ComplianceOnline

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

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Register Now

Online using Credit card

$1,899.00

Seminar One Registration

July 27-28, 2017, San Francisco, CA

$8,799.00
$11,394.00 (22%)*

Save $2,595.00

Special Group Discount Register for Six attendees

July 27-28, 2017, San Francisco, CA
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left




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.

Online using Credit card

$1,499.00

Seminar One Registration

September 21-22, 2017, Newark, NJ
(For Registrations till July 30, 2017 - $1499)
(For Registrations till August 30, 2017 - $1699)
(For Registrations after August 30, 2017 - $1899)

$2,099.00

Seminar One Registration (With 2 Nights Stay)

September 21-22, 2017, Newark, NJ

$6,799.00
$8,994.00 (24%)*

Save $2,195.00

Special Group Discount Register for Six attendees

September 21-22, 2017, Newark, NJ
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left




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.

1

San Francisco, CA
July 27-28, 2017

Hotel

Hilton San Francisco Airport Bayfront
600 Airport Blvd,
Burlingame, CA, 94010, USA

Tel: +1-650-340-8500

How to Reach

General Driving Directions:

Driving directions from San Francisco International Airport – 4 miles:
  • Exit airport 101 South towards San Jose.
  • Take Broadway/Burlingame exit.
  • Take 2nd right to overpass to other side of freeway. 1st light, turn right.
  • Next light turn left onto Airport Blvd. Hotel is located in 1 mile.
Driving directions from San Jose International Airport – 32 miles:
  • Start out going Southeast on Airport Blvd.
  • Turn slight Left to CA-87/ Skyport Dr.
  • Merge onto CA -87 N. via the ramp to US-101 N.
  • Take US-101 N. Take Anza exit and turn right on Airport Blvd. Hotel is on the left.
Driving directions from Metropolitan Oakland International – 32 miles:
  • Exit airport and turn left onto Davis/CA-61.
  • Merge onto I-880 toward San Jose.
  • Take exit 27 toward CA-92 toward San Mateo/Half Moon Bay.
  • Cross the bridge and merge onto US-101 N. Exit Peninsula Ave, exit 417B. Left on Airport to the hotel.

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.

2

Newark, NJ
September 21-22, 2017
(Venue to be announced shortly)

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

Local Attractions of Newark, NJ

Newark Museum:

Newark Museum:

The Newark Museum, in Newark, Essex County, is the state's largest museum. It holds fine collections of American art, decorative arts, contemporary art, and art from Asia, Africa, the Americas, and the ancient world. Its extensive collections of American art include works by Hiram Powers, Thomas Cole, John Singer Sargent, Albert Bierstadt, Frederick Church, Childe Hassam, Mary Cassatt, Edward Hopper, Georgia O'Keeffe, Joseph Stella, Tony Smith and Frank Stella. The Newark Museum's Tibetan galleries are considered among the best in the world. The collection was purchased from Christian missionaries in the early twentieth century.

Prudential Center

Prudential Center:

Prudential Center is a multi-purpose indoor arena in the central business district of Newark. Opened in 2007, it is the home of the National Hockey League's (NHL) New Jersey Devils and the NCAA's Seton Hall Pirates men's basketball team. The arena seats 16,592 patrons for hockey and 18,711 for basketball. Fans and sports writers have affectionately nicknamed the arena "The Rock" in reference to the Rock of Gibraltar, the corporate logo of Prudential Financial, a financial institution that owns the naming rights to the arena and is headquartered within walking distance. In December 2013, the arena ranked third nationally and ninth internationally for self-reported annual revenue. It is located two blocks from Newark Penn Station in downtown Newark, just west of Newark's Ironbound district, making it easily accessible via New Jersey Transit, PATH, Newark Light Rail, and Amtrak.

Branch Brook Park

Branch Brook Park:

Branch Brook Park is a county park of Essex County, located in the North Ward of Newark, between the neighborhoods of Forest Hill and Roseville. A portion of the park is also located within the Township of Belleville. At 360 acres, Branch Brook Park is the largest public park in the city of Newark. The park is noted for the largest collection of cherry blossom trees in the United States, with over 4,300 in more than fourteen different varieties collectively called Cherryblossomland, as well as its spectacular Cherry Blossom Festival each April. The festival attracts approximately 10,000 visitors each April. During World War II, the park's grounds served a tent city for recruits, as well as a landing strip for airplanes of the United States Postal Service. To the park’s east is the Cathedral of the Sacred Heart Basilica, one of the largest cathedrals in the United States.

Cathedral Basilica of the Sacred Heart

Cathedral Basilica of the Sacred Heart, Newark, New Jersey:

The Cathedral Basilica of the Sacred Heart, the fifth-largest cathedral in North America, is the seat of the Roman Catholic Archdiocese of Newark. It is located at 89 Ridge Street in the Lower Broadway neighborhood of Newark, New Jersey. Envisioned as a fitting monument to the faith, construction began in 1899 and was finished in 1954. The original design called for an English/Irish-gothic church, but plans were later modified in favor of a French-gothic style. The Cathedral Basilica holds concerts open to the public throughout the year and it has the largest pipe organ ever built by the Schantz Organ Co. which includes 154 ranks playable from two consoles.

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

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