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An effective quality system program, along with several regulatory requirements, includes the documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents. To control this process, one must have both a defined change control procedure that outlines responsibilities and documentation requirements and also a form by which required information is recorded. The effectiveness of these items will determine the success of your change control program and help assure regulatory auditors that your equipment, utilities and systems remain in a state of control.

This seminar will concentrate on three major points:

  • The regulatory requirements for change control and what it applies to.
  • How to develop a change control SOP that will define what is required, responsibilities, and a means to quickly provide summaries of changes to investigators.
  • What are some of the common deficiencies cited by regulatory auditors?

In addition, the seminar will also highlight some of the benefits that a well maintained change control program provides to a company along with reviewing when change control is not required. Attendees will be able to ask questions on issues relating to their own change control procedure.

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:

This seminar will define the regulatory expectations, the typical components of a change control procedure and typical form, typical deficiencies cited by regulatory auditors, along with the current proposed FDA guidance on addressing out of specification results. Attendees will have plenty of opportunity to ask questions and actual case studies will be used to highlight various topics given.

  • Review the current regulatory requirements for change control.
  • Discuss when change control needs to be implemented and the main items it should cover.
  • What are the major sections that need to be included in a change control procedure?
  • What are the typical industry challenges associated with change control procedures?
  • Review the benefits that a well-controlled change control process can provide.
  • What are the most common deficiencies cited by regulatory auditors when auditing change control programs?
  • Discuss when change control needs to be implemented and the main items it should cover.
  • What are the major sections that need to be included in a change control procedure?
  • What are the typical industry challenges associated with change control procedures?
  • Review typical evaluation methods used for determining probable cause such as fault tree, fish diagrams, etc.

Who will Benefit:

This course is designed for people who are involved with the manufacture of drug products, medical devices and even contract manufacturers. The following personnel will benefit from the course:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Suppliers and Vendors
  • Process owners
  • Quality engineers
  • Quality auditors

Topic Background:

It is said that the two things no one can avoid in life are death and taxes, but in industry, these items are change control and out of specification results that will eventually happen. How we document them and their evaluation are critical to an effective quality system program. In review of the top 10 most cited GMP deficiencies, these two topics have routinely made the top 10 list for the last five years and understanding how best to address them will help companies avoid getting cited for the same issues.

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Day 01(8:30 AM - 4:30 PM)
  • Registration Process - (8:30 am till 9:00 am)
  • Session 1: Review the current regulatory requirements for change control. Discuss when change control needs to be implemented and the main items it should cover.
  • Session 2: What are the major sections that need to be included in a change control procedure?
  • Session 3: What are the typical industry challenges associated with change control? Review the benefits that a well-controlled change control process can provide.
  • Session 4: What are the most common deficiencies cited by auditors when reviewing change control programs? Review the current regulatory requirements for change control.
Day 02(8:30 AM - 4:30 PM)
  • Session 5: Discuss when change control needs to be implemented and the main items it should cover.
  • Session 6: What are the major sections that need to be included in a change control procedure?
  • Session 7: Review the current FDA Guidance for the investigation of Out of specification results (OOS).
  • Session 8: Review typical evaluation methods used for determining probable cause such as fault tree, fish diagrams, etc. Discuss actual case studies to highlight topics covered. Question and answer period from the attendees

Each days training will include actual case studies to highlight topics covered, review of applicable forms that can be used as templates for change control, or audit checklists, etc. Attendees will have ample opportunity to ask questions regarding current industry practices or their own company practices.

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Kenneth Christie

Kenneth Christie,
Chief Operating Officer, VTS Consultants Inc and ISPE Examination Development Committee (EDC) Member

Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of quality assurance and validation management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the chief operating officer for VTS Consultants, Inc., located in Amherst, MA. His responsibilities specifically include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, medical devices, APIs and solid dosage processing equipment, utilities, and systems on a global basis. He also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.

Mr. Christie was the validation manager at Parke-Davis' Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.

Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, he serves as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.

Mr. Christie has a BS degree in biology from Shippensburg State University (PA) and an executive MBA degree from Michigan State.

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$1,199.00

Seminar One Registration

December 14-15, 2017, Newark, NJ
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(For Registrations after November 20, 2017 - $1499)

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Seminar One Registration (With 2 Nights Stay)

December 14-15, 2017, Newark, NJ

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Location :

Newark, NJ
(Venue to be announced shortly)

December 14-15, 2017

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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.

Newark Symphony Hall

Newark Symphony Hall:

Newark Symphony Hall at 1020 Broad Street in Newark, Essex County, New Jersey, was built in 1925 and added to the National Register of Historic Places in 1977. Originally built by the Shriners at a cost of more than $2 million as Salaam Temple and colloquially known as The Mosque, the four-story building has been Newark Symphony Hall since 1964. The interior features Greek and Egyptian motifs, marble columns, a crystal chandelier, gold-leaf fret work and two-columned side promenades. The neo-classical building was design by Frank Grad, a prominent Newark architect, whose work includes the Lefcourt Newark Building and many others downtown. The 3,500-seat main concert hall is named for Sarah Vaughan, a native Newarker, and is renowned for its acoustics.

Military Park

Military Park:

Military Park is a 6-acre city park in downtown Newark. It is a nearly triangular park located between Park Place, Rector Street and Broad Street. From 1667, when the city was planned, until 1869 it was a training ground for soldiers. In 1869, it became the town commons. The New Jersey Historical Society, Military Park Building and the New Jersey Performing Arts Center are located across Park Place from the park. A $3.25 million renovation was announced in February 2012 and the park reopened in June 2014.

John Ballantine House

John Ballantine House:

The John Ballantine House was the home of Jeannette Boyd (1838–1919) and John Holme Ballantine (1834–1895). John was the son of Peter Ballantine, founder of the Ballantine beer brewery, and became president of the family business in 1883 after his father died. The house was built in 1885 at 49 Washington Street in the Washington Park section of Newark, Essex County, New Jersey. It is now part of the Newark Museum and is open to the public for tours.

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