ComplianceOnline

Raw material requirements in a cGMP environment are often overlooked as a company develops new products. Depending on the product being developed, e.g., tablets and capsules vs. biotechnology products, as few as fifteen to twenty or as many as sixty raw materials need to be sourced before the process can be moved from initiation through completion.

This highly interactive two day seminar on raw material requirements in a cGMP environment will:

  • Consider Health Canada, FDA, USP and EP requirements.
  • Examine a variety of the issues surrounding raw materials to include what materials should be tested and to what extent during Phase 1, 2, 3 and commercial production.
  • Cover testing requirements during each phase and what may be optional (regulatory risk) until the product moves to its next phase.
  • Determine what options exist - even within a Phase 2 or Phase 3 testing framework.
  • Discuss compendial vs. non-compendial testing and how to respond when no method is available.
  • Discuss how a 90 percent vs. a 90.0 percent minimum purity analysis can delay initiation of testing.
  • Explore the number of lots required for testing before reduced testing might occur and why some companies don't accept this route.
  • Review the use of individual samples vs. composite samples for testing.
  • Explore ASQ testing to include how to choose attributes and sample size.

The objective of this two day seminar is to explore raw materials and their requirements – issues and solutions. It will also explore how water impacts the final product since water is the single largest raw material that is used within most processes. Another objective is to assure that your organization is maintaining itself within a cGMP compliance framework. Case studies to include Warning Letters will be discussed to illustrate regulatory raw material issues.

Learning Objectives:

Upon completing this course on raw material requirements in a cGMP environment participants will:

  • Understand how various types of raw materials may impact the user.
  • Learn of the impact of raw materials in the timely production of a product.
  • Determine the single most used raw material in large molecule production and what it means to the user.
  • Find the sources of analyses assistance for raw materials.
  • Appreciate the requirements for Phase 1 through commercial manufacturing.
  • Initiation of additional testing -- when?
  • Examination of regulatory risk (ICH Q9).
  • Why use compendial testing in lieu non-compendial testing.
  • Testing requirements -- when is enough?
  • The impact of ASQ on sample size and attribute testing.
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

Who Will Benefit:

  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Manufacturing engineers
  • Quality engineers
  • Quality auditors
  • Quality Control
  • Microbiology
  • Document control specialists
  • R & D
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Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • The various raw materials and the user impact
  • Impact of raw materials in the timely production of a product
  • The impact of the single most used raw material in large molecule production and its impact upon the user
  • The regulatory requirements for Phase 1 through commercial manufacturing
  • The use of additional testing – does one only review the C of A
Day 02(8:30 AM - 4:30 PM)
  • The use of compendial testing in lieu of non-compendial testing – pros and cons
  • Regulatory risk (ICH Q9) with raw materials
  • Testing requirements – how to sample
  • Testing requirements – how to test
  • The impact of ASQ on sample size and attribute testing
  • Case Studies – Time to apply the previous two days
  • Warning Letter examples
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Barry A. Friedman

Barry A. Friedman, Ph.D
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena

Barry A. Friedman, PhD, is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology.

Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international.

Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n’ Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.

Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology.

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Seminar One Registration (USD)

June 29-30, 2017, Vienna, Austria
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(For Registrations till May 10, 2017 - $2099)
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(For Registrations after June 5, 2017 - $2299)

$2,399.00

Seminar One Registration (USD) (With 2 Nights Stay)

June 29-30, 2017, Vienna, Austria

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Location:

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(Venue to be announced shortly)

June 29-30, 2017

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Testimonials

See What People Say About Us

The seminar was well coordinated and organized. I like how speaker point out to links for more details.

Quality Control,

Gilead Science

The interaction between the presenter and participant is great. ComplianceOnline.com provides useful courses and practical seminars.

QC Lab Supervisor,

Revance Therapeutics

One of my colleagues referred me to this seminar. The subjects are well chosen and presenter is very knowledgeable. I liked the session on "ASQ Sampling, Supplier Change Notifications".

QC Sr. Specialist,

Raw Material Support,

Bayer HealthCare LLC

I like the info provided about "Vendor Qualification Requirements".

Senior Associate,

Quality Assurance,

Arbutus Biopharma Corporation

I was looking for a good overview of the RM World and speaker provided in-depth knowledge about it. I liked all sessions of this seminar. Speaker is very knowledgeable.

Supervisor,

Laboratory Operations,

Upsher-Smith Laboratories, Inc.

I liked the case studies and presentation given on day 2 of seminar.

Director CMC,

Dermira, Inc.

