USP <1115> Bioburden Control of Non-Sterile Drug Substances and Products– A New USP General Information Chapter

Live, Interactive Training Webinar

Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>

Schedule & Deliver this Live Training Webinar Privately to Your Group

USP recently released a new document describing bioburden control of non-sterile drug substances and products -- a much anticipated area that has gained significant attention over the past half dozen years. The subject, "USP <1115> Bioburden Control of Nonsterile Drug Substances and Products", has generated much controversy as nonsterile manufacturers have repeatedly asked the question "what degree of microbial cleanliness should I require with my nonsterile drug substances and products" and "how many microorganisms of a single genus may I have where USP<1111> has limits of either 100 or 1000 per gram"? Efforts have been made to historically determine these questions within other USP Chapters to include USP<61>, USP<1111> and USP<1231> which have addressed both test methodologies and microbial counts allowed. 21 CFR 211 has also "weighed into" this fray with their various regulations, but have not offered solutions. Quite often during lectures and seminars, the comment is overheard "With sterile products, it was so much simpler to provide a microbial answer because I have definitive endpoints".

This new USP General Information Chapter approaches nonsterile drug substance and bioburden control from a Risk Management perspective (ICH Q9). It compares considerations of excessive cost and complexity vs. added value to the consumer and the product. The document also provides microbial control considerations in an array of microbiological control areas to include manufacturing, equipment design, personnel and the overall management of a nonsterile microbiological control program.

The objective of this live, PharmaWebinar is to review this new document and consider how a risk-based approach to the control of potential contamination in nonsterile product manufacturing may assist your organization. Plan to bring a multi-functional group to this webinar to gain the most from this new USP General Information Chapter.

Learning Benefits:
-Overall Management of a Microbiological Control Program.
-Microbial Assessment of Nonsterile Product Manufacturing Environments.
-Microbial Control Considerations During Product Development.
-Microbial Control Considerations During Manufacturing.
-Microbial Control of Drug Substance Manufacturing.

Webinar outline and time breakdown:

10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions,
Overall Management of a Microbiological Control Program,
Microbial Assessment of Nonsterile Product Manufacturing Environments,
Microbial Control Considerations During Product Development,
11:30 AM Break
11:40 AM Examine the Bases for the Bacterial Endotoxin Tests,
Microbial Control Considerations During Manufacturing,
Microbial Control of Drug Substance Manufacturing,
Warning Letter Examples,
12:30 PM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of participation for attendee training records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Quality Assurance personnel
  • Quality Control personnel
  • Research & Development
  • Regulatory Affairs Professionals
  • Validation
  • Auditors

Schedule & Deliver this Live Training Webinar Privately to Your Group

Instructor: Barry A. Friedman Ph.D.

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... Full Bio>>>



Course Number: 220

System Requirements:

All Pharma Webinars live training programs audio and visual are delivered via Cisco WebEx with basic system requirements of a computer with internet access and a telephone to access the audio portion of the presentations. You can choose to access the audio through your computer.

Live Training Benefits:

• Pharma Webinars training webinars and programs are presented exclusively as live events only.

• Designed and delivered based on e-learning best practices, Pharma Webinars' live training webinars and programs are as effective as in person training.

• Live training webinars and multi-part training programs are strictly educational based, and do not promote or endorse any products or services whatsoever.

• An interactive live Q&A and discussion period is included in each live training presentation. Questions can also be submitted to the speaker via email both prior to and following the live training webinar as a means of improving participant experience, and ensuring successful topic comprehension.

• Live presentations ensure that all live training webinars and programs are engaging and informative, allowing trainees to exchange ideas through audio conferencing and live chat during each presentation in real time. Each live training session includes a dedicated live Q&A period allowing trainees to interact directly with the instructor, with quick feedback providing them with concrete understanding of the answers and the training subject itself.

• Each Pharma Webinars live training webinar and program content is updated on regular basis to provide the latest regulatory, operational and technological trends in the international pharmaceutical arena. As regulatory expectations, guidance, or industry trends change, so does our training in order to reflect those changes as soon as the changes are released.

• Pharma Webinars' instructors are the most recognized subject matter experts in the industry who are selected based on very strict qualification criteria. They are coached on the latest e-learning speaking methods in order to make each presentation engaging, memorable and very effective.

• Each registered attendee receives an exact copy of the presentation slides and other course handouts significantly reducing the learning curve as trainees can refer back to this material in the future.

• All trainees receive a Certificate of Attendance for each live training webinar and program they attend to be kept for training records.

Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland