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Parenteral Drug Association Connecting People, Science and Regulation ®

Mold Identification for Quality Control

Apr 08 - Apr 09, 2019 |
Apr 09, 2019 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Duration: 2 days
Time: 8:30 a.m. - 4:00 p.m.

Microbial identification is a critical step for any Quality Control (QC) microbiology laboratory. Regulatory requirements demand identification of objectionable microbes including mold. A growing challenge for Pharmaceutical QC is performing mold identification from products, raw materials and the manufacturing environment.

This interactive course will give participants an opportunity to identify environmental isolates of mold using both macroscopic and microscopic techniques. Hands-on exercises will include Genus and species identification for many common, environmental mold contaminants that can be found in routine testing. This course will also include risk assessment for mold contamination, methods used to avoid mold contamination, preservation of mold specimens, rapid methods and SOPs for mold identification. Participants will be given an opportunity to record observations of the morphology of numerous species growing on several types of media. Participants will receive a free copy of the book, “Medical Mycology: A Self-Instructional Text,” by Martha E. Kern, as well as copies of photomicrographs of common environmental molds.

Who Should Attend

This course is intended for for professionals who are responsible for the identification of mold contaminants of finished product, raw materials or the manufacturing environment. Typical areas and roles include the following:

  • Quality Control: Microbiologists, Supervisors
  • Quality Assurance: Specialists, Supervisors

Participants should have a basic understanding of microbiology.

Upon completion of this course, you will be able to:

  • Identify common environmental isolates of molds to the Genus level and, for some isolates, to the species level
  • Recognize proper terminologies for both macroscopic and microscopic images of molds
  • Recommend isolation techniques appropriate for identification of mold
  • Use several different techniques to identify unknown mold isolates
  • Locate potential sources of mold contamination and determine how to eliminate the source
  • Design an in-house mold culture collection system
  • Prepare an SOP specific for identification of molds
  • Discuss the pros and cons for rapid methods of identification of molds
  • Recognize appropriate reference books for mold identification
  • Train colleagues on the methods used for mold identification

Standard

Member

On or Before February 22, 2019
$2,519

After February 22, 2019
$2,799

Nonmember

On or Before February 22, 2019
$3,023

After February 22, 2019
$3,359


Government/Health Authority/Academic*

$1,679

*For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Accommodations and Dietary Requirements
If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact registration@pda.org or +1 (301) 656-5900. SUBSTITUTION: If a substitution request is sent by March 9, 2019, no fee will be charged. After March 9, 2019, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee. REFUND: If a refund request is sent by March 9, 2019, a full refund will be given minus a $200 fee. After March 9, 2019, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

General Course Information

Please arrive at the course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.

Location

The course will be held at:

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 110
Bethesda, MD 20814 USA

Recommended Hotel

Hilton Garden Inn Bethesda
7301 Waverly Street | Bethesda, MD 20814 | 0.3 miles from PDA
(301) 654-8111

Contact

For more information, please contact:

Kimberly McIntire
Manager, Education
Tel: +1 (301) 656-5900 x103
Email: mcintire@pda.org

John Brecker, Consultant for Microbiology

John Brecker has been teaching the Mold and Yeast Identification at PDA since 2001. Mr. Brecker is certified as a Registered Microbiologist, Consumer Products and Quality Assurance, through the American Academy of Microbiology, National Registry of Microbiologists. He has spent over forty years as a Quality Control Microbiologist for the pharmaceutical, biopharmaceutical and personal care product manufactures.

His expertise includes microbial identifications, microbiological testing and validations, environmental monitoring, as well as research and development. His responsibilities as a QC Microbiologist included the identification of fungi using visual examination and rapid methods. Mr. Brecker received his BS in Biology from St. Joseph’s University. As a member of the TAPPI Microbiology and Microbial Technology Committee, he has contributed a chapter in a Monograph on Microbiology of Papermaking Systems (2008). Mr. Brecker has also published a technical paper on the use of fungi for the treatment of wood pulp to make paper. In April 2005, John received the James P. Agalloco Award for excellence in education in recognition of his outstanding performance on the PDA faculty.

Continuing Education for Pharmacists

ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

PDA #803 | ACPE #0116-0000-17-002-L04-P | 1.2 CEUs
Type of Activity: Application

Continuing Education for Professional Engineers

New Jersey

PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

The credit value of this course is 12 CPC credits.

North Carolina

PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

The credit value of this course is 12 PDHs.

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