Course Description:
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:
Who Will Benefit:
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Manufacturing engineers
- Quality engineers
- Quality auditors
- Quality Control
- Microbiology
- Document control specialists
- R & D
Course Outline:
| Day One (8:30 AM – 4:30 PM) | Day Two (8:30 AM – 4:30 PM) | ||
|
Registration Process: 8:30 AM – 9:00 AM
|
|
Meet Your Instructor
 |
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. |
Register Now
Online using Credit card
Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]
Other Registration Option
- Download the Order Form
- Fill this form with attendee details & payment details
- Fax it to +1-650-362-2367, or
- Email it to [email protected]
Payment Mode
ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA
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 @ [email protected]
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 $200 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 ($200) 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.
|
Local Attractions
Museu Picasso
The Museu Picasso, located in Barcelona, houses one of the most extensive collections of artworks by the 20th-century Spanish artist Pablo Picasso. With 4,251 works exhibited by the painter, the museum has one of the most complete permanent collections of works. The museum is housed in five adjoining medieval palaces in Barcelona's La Ribera and is located on Montcada Street in the (Bank District) of Barcelona. It opened to the public on 9 March 1963, becoming the first museum dedicated to Picasso's work and the only one created during the artist's life. It has since been declared a (museum of national interest) by the Government of Catalonia.
Camp Nou
Camp Nou, often referred to as the "Nou Camp", is a football stadium in Barcelona. It has been the home of FC Barcelona since its completion in 1957. With a seating capacity of 99,354, it is the largest stadium in Spain by capacity. It is also the largest stadium in Europe and the third largest association football stadium in the world in terms of capacity. It has hosted numerous international matches at a senior level, including a 1982 FIFA World Cup semi-final match, two UEFA Champions League finals and the football competition at the 1992 Summer Olympics.
Park Guell
The Park Guell is a public park system composed of gardens and architectonic elements located on Carmel Hill, in Barcelona, Catalonia. Carmel Hill belongs to the mountain range of Collserola — the Parc del Carmel is located on the northern face. Park Güell is located in La Salut, a neighborhood in the Gràcia district of Barcelona. The park was built between 1900 and 1914 and was officially opened as a public park in 1926. The park was originally part of a commercially unsuccessful housing site, the idea of Count Eusebi Guell, after whom the park was named. It was inspired by the English garden city movement; hence the original English name Park. In 1984, UNESCO declared the park a World Heritage Site under “Works of Antoni Gaudí.”
La Rambla
La Rambla is a street in central Barcelona, popular with tourists and locals alike. A tree-lined pedestrian mall, it stretches for 1.2 kilometres connecting Plaça de Catalunya in the centre with the Christopher Columbus Monument at Port Vell. La Rambla forms the boundary between the quarters of Barri Gòtic, to the east, and El Raval, to the west.
Gothic Quarter
The Gothic Quarter is the centre of the old city of Barcelona. It stretches from La Rambla to Via Laietana, and from the Mediterranean seafront to Ronda de Sant Pere. Despite several changes undergone in the 19th and early 20th century, many of the buildings date from Medieval times, some from as far back as the Roman settlement of Barcelona. Remains of the squared Roman Wall can be seen around Tapineria and Sots-Tinent Navarro to the north, Avinguda de la Catedral and Plaça Nova to the west and Carrer de la Palla to the south. El Call, the medieval Jewish quarter, is located within this area too. The Barri Gòtic retains a labyrinthine street plan, with many small streets opening out into squares. Most of the quarter is closed to regular traffic although open to service vehicles and taxis.
Casa Mila
Casa Mila, popularly known as La Pedrera, is a modernist building in Barcelona. It was the last civil work designed by Catalan architect Antoni Gaudí, built between the years 1906 and 1912. At the time, it was controversial because of the undulating stone facade and twisting wrought iron balconies and windows designed by Josep Maria Jujol. Architecturally it is considered structurally innovative, with a self-supporting stone front and columns, and floors free of load bearing walls. Also innovative is the underground garage. In 1984 it was declared a World Heritage Site by UNESCO. Currently, it is the headquarters of the Catalunya-La Pedrera Foundation, which manages the exhibitions, activities and public visits at Casa Mila.
