Global Event Calendar and Registration

Validation of Biotechnology-related Cleaning Processes

Apr 27 - Apr 29, 2015 |
Apr 29, 2015 |
PDA Training and Research Institute | Bethesda, MD
  • GSA Schedule
  • Training Course
Add event to: ICal Outlook Google Calendar

Duration: 3 days
Time: 8:30 a.m. - 4:00 p.m.

Speaker Biographies

This course is a biotechnology modification of the general laboratory cleaning validation course. It includes the lab elements of the standard course modified to focus specifically on issues for biotechnology manufacture. The lecture elements of the course will review all sections of PDA Technical Report #49, Points to Consider for Biotechnology Cleaning Validation.

This course is ideal for anyone involved in cleaning validation for biotechnology manufacture. This course provides attendees with a complete, hands-on cleaning validation education program covering both automated (CIP) and manual cleaning for biotech manufacture.

This three-day course includes the use of a CIP skid, which helps the attendees understand everything from the impact of system design on cleanability to how to take swab samples and set acceptance criteria. Participants will gain direct experience setting up an effective cleaning program by going through a systematic approach to cleaning validation. The approach used includes 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.

Extensive use of wet labs will help to emphasize the principles learned in the lecture material. These labs demonstrate the application of current cleaning principles to modern pharmaceutical equipment. Use of riboflavin for spray ball coverage testing, as well as swabbing techniques for surface analysis, will be demonstrated. Each student will determine his or her own swab recovery percentage with sampling coupons. The different elements of the hands-on aspect of the course include: spray ball coverage testing (riboflavin), 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 and CIP process validation.

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
At the 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 13, 2015 $3,250 $3,595 $2,000 $2,100
Price after March 13, 2015 $3,595 $3,895 $2,000 $2,100

All rates in US Dollars

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.

Location

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

PDA Training and Research Institute
4350 East West Highway, Suite 150
Bethesda, MD 20814

Recommended Hotel

Hilton Garden Inn Bethesda

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

* Must use the code N0033113 when making your reservation via phone. Rates are subject to availability.
Reservations

Contact

For more information, please contact:

James Wamsley
Senior Manager, Laboratory Education
Tel: +1 (301) 656-5900 ext. 137
Email: wamsley@pda.org

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.

ACPEThe PDA Training and Research Institute 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

Coming Soon

Related Events

    Downloads

    Exhibitors Toolkit

    Please read: PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.