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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$1,799.00

Seminar One Registration (USD)

June 29-30, 2017, Copenhagen, Denmark
(For Registrations till May 25, 2017 - $1799)
(For Registrations till June 5, 2017 - $1999)
(For Registrations after June 5, 2017 - $2099)

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June 29-30, 2017, Copenhagen, Denmark
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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.

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Location

Copenhagen Marriott Hotel
Kalvebod Brygge 5, 1560,
Copenhagen V, Denmark
Tel: +45-8833-9900

June 29-30, 2017

How to Reach

General Driving Directions:

Driving directions from Copenhagen Airport – CPH - 4.8 miles SE:
  • Take the Highway E20 in direction of City Centre.
  • Cross Sjaellandsbroen and turn right.
  • 2 km further, the Copenhagen Marriott Hotel is located on your right.

Other Transportation

Bus Station
  • Nearby Copenhagen Central Station 0.3 miles NW
Subway Station
  • Christianshavn 1.2 miles E
Train Station
  • Kobenhavns Hovedbanegard (Copenhagen Central Station) 0.4 miles W

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.

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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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If you wish to sponsor this event please contact Cruise Webster: cwebster@complianceonline.com or call us: (207) 576-4173

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Local Attractions of Copenhagen, Denmark

Tivoli Gardens

Tivoli Gardens

Tivoli Gardens is a famous amusement park and pleasure garden in Copenhagen, Denmark. The park opened on 15 August 1843. With 4.733 million visitors in 2015, Tivoli is the second-most popular seasonal theme park in the world, the most-visited theme park in Scandinavia and the fourth most-visited in Europe, only behind Disneyland Paris, Europa-Park Rust and the Efteling. The park is best known for its wooden roller coaster, Rutschebanen, built in 1914. It is one of world's oldest wooden roller coasters that is still operating today. Another roller coaster, Dæmonen (The Demon), features an Immelmann loop, a loop, and a zero-G roll all during the ride time of just one minute and forty six seconds. The world's second tallest carousel, The Star Flyer, opened in Tivoli in 2006.

National Museum of Denmark

National Museum of Denmark

The National Museum of Denmark (Nationalmuseet) in Copenhagen is Denmark’s largest museum of cultural history, comprising the histories of Danish and foreign cultures alike. The museum's main building is located a short distance from Strøget at the center of Copenhagen. It contains exhibits from around the world, from Greenland to South America. Additionally, the museum sponsors SILA - The Greenland Research Centre at the National Museum of Denmark to further archaeological and anthropological research in Greenland. The museum covers 14,000 years of Danish history, from the reindeer-hunters of the Ice Age, Vikings, and works of religious art from the Middle Ages. The National Museum keeps Denmark’s largest and most varied collection of objects from the ancient cultures of Greece and Italy, the Near East and Egypt

Amalienborg

Amalienborg

Amalienborg is the home of the Danish royal family. It consists of four identical classical palace façades with rococo interiors around an octagonal courtyard. In the centre of the square is a monumental equestrian statue of Amalienborg's founder, King Frederick V. Amalienborg was originally built for four noble families; however, when Christiansborg Palace burned on 26 February 1794, the royal family bought the palaces and moved in. Over the years various kings and their families have resided in the four different palaces.

Strøget

Strøget

Strøget is a pedestrian, car free shopping area in Copenhagen. This popular tourist attraction in the centre of town is one of the longest pedestrian shopping streets in Europe at 1.1 km. Located at the centre of the old city of Copenhagen, it has long been one of the most high-profile streets in the city. The pedestrianisation of Strøget in 1962 marked the beginning a major change in the approach of Copenhagen to urban life; following the success of the initiative the city moved to place a much greater emphasis on pedestrian and bicycle access to the city at the expense of cars. Many of the city's most famous and expensive stores, such as Illums Bolighus, Magasin du Nord, and the Royal Copenhagen Porcelain Factory are located along the strip, as well as some of the most famous and expensive luxury brand chain stores in the world. It also features a multitude of souvenir shops and fast food outlets.

Rundetaarn

Rundetaarn

The Rundetaarn is a 17th-century tower in central Copenhagen. One of the many architectural projects of Christian IV, it was built as an astronomical observatory. It is most noted for its equestrian staircase, a 7.5-turn helical corridor leading to the top, and for the expansive views it affords over Copenhagen. The tower is part of the Trinitatis Complex which also provided the scholars of the time with a university chapel, the Trinitatis Church, and an academic library which was the first purpose-built facilities of the Copenhagen University Library which had been founded in 1482. Today the Round Tower serves as an observation tower, a public astronomical observatory and a historical monument. In the same time the Library Hall, located above the church and only accessible along the tower's ramp, is an active cultural venue with both exhibitions and a busy concert schedule.

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