Process Validation for FDA Regulated Industries

Size: px
Start display at page:

Download "Process Validation for FDA Regulated Industries"

Transcription

1 Microrite, Inc. brings you this unique learning experience in Process Validation for FDA Regulated Industries; Part of Microrite s step-by-step webinar series. Process Validation for FDA Regulated Industries Effective process validation provides confidence in drug quality. The basic principle of quality assurance is that a drug should be fit for its intended use. This principle incorporates the understanding that quality, safety, and efficacy are designed or built into the product. Since quality cannot be adequately assured merely by in-process and finished-product inspection or testing, a validated process provides additional assurance. When? September 11 th, :30pm to 3:30pm Eastern Standard Time Which industries does this webinar apply to? Pharmaceuticals, Biotechnology, Cosmetics, Medical Devices, and In Vitro Diagnostics Who will benefit? Quality Assurance, Manufacturing, Validation, Engineering, Project Management, and Training Personnel

2 September 11 th, 2014 Benefits to the participants: Understand requirements & expectations of Process Validation (PV) The roles of QA, QC, Validation and Production personnel in PV PV Protocol - how to develop and what needs to be included How to execute PV protocol How to write deviations (protocol and product deviations) Summary Reports - how to develop and what needs to be included How to monitor process validation Who will be teaching? M. M. Chowdhury, ChE., PMP is an experienced Quality Assurance/ Validation Project Manager & Consultant/ Engineering & Validation Manager with over fourteen (14) years in the USA Pharmaceuticals, Medical & Biotech Industries. He managed and performed multiple equipment/system, utilities, facilities, computer, process and cleaning validation activities; and overseen Change Control, CAPA, Deviations, Calibration and Maintenance Programs, coordinated multiple USFDA and other regulators inspections. He also have worked in the areas of Validation Project Management, Remediation Projects, GMP Production Supports, QA, Global Outsourcing, Change Control System, GxP Compliance, Engineering, Technical Supports (Deviations, Investigations & CAPAs), Manufacturing, Technology Transfer/Scale Up, Supplier/Vendors/Contract Manufacturers/QA Audits and Quality Control. He has been an employee and consultant for multiple world-class USA pharmaceutical companies including Pfizer, Aventis-Sanofi, Johnson & Johnson, Dow Chemical, Élan Pharmaceuticals, CB Fleet Lab, AVI BioPharma and Cody Laboratories. Currently he supports Sanofi Pharmaceuticals as Quality & Validation Project Manager in Georgia, USA.

3 REGISTRATION FORM Process Validation for FDA Regulated Industries Personal Information of One Registrant Last Name: Mr. Ms. Dr. First Name: Job Title: Organization: Mailing Address: Telephone: Fee: (see fee structure below, all costs are per attendee) 1 attendee $ attendees $180 (per attendee)(20% Discount) 6-10 attendees $153 (per attendee)(32% Discount) 11 or more attendees $135 (per attendee)(40% Discount) Method of Payment: Credit Card and Check payments only. Attendees can register and make payments on Microrite s website: or complete this form and fax to Check payments must be cleared before the webinar date. If you have any questions regarding payment methods feel free to contact Microrite at or send your enquiry to webinars@microrite.com. Confirmation of registration will be sent via . For credit card payment on website, a payment receipt will be considered as confirmation of registration. For credit card information faxed to Microrite an confirmation will be sent with a copy of payment receipt. Please call in due time if confirmation is not received after payment. Webinar cancellation must be received 3 business days prior to the webinar less a 10% service fee, cancellation requests will be accepted via only. All refund requests must be made by the organizations primary contact or credit card holder. Refunds will be credited to the original credit card used to purchase the webinar.

4 Additional Attendees First and Last Name

5 Choose One (Place X) VISA Master Card American Express Card Holder s Name Address of Card Holder: Enter firm address for corporate card or personal address for personal card Street: City/State: Zip Code: Country: Contact Ph No & Card Number: Expiration(Month/Year): Amount (US Dollars): Signature: Name of Attendee(s) Referred by: Kindly note the name of the company or person that referred you to this workshop. We would like to thank them.