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Parenteral Drug Association Connecting People, Science and Regulation ®

Process Validation: A Lifecycle Approach — Oral Solid Dosage/ Semisolid Dosage Forms Annex - New Course

Oct 29 - Oct 29, 2018 |
Oct 29, 2018 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Duration: 1 day
Time: 8:30 a.m. - 4:00 p.m.

The participant will learn how to employ process understanding and quality risk management principles to the three Process Validation concepts described below:

  • Stage 1: Process Design
  • Stage 2: Process Qualification
  • Stage 3: Continued (Ongoing) Process Verification (CPV)

In addition, the participant will learn how to apply Stage 3 CPV concepts to existing company/site legacy products.

Who Should Attend

Managers, directors and new or experienced professionals in process development, process validation, and quality assurance personnel will benefit in taking this course.

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

  • Describe the requirements for the development of of a new product using a Process Design Stage and apply the lessons learned to your workplace
  • Explain the requirements for the development of a new product using a Process Qualification Stage and apply the lessons learned to your workplace
  • Demonstrate the ability to respond to unexplained departures from established ranges with clear identification of impact including linkage to the firm’s quality systems
  • Develop a Stage 3 Continuous Process Validation program for legacy products which includes linkage to the firm’s quality systems

Standard

Member

On or before September 14, 2018
$1,192

After September 14, 2018
$1,325

Nonmember

On or before September 14, 2018
$1,431

After September 14, 2018
$1,590


Government/Health Authority/Academic

Member

$795

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by October 1, 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
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:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: ko@pda.org

José L. Toro, PhD, Principal Consultant, Lachman Consultants

José L. Toro, Ph.D. is a Principal Consultant in the Compliance Practice at Lachman Consultants who has extensive R&D Quality, and Quality Operations experience in the pharmaceutical industry. Dr. Toro specializes in the transformation of Quality and Technical Services organizations including Quality Systems, global implementations, corporate auditing, technology transfer and plant operations. He has a broad knowledge of regulatory compliance and quality control. Dr. Toro is well versed in FDA, MHRA, IMB, ANVISA; Japan and Korean inspections. He is highly experienced in manufacturing technologies for most dosage forms (aseptic processing, complex prefilled syringes, extended-release solids, liquids, semi-solids) parenterals, medical devices, combination products, as well as bulk operations. Dr. Toro co-authored the PDA Technical Report (TR 60-2) on Solid and Semi-solid Process Validation.

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 #540 | ACPE #0116-0000-18-012-L04-P | 0.6 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 6 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 6 PDHs.

Cancelled

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