Two days workshop on
Production and Process Control: Building a Robust System
Date: Thursday, 31 August 2017 - Friday, 01 September 2017 | Location: Boston, MA | Download Workshop Brochure
Course " Production and Process Control: Building a Robust System" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Course Description
A medical device production system must be efficient, effective, and compliant. This includes the right controls- documented instructions, environmental control, adequate equipment properly installed and maintained, production software, properly controlled test equipment and validated processes. The requirements come from FDA QSR, ISO 13485:2003 and ISO 13485:2016.

This two-day workshop covers the essentials of production and process control. Beyond the fundamental elements, the workshop provides practical methods to help create a robust system for device production - one that can withstand a rigorous FDA Inspection. Exercises provide an opportunity to put the lessons into practice. Case studies, based on FDA Warning Letters and the Quality System Inspection Technique (QSIT), provide an opportunity to learn from the experience of other companies. The workshop includes the elements from the Medical Device Single Audit Program (MDSAP).

Learning Objectives
  • Understand the regulatory environment for device manufacturers including FDA QSR, ISO 13485:2003 and ISO 13485:2016
  • Learn the approach regulators use to check implementation including QSIT and MDSAP
  • Learn the requirements for installation and maintenance of production equipment
  • Understand how to manage inspection, measuring and test equipment, IM&TE
  • Learn the requirements for production and test software validation
  • Understand product verification requirements and records
  • Learn when to validate a process and the most common approach (IQ, OQ, and PQ)
  • Learn how to handle nonconforming product and keep the required records
  • Understand the role of quality plans, process flowcharts and process FMECAs
  • concepts of production process control
  • Learn the underlying statistical concepts including statistical distributions and decision making
  • Understand data types (attributes and variables)
  • Learn the SPC methods available for the data types
  • Understand the methods to calculate and use process capability
Why Should you Attend
Production and process control is the essence of medical device manufacturing. It provides the framework for making devices, verifying them, validating processes and handling problems. A device manufacturer's production needs to satisfy the regulatory requirements to avoid audit findings and pass FDA Inspections. By attending this workshop, you will learn the regulatory requirements and tools to help implement them.

Who will Benefit
  • Production Managers and Supervisors
  • Quality Managers and Supervisors
  • Quality Engineers
  • Manufacturing Engineering Managers and Supervisors
  • Manufacturing Engineers
  • Quality Management System Auditors
  • Risk Management Specialists
  • Regulatory Affairs and Compliance Staff

Day One (8:00 a.m. - 8:30 a.m.: Registration Process)

Part A - Establishing Production Controls
  • The development of the QMS (QSR, ISO 13485:2003, & ISO 13485:2016)
  • The current versions of the QMS (US, EU, & Canada)
  • Design output and design transfer
  • Developing quality plans
  • Writing procedures and instructions
  • Monitoring and controlling process parameters
  • Buildings and environmental control
  • Personnel
  • Contamination control
Part B - Manufacturing Equipment
  • Using Installation Qualification (IQ)
  • Equipment and OSHA standards
  • Developing maintenance schedules
  • Utilizing Total Productive Maintenance (TPM)
  • Measuring equipment effectiveness
Part C - Production Software
  • Identifying software used in production
  • Understanding the FDA guidance document
  • Extent of validation (risk based approach)
  • Excel spreadsheets as a common example
  • Developing a validation protocol and report
Part D - Inspection, Measuring and Test Equipment (IM&TE)
  • Accuracy and precision - what they mean
  • Traceability to national and international standards
  • When there are no standards
  • Documenting calibration status
  • Adjusting calibration intervals
  • The external calibration lab - purchasing an outsourced process
Part E - Production and Process Changes
  • Identifying changes
  • QSIT and design changes
  • Determining responsibility for changes
  • Change verification
  • Process validation and change control
Day Two

Part F - Process Validation
  • Determining the need for process validation
  • Defining a "high degree of assurance" - process capability
  • The common phases of process validation (IQ, OQ, & PQ)
  • Monitoring, control, and documentation of process parameters
  • The role of qualified operators
  • Documenting changes and investigating deviations
Part G - Acceptance Activities
  • Acceptance activities in the production flow
  • Acceptance as process control
  • Acceptance sampling - attributes & variables
  • Maintaining acceptance records
Part H - Process FMECA
  • The role of quality plans
  • Developing a flowchart
  • Identifying failure modes for process steps
  • Process Improvement
  • Analysis - RPNs
  • Linking ISO 14971:2007 risk management
Part I - Nonconforming Product & Corrective Action
  • Definitions - Correction & Corrective Action
  • Control and disposition of nonconforming product
  • Documenting nonconforming product in the Device History Record (DHR)
  • Corrective action as a process improvement technique

Daniel O'Leary - President, Ombu Enterprises, LLC

Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Register yourself for this brainstorming session Now . You can do single registration or group or register via P.O/Check or Wire.

