Microbiological Observations and Their Use within Warning Letters
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>
Available Live On-Demand
Microbiological Observations within Warning Letters have held steady within the top most frequent fifteen Citations that the FDA records within their Warning Letters on an annual basis. These citations may be found within the Code of Federal Register (CFR) within 21 CFR 211.113 (a)(b), as well as CFRs 211.84, 87, 165, 192, and still other sections of the CFR. They relate to and involve in-coming components, Active Pharmaceutical Ingredients (API) and non-sterile and sterile final products. Recently with heightened interest in in-coming components (raw materials), Citations are occurring within this area. Citations may also be given because of missteps of personnel, within the environment and the facilities.
Many of these Citations are not new, but those that reoccur year after year. Often these Citations not only become a blemish on a Company’s regulatory record, but also impact them financially. One of the most noticeable elements is Import Alerts that not only prohibits a Company from selling a product within the United States, but also may create a “drug shortage”. On a lesser known note, a Warning Letter may prohibit a Company or a Contract Manufacturing Organization (CMO) from gaining approval of a new drug through a Pre-Approval Inspection (PAI) since the terminology in the Warning Letter that states “may withhold approval” really should be interpreted as “will”.
The use of Warning Letters can serve as a significant opportunity to train individuals regarding the requirements set for various CFR microbiological areas. The FDA’s Warning Letters provide a “roadmap” as to those areas where Companies should first “look” for microbiological as well as other non-compliance issues that should be included within their own internal audits.
This live Pharmawebinar will review various areas of microbiological Warning Letters to include those related to components, Active Pharmaceutical Ingredients (API), non-sterile products, sterile products and miscellaneous areas. In addition, Warning Letters related to endotoxin will also be highlighted. This webinar, because of its content, is designed for attendance by interdisciplinary functions within your Company.
- An Overview of the most frequent Microbiological Citations from the Code of Federal Regulations (CFR) - Learn where many of the various Citations reside within your Facility CFR - Observe typical Citations based upon a Product’s and Facility Status - Understand why Endotoxin cannot be eliminated from Consideration
Webinar outline and time breakdown:
|12:45 PM||Log In Period|
|Overview of “Most Frequent Citations” for Past Several Years from the CFR,|
|Discuss the USP and Guidances for Industry pertinent to supporting the Citations,|
|Learn where potential Citations exist within your Facilities,|
|02:10 PM||Observe typical Citations based upon a Product’s, Personnel, Environment and Facility Status,|
|Understand why the presence of Endotoxin may create Citations,|
|How to use Warning Letters to anticipate Inspectional Priorities,|
|Review of current Warning Letters,|
|03:00 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 training for attendee 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
- Auditing Professionals
- Incoming Materials and Receiving
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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>>>