San Francisco Professional Events List


Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)


Date
Nov 15, 2018 - 08:00 AM
Organizer
NY Events List
Venue
DoubleTree by Hilton San Francisco Airport
Location
835, Airport Blvd Address 2

San Francisco,
CA,
USA,
ZIP: 94010
Phone:

Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)


*** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! ***
REGISTER TODAY!

 

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.

 

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 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

 

AGENDA


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


SPEAKER

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.

 

Please contact the event manager Marilyn ([email protected] ) below for:
- Multiple participant discounts
- Price quotations or visa invitation letters
- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)
- Event sponsorships

NO REFUNDS ALLOWED ON REGISTRATIONS
Service fees included in this listing.
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Event Categories
Keywords: fun, assessment , business , Clinical , communication , design , development , environment, Fun , function




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