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Validation of Moist Heat Sterilization Processes - May

May 31 - Jun 02, 2017 |
Jun 02, 2017 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Duration: 3 days
Time: 8:30 a.m. - 4:00 p.m.

This course provides hands-on training on the science of sterilization (microbiology and thermal science) with a validated steam autoclave and thermal validation equipment. Bring your challenges to the course and brainstorm possible solutions with the class and instructor while running actual loads.

Moist heat sterilization processes are considered to be "special processes" since the output of the process, product sterility, cannot be fully verified with test methodologies such as the sterility test. Therefore, it is absolutely essential that moist heat sterilization processes be properly designed, validated and controlled. This course will provide a foundational understanding of sterilization science that will then be applied in the selection of a cycle design approach, sterilization process development, process performance qualification and ongoing process control. The course is based on the latest revision of PDA's most popular sterilization reference, PDA Technical Report No. 1, Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control. Since its issuance, it has been widely utilized by industry and regulatory sterilization professionals in the development and assessment of sterilization programs across the globe.

The laboratory hands-on part of the class will include actual cycle execution with data review. During this section of the class the attendees will be encouraged to discuss challenges being faced or expected to be faced. The class will then participate in brainstorming over possible solutions. Based on the load items discussed, actual load runs will be executed, so that attendees can observe actual performance. If the attendee can bring an example of the load item, it will be integrated into the lab execution.

Who Should Attend

Manufacturing Operations, Formulation, Engineering, QA/QC, Product and Process Development, Regulatory Affairs, Research and Development, Sterility Assurance, Technical Operations and Validation Professionals.

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

  • Discuss microbiology and sterilization science and apply these concepts in the development of a scientifically sound and regulatory compliant sterilization program
  • Develop a decision tree to select the most appropriate sterilization process based on the attributes of the load type
  • Utilize the semi-log survivor curve equation in support of the development and ongoing control of the sterilization program
  • Assess risk associated with the cycle phases and identification of key and critical process parameters in the development of the sterilization process for liquid and porous/hard goods load types
  • List the critical elements of process performance qualification

Standard

Member

On or Before April 17, 2017
$3,319

After April 17, 2017
$3,699

Nonmember

On or Before April 17, 2017
$3,995

After April 17, 2017
$4,439


Government/Health Authority/Academic

$2,219

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by May 1, 2017, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

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.

A continental breakfast will be served before class beginning 8:00 a.m. Lunch will be provided between 12:00 - 1:00 p.m. Snacks will be provided during breaks throughout the day.

Location

The course will be held at:

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 150
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
Assistant Manager, Laboratory Operations
Tel: +1 (301) 656-5900 x103
Email: mcintire@pda.org

Deborah J Drew, President and CEO, Drew Quality Group, Inc.

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 #468 | ACPE #0116-0000-16-035-L04-P | 1.8 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 18 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 18 PDHs.

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