Application of Disinfectants and Sterilants to Control Microorganisms; FDA Endotoxin Test – Understanding the Latest Revision: 2-Day In-Person Seminar

By: Barry A. Friedman, Ph.D, Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena
Coming soon.. Please contact customer care for new schedule
Course “Application of Disinfectants and Sterilants to Control Microorganisms; FDA Endotoxin Test – Understanding the Latest Revision” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

We need the below information to serve you better

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:

  • Explore the use of various sanitizers, disinfectants and sterilants within a controlled environment
  • Learn which materials may be appropriate for your facilities’ operations
  • Ensure that you are complying with your own SOPs, governmental and regulatory guidances and regulations

USP<1072> Disinfectants and Antiseptics will be used as a reference throughout the course.

Learning Objectives:

  • Determining the implementation aspects of a cleaning and disinfection program
  • Determining the vendor qualification requirements
  • How to develop an application schedule
  • Determination of how application schedules apply to commissioning of a facility and after a shutdown
  • Learn the impact of sanitizers, disinfectants and sporicides on various common microorganisms found within a pharmaceutical facility
  • Impact of product expiration dating and regulatory implications
  • Understand the use of coupons and liquid suspensions – their advantages and disadvantages
  • Understand the regulatory expectations of sanitizers, disinfectants and sporicides
  • Monitoring and interpretation of the results of the cleaning and disinfection program
  • Understand resistance and rotation of disinfectants and its meaning to facilities

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:

  • Explore the new Guidance for Industry on Pyrogen and Endotoxins Testing which addresses those issues that may be subject to misinterpretation and are not covered in compendial procedures or in the currently available guidance documents
  • Understand how they impact testing within the typical quality control laboratory

Examples of FDA Warning Letters which illustrate problems associated with endotoxin will also be provided.

Learning Objectives:

  • Review of the current testing requirements
  • Understanding what happened to the old 87/91 LAL Guidance for Industry document
  • Learn what has replaced it and why
  • Learn of common issue misunderstandings and misinterpretations
  • Determine who comprised the agency guidance team involved with this new proposed guidance
  • Reviewing documents supporting this new guidance
  • Understand sampling, storage, handling and pooling
  • How does one transition from one bacterial endotoxin test to another?
  • Understand the Rabbit Pyrogen Test (RPT)
  • Learn about the Monocyte Activation Test (MAT)
  • Determine when the Rabbit Pyrogen Test is appropriate to use in lieu of the LAL
  • Understand the FDA’s expectation for screening of therapeutic products

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)

Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Course Title: Use and Application of Sanitizers, Disinfectants and Sterilants in a GMP Controlled and Classified Environment

  1. Regulatory Expectations of Sanitizers, Disinfectants and Sporicides
  2. Application of USP<1072> Disinfectants and Antiseptics
  3. Determining the Vendor Qualification Requirements
  4. Facility Requirements – Coupon and Suspension Studies
  5. The Impact of Sanitizers, Disinfectants and Sporicides on Various Common Microorganisms
  6. Developing an Application Schedule within Newly Commissioned, After Renovations, and Following Shutdown Facilities
  7. Monitoring and Interpretation of Results of the Cleaning and Disinfection Program
  8. A Review of Warning Letters
Day Two (8:30 AM – 4:30 PM)

Course Title: Revision of the FDA Endotoxin Test for Human Parentaeral Drugs, Biological Products and Medical Devices

  1. Learn about Current Testing Requirements
  2. What Happened to the 87/91 LAL Guidance for Industry Document
  3. Gain an Understanding of the FDA’s Recent Questions and Answers Document
  4. Learn More about Typical Issues Confronting the End User of LAL Testing
  5. How Does One Transition from One Bacterial Endotoxin Test (BET) to Another
  6. Understand the Rabbit Pyrogen Test (RPT) and When It Will Be Discontinued
  7. Understand the Regulatory Expectations for Screening of Therapeutic Products
  8. A Review of Warning Letters

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 Online

Register Online

Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-1-888-771-6965 or email at

Group Registrations

Send Your Team for Maximum Benefit Get your team up to speed!

Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

  • 2 Attendees
  • 3 to 6 Attendees
  • 7 to 10 Attendees
  • 10+ Attendees
  • -
  • -
  • -
  • -
  • Get 10% off
  • Get 20% off
  • Get 25% off
  • Get 30% off
Call Toll Free +1-1-888-771-6965 if you have any queries.

Register by Wire Transfer

If you wish to pay by wire transfer: Please call us at
Toll Free +1-1-888-771-6965

Download Registration Form

Yes, I want to attend "Application of Disinfectants and Sterilants to Control Microorganisms; FDA Endotoxin Test – Understanding the Latest Revision: 2-Day In-Person Seminar"
Click here to Download Registration Form
If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
2600 E. Bayshore Road
Palo Alto, CA 94303

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 @ +1-888-771-6965 or email us @


Payment is required before 2 days of 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 from 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 GRC Seminars 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 GRC Seminars cancels the seminar, GRC Seminars 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 before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:

By registering and attending GRC Seminars conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by GRC Seminars for marketing, archiving or any other conference related activities. You agree to release GRC Seminars for any kind of claims arising out of copyright or privacy violations.

Media Partners

If you wish to partner with us for this event please contact us: or call us: +1-888-771-6965.
Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.
Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.


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

Local Attractions

South Beach
South Beach is the most popular tourist attractions in Miami Florida located at east of Miami city, proper between Biscayne Bay and the Atlantic Ocean. The beach is the ideal place for a breath of fresh air beach style. It is perfect place for sunbathing, shopping or just watching people passing by on the beach.When the sun sets on South Beach, daytime shoppers become nighttime club-hoppers at a diverse array of nightspots.

Miami Seaquarium
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
Zoo Miami is the largest and oldest zoological garden in Florida, and the only tropical zoo in the United States. It houses over 2,000 animals on 740 acres (299 ha), 324 acres (131 ha) of which are developed.
Miami Science Museum
The Miami Science Museum is a great learning place. The museum itself also contains the Space-Transit Planetarium, Weintraub Observatory and a wildlife center. Those interested in galaxies, stars, planets and the intricate workings of the universe can quench their thirst for knowledge here.

Coral Castle
Coral Castle 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 (mostly limestone formed from coral), each weighing several tons. It currently serves as a privately-operated tourist attraction. Coral Castle is noted for legends surrounding its creation that claim it was built single-handedly by Leedskalnin using magnetism and/or supernatural abilities.

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 recreation, it is best known for its miles of off-road bicycling trails, ranging from novice trails to more than 10 miles challenging trails for experienced mountain bikers.