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Validation of Biotechnology-Related Cleaning Processes

Apr 19 - Apr 21, 2016 |
Apr 21, 2016 |
PDA Training and Research Institute | Bethesda, MD
  • GSA Schedule
  • Education
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Duration: 3 days
Time: 8:30 a.m. - 4:00 p.m.

If you are involved in cleaning validation for biotechnology manufacturing, then this course is for you!

Based on PDA Technical Report #49, Points to Consider for Biotechnology Cleaning Validation and taught by noted validation and compliance expert Rebecca Brewer, this course uses a combination of lecture and lab instruction to provide a complete, hands-on cleaning validation education program covering both automated (CIP) and manual cleaning for biotechnology manufacture.

A modification of the general laboratory cleaning validation course specifically for biotechnology, this three-day course includes the use of a CIP skid, which will help you understand everything from the impact of system design on cleanability to how to take swab samples and set acceptance criteria.

You'll gain direct experience setting up an effective cleaning program by going through a systematic approach to cleaning validation. Areas of focus include: initial evaluation of the equipment to be cleaned, analytical techniques, worst-case conditions, multi-product cleaning, cleaning cycle development and validation of the cleaning process.

The benefit of taking a course at PDA’s Training and Research Institute is the hands-on training in an actual lab facility. In this course, wet labs are used extensively to emphasize the principles learned during the lecture portion.

These labs demonstrate the application of current cleaning principles to modern pharmaceutical equipment, including spray ball coverage testing, and swabbing techniques for surface analysis. Each student will determine his or her own swab recovery percentage with sampling coupons.

Take advantage of hands-on, interactive learning related to:

  • Spray ball coverage testing Visual detection
  • Swab recovery
  • Cycle development
    • Cleaning agent concentration determination
    • Cycle development - CIP cycle exposure time determination
    • Cycle development - CIP cycle rinse time determination
  • Manual cleaning process validation
  • CIP process validation

Participants will receive a copy of Technical Report #49.

Who Should Attend

  • Manufacturing/Production - Managers/Supervisors and Technicians
  • Validation - Managers/Supervisors and Technicians
  • QA/QC - Directors, Managers/Supervisors and Technicians/Specialists
  • Engineering - Managers/Supervisors and Specialists

Key Topics

  • TR#49 Points to Consider for Biotechnology Cleaning Validation
  • Spray ball coverage testing
  • Swab recovery/analysis
  • Cleaning agent concentration determination
  • CIP cycle exposure time determination
  • Complete CIP cycle development
  • Manual cleaning procedure validation
  • Cleaning validation acceptance criteria

Take-Home Benefits

  • Learn about different cleaning methods to determine which is best for your facility
  • Determine cleaning validation acceptance criteria to comply with regulatory requirements
  • Prevent sampling errors to reduce contamination
  • Evaluate proper sampling techniques to save resources
  • Streamline swabbing recovery studies
Upon completion of this course, you will be able to:
  • Discuss the principles of cleaning and cleaning validation
  • Describe CIP system design and operation
  • Analyze cleaning engineering, physics and mechanics
  • Develop cleaning validation protocols for CIP systems and cleaning processes
  • Review testing methods used for cleaning process validation (surface and rinse analysis)
  • Determine the unique cleaning validation acceptance criteria for biotech manufacture
  • Discuss numerous cleaning validation tips, techniques and pitfalls
  Standard Government / Health Authority / Academic
  Member Nonmember Member Nonmember
Price on or before March 4, 2016 $3,250 $3,495 $2,000 $2,100
Price after March 4, 2016 $3,595 $3,895 $2,000 $2,100

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by March 21, 2016, 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 or +1 (301) 656-5900.

Class Schedule

All lab courses begin at 8:30 a.m. and end at 4:00 p.m. unless otherwise noted on the confirmation letter or in course information posted on the website or in the course brochures. Courses that are listed with a half day will begin at 8:30 a.m. and end at noon on the last day.

Please arrive at your course location approximately thirty minutes before the start of the course to register and receive your course materials. Please be sure to bring your confirmation letter as proof of registration during check-in. TRI 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 from 12:00 – 1:00 p.m. Snacks will be provided during the morning break from 10:00 – 10:15 a.m. and the afternoon break from 2:30 – 2:45 p.m.


The course will be held at the PDA Training and Research Institute:

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


For more information, please contact:

Kimberly McIntire
PDA Training and Research Institute
Assistant Manager, Laboratory Operations
Tel: +1 (301) 656-5900 x103

Rebecca Brewer, Director, Consultancy Services, Dober Group

Rebecca Brewer has more than 18 years experience in validation and compliance within the pharmaceutical, biopharmaceutical and medical device industries. She joined Dober Group as Director, Consultancy Services, Validation and GMP Compliance in order to provide Dober’s cleaning chemical customers with cleaning validation consultation and general compliance and validation assistance. Prior to joining Dober, Becky was a senior consultant with Raytheon Engineers & Constructors’ Validation Services Department (now Washington Group). As a consultant, Becky has had the opportunity to audit, develop and provide training in validation and compliance programs for a large variety of companies and products. Becky’s work in cleaning validation has led to the development of procedures and policies in some of the most challenging environments, including: potent compound facilities, isolation suites, research and development, contract manufacturers and suppliers. Prior to joining Raytheon, Becky worked for Bristol-Myers Squibb in New Brunswick, New Jersey where she participated in the development of their cleaning validation program, supervised the validation microbiology laboratory and conducted computer system validation, among other activities. Becky has specific expertise in cleanroom design and construction, aseptic processing, isolation technology, cleaning and sterilization.

ACPEPDA 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 #575 | ACPE #0116-0000-14-033-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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