert 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 before 5 working days from the seminar date. Please bring the pass to the venue of the event.

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

How to Reach »
Driving Directions From Tampa International Airport – TPA: 2.5 miles NW
  • Take the exit for Spruce Street
  • Stay in the right hand lane
  • At the 2nd light turn right onto Westshore Blvd. The hotel will be approx. 1/2 mile down on the left on the corner of Westshore and Cypress.
Driving Directions From St Petersburg-Clearwater International Airport – PIE: 12.7 miles E
  • Take I-275 N over the Howard Frankland Bridge to the Kennedy exit (39A).
  • Take a right on Kennedy.
  • Then make a left onto North Westshore Blvd. Hotel will be on the right.

Other Transportation

Bus Station
  • Greyhound Bus Lines: 4.8 miles W
Train Station
  • Amtrak: 5 miles W

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

Partners/Sponsors

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@fdatrainingalert.com or call: +1-650-238-9656

Media Partner:

Media Partner

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