Real world examples of warning letters are very useful.

Supplier Quality,

Sanofi Pasteur Inc.

Length of the program is appropriate and the support material are very useful.

Chemistry Specialist,

Bayer HealthCare LLC

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Local Attractions of Austria, Vienna

Schonbrunn Palace

Schonbrunn Palace

Schonbrunn Palace is a former imperial summer residence located in Vienna. The 1,441-room Baroque palace is one of the most important architectural, cultural, and historical monuments in the country. Since the mid-1950s it has been a major tourist attraction. The history of the palace and its vast gardens spans over 300 years, reflecting the changing tastes, interests, and aspirations of successive Habsburg monarchs. The Great Parterre of Schönbrunn is lined with 32 sculptures, which represent deities and virtues. The sculpted garden space between the palace and the Sun Fountain is called the Great Parterre. The French garden contains, among other things, a maze. The complex includes many more attractions: besides the Tiergarten, an orangerie erected around 1755, staple luxuries of European palaces of its type, a palm house is noteworthy. Western parts were turned into English garden style in 1828–1852. The area called Meidlinger Vertiefung to the west of the castle was turned into a play area and drill ground for the children of the Habsburgs in the 19th century. At this time it was common to use parks for the military education of young princes.

Belvedere Palace

Belvedere Palace

The Belvedere is a historic building complex in Vienna, Austria, consisting of two Baroque palaces (the Upper and Lower Belvedere), the Orangery, and the Palace Stables. The buildings are set in a Baroque park landscape in the third district of the city, on the south-eastern edge of its centre. It houses the Belvedere museum. The grounds are set on a gentle gradient and include decorative tiered fountains and cascades, Baroque sculptures, and majestic wrought iron gates. The various sections of the original orangeries annexed to the Marble Hall were returned to their original condition and now provide space for the new exhibition rooms. The magnificent Baroque state rooms – the Marble Gallery, the Golden Room, and the Hall of Grotesques – remain unchanged and are open to the public.

Prater

Prater

The Prater is a large public park in Vienna's 2nd district (Leopoldstadt). The Wurstelprater amusement park, often simply called "Prater", lies in one corner of the Wiener Prater and includes the Wiener Riesenrad Ferris wheel. On the grounds of modern-day Kaiserwiese, an attraction called "Venice in Vienna” was established in 1895 by Gabor Steiner. The area included an artificial lagoon to simulate the canals of Venice, Italy. In 2004, major renovations to the Wurstelprater began, and a new underground railway line was finished and brought into service on May 11, 2008, which includes three stops along the Prater. The Hauptallee (main avenue) is the main artery, lined with horse chestnut trees, closed to motorists and known to sports enthusiasts from the annual Vienna Marathon. The Wiener Prater is home to the Liliputbahn, a narrow gauge railway. Another unusual object to be found in the Wiener Prater is the Republik Kugelmugel (Republic of Kugelmugel), a spherical micronation. The Wiener Prater also houses a planetarium and the Prater Museum.

Vienna Ring Road

Vienna Ring Road

The Ring Road (German: Ringstraße) is a circular ring road surrounding the Innere Stadt district of Vienna and is one of its main sights. Constructed in the mid-19th century after the dismantling of the city fortification walls, its architecture is typical of the eclectic, historicist style called Ringstraßenstil (Ring Road Style) of the 1860s to 1890s. Known for its unique architectural beauty and history, it has also been called the "Lord of the ring roads", and is inscribed by UNESCO as part of Vienna's World Heritage Site. Sigmund Freud was known to take a daily recreational walk around the Ring. The Ringstraße has several sections. It surrounds the central area of Vienna on all sides, except for the northeast, where its place is taken by the Franz-Josephs-Kai, the street going along the Donaukanal (a branch of the Danube).

Kunsthistorisches Museum

Kunsthistorisches Museum

The Kunsthistorisches Museum (English: "Museum of Art History", also often referred to as the "Museum of Fine Arts") is an art museum in Vienna. Housed in its festive palatial building on Ringstraße, it is crowned with an octagonal dome. The term Kunsthistorisches Museum applies to both the institution and the main building. It is the largest art museum in the country. It was opened around 1891 at the same time as the Naturhistorisches Museum, by Emperor Franz Joseph I of Austria-Hungary. The two museums have similar exteriors and face each other across Maria-Theresien-Platz. The museum's primary collections are those of the Habsburgs, particularly from the portrait and armour collections of Ferdinand of Tirol, the collections of Emperor Rudolph II, and the collection of paintings of Archduke Leopold Wilhelm.

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