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Validation of Biotechnology-Related Cleaning Processes - August

Aug 22 - Aug 24, 2018 |
Aug 24, 2018 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Duration: 3 days
Time: 8:30 a.m. - 4:00 p.m.

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 clean-in-place (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.

Topics to be addressed include:

  • 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

Who Should Attend

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

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

Member

On or Before July 6, 2018
$3,386

After July 6, 2018
$3,773

Nonmember

On or Before July 6, 2018
$4,075

After July 6, 2018
$4,528


Government/Health Authority/Academic

$2,264

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by July 20, 2018, 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.

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

Rebecca Brewer, Vice President, Strategic Practices, Quality Executive Partners

Rebecca Brewer has more than 29 years of experience in validation and compliance within the pharmaceutical, biopharmaceutical and medical device industries. She began work with Quality Executive Partners, a boutique consultancy, to make a difference in pharmaceutical consulting in 2013.

Prior to working with Quality Executive Partners, Becky was Director of Consultancy and GMP Compliance with Dober, where she assisted customers with challenging validation and compliance problems, including cleaning validation. Prior to working with 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 cleaning validation and cleaning compliance programs for a large variety of companies and products. Becky’s work has led to the development of procedures and policies in some of the most challenging environments, including: research and development, contract manufacturers and suppliers. In addition to teaching PDA’s Validation of Biotechnology-Related Cleaning Processes course, Becky is the instructor for ISPE’s Cleaning Validation and Clean-In-Place courses. She also frequently conducts site-specific validation and GMP compliance training for individual companies. Prior to joining Raytheon, Becky worked for Bristol-Myers Squibb in New Brunswick, New Jersey. Becky has specific expertise in cleanroom design and construction, aseptic processing, isolation technology, computer system validation, cleaning and sterilization.

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 #575 | ACPE #0116-0000-17-030-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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