Understanding GxP (GMP, GCP & GLP) for FDA Regulated Industries

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Verity Harvey
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Microrite, Inc. brings you this unique learning experience in Understanding GxP (GMP, GCP & GLP) for FDA Regulated Industries; Part of Microrite s step-by-step webinar series.

1 Microrite, Inc. brings you this unique learning experience in Understanding GxP (GMP, GCP & GLP) for FDA Regulated Industries; Part of Microrite s step-by-step webinar series. Understanding GxP (GMP, GCP & GLP) for FDA Regulated Industries FDA GxP standards are constantly shifting. Your company s GxP compliance systems must be able to meet this challenge proactively to prevent any disciplinary actions that may be imposed by the FDA due to non-compliance, which can result in delayed premarket approval or product recalls in the worst case scenario. GxP compliance must be able to account for an appropriate level of risk management as well as establish policies and procedures. When? October 16 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, Quality Control, Microbiology, Facilities, Manufacturing, Validation, Engineering, Project Management, and Training Personnel

2 October 16 th, 2014 Benefits to the participants: What is GxP and why it is important Good Manufacturing Practices (GMP) Regulations & expectations Good Laboratories Practices (GLP) Regulations & expectations Good Clinical Practices (GCP) Regulations & expectations How to implement cgmp How to implement GLP How to implement GCP Role of QA, QC, Manufacturing, and Validation in GxP 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 Understanding GxP (GMP, GCP & GLP) 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.

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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.

Filling and Packaging Validation for FDA Regulated Industries

Microrite, Inc. brings you this unique learning experience in Filling and Packaging Validation for FDA Regulated Industries; Part of Microrite s step-by-step webinar series. Filling and Packaging Validation