General Course Description:
During this two-day in person seminar, day one will focus on Application of Sanitizers, Disinfectants Use and Sterilants in a GMP Controlled and Classified Environment, and on the second day, the speaker will address Revision of the FDA Endotoxin Test for Human Parentaeral Drugs, Biological Products and Medical Devices. While the first part of the instruction will describe how to clean, sanitize and disinfect within a controlled and classified environment, the second day will focus on the need for assurance that your facilities and products are devoid of endotoxin. These two courses may be taken together in sequence or individually.
Day 1 |
Day 2 |
||
Course Description:Microbiology plays a role throughout the manufacture of pharmaceutical products. Both non-sterile and sterile products are susceptible to the microorganisms they contact during the manufacturing process which may include raw materials, in-process operations and the final product. The environmental and utility systems must also be maintained as must the packaging components, manufacturing equipment, and personnel. To maintain this controlled process and environment, sanitizers, disinfectants and sterilants (sporicides) are essential. Maintaining this controlled environment also requires knowledge of the microorganisms present and their susceptibility to various sanitizers, disinfectants and sterilants. Whether the final product is non-sterile or sterile, bioburden exists throughout the process and/or within the product's environment. This seminar will illustrate best practices for a critical review of the overall microbiological process, which will determine whether the critical in-process points permit the final product to meet its acceptance criteria. Whether you are auditing a raw material supplier, a testing laboratory, or your own facilities, you should be aware of the critical role the microorganisms play throughout. This seminar will instruct attendees on the importance of being aware of the various microbiological related documents, e.g., raw material sampling criteria, in-process, API, final product, environmental and utilities, to determine whether the SOPs, internal validations as well as government and other regulatory body documents are being maintained to control the bioburden and permit the final product to enter the marketplace as microbiologically safe. The objective of day one of this interactive seminar is to:
USP<1072> Disinfectants and Antiseptics will be used as a reference throughout the course. Learning Objectives:
|
Course Description:On Tuesday, July 12, 2011, the FDA posted a notice on their website that they had withdrawn the 1987 Guideline on Validation of the Limulus Amebocyte Lysate Test as an End Product Endotoxin Test for Human Parenteral Drugs, Biological Products and Medical Devices. They advised that the 1987 Guideline is considered obsolete and does not reflect the agency's current thinking on the topic. In lieu of this document, the FDA advised that they would be issuing a Guidance for Industry on Pyrogen and Endotoxins Testing: Questions and Answers during the November/ December 2011 timeframe. After much delay, this new guidance was released in June 2012. The FDA referenced, however, three documents that they believe have more than offset the previous FDA guidance that was withdrawn. They advise that these documents be referenced for the fundamental principles of the gel clot, photometric and kinetic test methods. This new, revised guidance supplements the above three documents and addresses those issues that may be subject to misinterpretation, not covered in compendial procedures or in the previously available guidance document. The objective of day two of this interactive seminar is to:
Examples of FDA Warning Letters which illustrate problems associated with endotoxin will also be provided. Learning Objectives:
|
Who Will Benefit:
- Manufacturing
- Product Development
- Project Management
- Quality Assurance
- Quality Control
- Regulatory Affairs
- Regulatory Compliance
- Validation
Topic Background - Day 1:
The determination of which disinfectant to use is largely dependent upon the site of application and the type of microorganism present. For example, gram-positive cocci are very easy to kill, while spore forming rods and fungi are more resistant. Other elements that need to be considered include the biocidal activity and its contact time, surface of application, concentration of microorganisms, and secondary issues to include water hardness and organic materials. In addition, surface films may also interfere with the direct contact of the microorganism and the disinfecting agent. Any objectionable or specified microorganisms that may be encountered during the procurement of raw materials and its processing must also be considered.
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
|
Course Title: Revision of the FDA Endotoxin Test for Human Parentaeral Drugs, Biological Products and Medical Devices
|
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
South Beach:
South Beach is the quintessential Miami hot spot. From shopping to partying, this area of Miami Beach is well-known for being a trendy locale.
Miami Sea Aquarium:
It is a 38-acre (15 ha) oceanarium (oldest in the US) located on the island of Virginia Key in Biscayne Bay. In addition to marine mammals, it houses fish, sharks, sea turtles, birds, reptiles, and manatees. The park offers daily presentations and hosts overnight camps, events for boy scouts, and group programs.
ZOO Miami:
It is the largest and oldest zoological garden in Florida and the only tropical zoo in the US. It houses over 2,000 animals on 740 acres (299 ha), 324 acres (131 ha) of which are developed.
Jungle Island
Jungle Island (formerly Parrot Jungle) is an interactive zoological park in Watson Island, Miami. It offers visitors a fun, educational opportunity to get an up-close look at tropical birds in replicas of their natural habitats.
Miami Science Museum& Planetarium:
Miami Science Museum offers children and adults alike an entertaining, educational experience. It's a great place to visit, whether you're on vacation, a school field trip or a weekend family outing.
Star Island:
Star Island, Biscayne Bay, Miami is an artificial island within Miami Beach. The houses are colossal and the architecture is worth taking a look at.
Coral Castle:
It is a stone structure created by the Latvian American eccentric Edward Leedskalnin (1887–1951) in Miami-Dade County at the intersection of South Dixie Highway (U.S. 1) and SW 157th Avenue. The structure comprises numerous megalithic stones each weighing several tons.
Oleta River State Park:
The Oleta River State Park is a 1,043-acre (4.22 km2) Florida State Park on Biscayne Bay. Although it offers a variety of recreational opportunities, the park is best known for miles of off-road bicycling trails, ranging from novice trails to challenging trails for experienced bicyclists.