Register Online
Single Registration
Special Group Discount
2 Attendees - Get 10% off
3 to 5 Attendees - Get 20% off
5+ Attendees - Get 30% off
Your registration fee includes the workshop, all course materials and lunch.
Register by P.O. / Check / Wire Transfer
Excited to join the workshop on "Production and Process Control: Building a Robust System" then register for the same by P.O. / Check / Wire Transfer. Call us Toll Free at (510)-857-5896 for any registration related assistance.

If you are Paying by Check:
Checks should be payable to Holkoi LLC and mailed to:
38780 Tyson Lane Suite 210 Fremont
California 94536, USA

Wire Transfer:
If you wish to pay by wire transfer. Call us toll free on 510-857-5896
Need Help!
In case you find difficulty in registering, availing the discount or need further information regarding the workshop, please feel free to contact our customer support team at (510)-857-5896 or send an email to We will help you.
Terms & Conditions to Register for the Workshop
Your registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for the workshop call us at (510)-857-5896 or email us at

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

If you are paying by check, the check should be payable to Online Compliance Panel and mailed to: 38780 Tyson Lane Suite 210 Fremont California 94536
The registration fee includes: The workshop; all related course materials; tea/coffee and lunch on both the days

Cancellations and Substitutions
For online registration, use your American Express, Visa or MasterCard.

In case you find difficulty in registering, call us at (510)-857-5896 or sent an email to We will help you to register hassle-free.

Any cancellation request received at least 10 calendar days prior to the start date of the event will receive a refund with a $200 administration fee deduction. No cancellations will be accepted - nor refunds issued - within 10 calendar days from the start date of the event.

On request (before the commencement of the workshop) a credit for the amount paid minus administration fees ($200) will be transferred to any future Online Compliance Panel event and a credit note will be issued. Substitutions may be made at any time.

Onsite registrations are also possible. However we accept only credit card payments and check payments. Conference material will be issued on the spot depending on the availability. In case it is not available we will send the material by post after the conference is over. In the event, Online Compliance Panel cancels the workshop; the company 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.

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

Documents to Carry
Online Compliance Panel will issue an electronic event pass to each registered candidate once the registration is confirmed. Please bring the pass to the venue of the event.

Boston, MA


Local Attractions :
Freedom Trail

The Freedom Trail leads you to 16 of the city's principal historic monuments and sites covering Old Granary Burying Ground, King's Chapel Burying Ground, Old South Meeting House (where the ringing speeches of patriots spawned the Boston Tea Party), and the Old State House. This is Boston's oldest public building and the site of the Boston Massacre.
Museum of Fine Arts Boston

This is one of the leading museums in the country. The Boston Museum of Fine Arts excels in its ancient Egyptian treasures, collections of Impressionist paintings, Asian and Persian fine arts, and major works from ancient Greece and the Middle East. Other popular museums in Boston are: Isabella Stewart Gardner Museum, Museum of Science, John F. Kennedy Presidential Library and Museum and the Children's Museum.
Faneuil Hall

Faneuil Hall (cradle of liberty) was built as a market hall built in 1740-42. Market stalls occupy the ground floor. The council chamber on the upper hall was the meeting place for revolutionaries in the 18th and 19th centuries. On its fourth floor lies the Ancient and Honorable Artillery Museum, which displays uniforms, weaponry, and paintings of significant battles. Quincy Market, North Market, and South Market are situated next to the Faneuil Hall Marketplace.
Fenway Park

Fenway Park is the most fabulous sports complexes in the country. The home of the Boston Red Sox exactly the same as it did when it opened on April 20, 1912. Main features are the 37-foot green wall. Because the park holds a least seating capacity of 33,871 spectators there is always a scarcity of tickets for the major leagues.
Beacon Hill

The south side of Beacon Hill has been the home of Boston's "old money" families, popularly known as "Brahmins." It is one of the most beautiful neighborhoods. Author Louisa May Alcott lived here from 1880 to 1888. The north side of Beacon Hill includes a sizable African American community, since the early 19th century.
Harvard Square and Harvard Art Museums

Harvard University, the oldest institution of higher learning in the United States was founded in 1636. Near to Harvard Yard is the Renzo Piano-designed home of the Harvard Art Museums, which includes three formerly separate collections, each of which is ranked high as major U.S. art museums. The Arthur M. Sackler Museum has some of the best Chinese bronzes as well as Chinese jade, Indian art, Japanese prints and Greco-Roman antiquities, particularly vases and sculptures.
Copley Square

The main architectural highlight here is the Trinity Church, a red sandstone building also known as Richardson Romanesque. Facing it, across a grassy lawn, is the Boston Public Library, the first publicly funded lending library in the country founded in 1848. Just beyond the Prudential Center is a 52-story tower, wherein you can visit the Skywalk observation deck for 360-degree view of Boston and its surroundings.
New England Aquarium

The New England Aquarium has more than 20,000 fish and aquatic animals among over 550 species. The artificial coral reef in the aquarium houses a large variety of tropical fish and underwater life including sharks, turtles, and moray eels. Outside the aquarium, visitors can watch harbor seals play, perform, and live in their enclosed habitat.