Skip To The Main Content
Parenteral Drug Association Connecting People, Science and Regulation ®

Fundamentals of Cleaning and Disinfectant Programs for Aseptic Manufacturing Facilities

Aug 02 - Aug 03, 2017 |
Aug 03, 2017 |
PDA Training and Research Institute | Bethesda, MD
  • Education
Add event to: ICal Outlook Google Calendar
Duration: 2 Days
Time: 8:30 a.m. - 4:00 p.m.

Controlling contamination in GMP classified areas requires much more than cleaning and disinfection. Operations need to assure that a complete system of control that starts with entry of components and personnel to the facility is established. This course will identify and describe systematic elements essential to assuring an appropriate and compliant contamination control program for aseptic manufacturing facilities, classified and non-classified environments. This course will also highlight the important aspects of PDA Technical Report No. 70, (TR 70) Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities.

The course covers the critical steps to developing and validating a complete contamination control program within controlled and non-controlled environments using chemical agents that reduce or destroy microorganisms. While sterile product manufacturing requires the most stringent application, the concepts introduced during the course can also be used to design a program for the manufacture of non-sterile products.

Topics to be addressed include:
  • Sanitizers, disinfectants, sporicides
  • Regulatory guidance
  • Qualification of new vendors and agents
  • Control of the environment
  • AOAC protocol testing for disinfectant registration
  • In-use expiration dating
  • In-situ field studies
  • Sterility of solutions and cleaning agents
  • Cleaning and disinfection
  • Frequency for cleaning and disinfection
  • Resistance and rotation
  • Return from a shutdown
  • Hold times for cleaning areas, non-product contact equipment and utensils
  • Training

Who Should Attend:

  • Quality Assurance: Managers, Supervisors, Technicians, Microbiologists
  • Quality Control: Managers, Supervisors, Technicians, Microbiologists
  • Validation: Managers, Supervisors, Engineers, Specialists
  • Manufacturing: Managers, Supervisors

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

  • Describe current contamination control principles as they relate to the cleanliness and sterility of product contact and non-product contact surfaces
  • Formulate in-house environmental control concepts to reduce bio-burden in operations
  • Analyze current regulations, guidance and industry standards as they relate to contamination control
  • Generate appropriate cleaning and disinfection procedures for controlled environments
  • Develop validation protocols for appropriate implementation of cleaning systems and chemical agents
  • Build risk assessment models
  • Conduct antimicrobial effectiveness testing and in-situ field studies at your facility
  • Select appropriate agents and develop cleaning frequencies
  • Formulate appropriate cleaning techniques for varying surfaces
  • Train personnel in appropriate methods of cleaning and disinfection

Standard

Member

On or Before June 19, 2017
$2,419

After June 19, 2017
$2,699

Nonmember

On or Before June 19, 2017
$2,915

After June 19, 2017
$3,239


Government/Health Authority/Academic

$1,619

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by July 3, 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

Art Vellutato, Jr., President and CEO, Veltek Associates, 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 #247 | ACPE #0116-0000-16-034-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.

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=3477

Directions