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Essentials of USP Microbiology – Reading Between the Lines of the USP General and Information Microbiology Chapters

May 22

Location: Toronto, Canada

Microbiology plays a role throughout the manufacture of pharmaceutical products.  Whether the final product is non-sterile or sterile, the bioburden exists from the raw materials, throughout the process and/or within the product’s environment (water and HVAC) to the final product.  A critical review of the overall microbiological process will determine whether the critical “in-process” points permit the final product to meet its acceptance criteria.  In addition, any “objectionable” or “specified” microorganisms that may be encountered during the procurement of raw materials and the processing must be considered.

Whether you are testing a starting material (component), an in-process sample, the Active Pharmaceutical Ingredient (API), final product (whether non-sterile or sterile), the environment to include controlled and classified areas or the HVAC, you should be aware of the critical role the microorganisms play throughout.  You should be aware of the various microbiological related documents, e.g., raw material sampling criteria, in-process, API, final product, environmental and utilities, (many of which have USP microbiological documents as the “bedrock” for building these documents), to determine whether the SOPs, validations as well as government and other regulatory body document requirements are being maintained to assure the control required to permit the final product to enter the marketplace as safe.

The objective of this one day “Essentials of USP Microbiology” seminar is to explore USP General and General Information Chapters to learn which are available and to confirm that those that you are using are being used correctly.  Do not rely upon Health Canada or the FDA to become your Quality auditors.  USP documents that will be reviewed include USP <51>, <61>, <62>, <71>, <1072>, <1111>, <1112>, <1113>, <1116> and others.  Various team exercises will be conducted to allow the participants to use these USP documents to solve “real life” problems.  Plan to bring a cross-functional group of your personnel to attend this invaluable one day seminar.

Attendees Will Learn About

  • The various General and General Information USP chapters that apply to microbiology
  • The focus of the chapters to include those that primarily involve non-sterile and sterile applications
  • Chapters that involve the environment
  • Examining the changes within the various Chapters that have recently occurred and how to interpret them
  • Review areas that are often overlooked
  • Study issues that continue to exist between the USP, EP and JP
  • Examine the new regulatory attitude that is occurring with non-sterile products
  • What now constitutes a “specified” microorganism
  • Explore Form FDA 483’s and Warning Letters for microbiological applications

Dr. Barry A. Friedman, Ph.D., LLC

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance, Microbiology and Aseptic Processing arena. From 2000 to 2007, Dr. Friedman was associated with Cambrex Bio Science Baltimore, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, MD. In that capacity as the Director, 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 compliance interactions.

Dr. Friedman has over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness assistance, quality control, sterility assurance, microbiological/analytical validations and fermentation technology. In addition to the associations listed above, other associations have included Chesapeake Biological Laboratories, W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.

Dr. Friedman is a frequent seminar and webinar speaker and specializes in the areas of regulatory compliance, internal auditing, aseptic processing for sterile drug products, USP and Warning Letter “dissection”, multi-departmental interactions, 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, TungstenShield, IPA (Canada), Executive Conference Corp., Compliance OnLine, and Pharmig (UK). He maintains an active Blog (www.barryafriedmanphdllc.com/) that contains over 200 Blogs that address various Warning Letter and FDA 483 issues as well as over 1,500 “Search” terms.  He is a member of ASM, PDA and RAPs. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President and current Treasurer of the Capital Area Chapter, PDA. He recently received the James Agalloco award from PDA which is awarded to a PDA faculty member who exemplifies outstanding performance in education.

This unique one-day seminar is for professionals in the pharmaceutical, biopharmaceutical and life science industries with responsibilities in the following areas:

  • Manufacturing
  • Product Development
  • Project Management
  • Quality Assurance
  • Quality Control
  • Regulatory Affairs
  • Regulatory Compliance

Registration Fee & Discounts:

Early Bird: Till April 23, 2019

Regular Price: April 24, 2019 to May 22, 2019

$528 CAD + HST $628 CAD + HST

 

Academia / Government

At all time 

$388 CAD + HST

The fee is payable in advance and includes continental breakfast, lunch & refreshments, course material and certificate of attendance.


Group Registration Discount
Group Registration is available for all our live events. Please contact us: By email: enquiry@ipacanada.com or Call: 416-410-7402

Cancellation Policy
Cancellations received in writing more than 3 weeks before the event will be subject to a service charge of $150.00 CAD. The full conference fees remain payable if cancellations are received less than 3 weeks prior to the event. Substitutions are welcome at any time. It may be necessary for reasons beyond the control of the organizer to alter the timing of the program or the identity of the speakers. In the unfortunate event that an event is cancelled IPA are not liable for any costs incurred by delegates in connection with their attendance.

Course Venue 

AAPS
2960 Drew Road, Unit 140,
Mississauga L4T 0A5
Canada

Nearby Hotel Accommodation: 

Hilton Garden Inn Toronto/Brampton
2648 Steeles Avenue East, Brampton, Ontario, L6S6J9, Canada
TEL: +1-905-595-5151
Website: https://hiltongardeninn3.hilton.com
Driven Distance: 6 Mins

Four Points by Sheraton Toronto Airport
6257 Airport Road, Mississauga, Ontario L4V 1E4, Canada
Tel: 1 905-678-1400
Website: fourpoints.com/torontoairport
Driven Distance: 12 Mins

 

 

 

Details

Date:
May 22
Event Category:
Event Tags:
,

Venue

Toronto, Canada

Organizer

IPA
Phone:
(416) 410 7402
Email:
enquiry@ipacanada.com
Website:
http://ipacanada.com