EXCiPACT and EXCiPACT Pharmaceutical Auxiliary Material are certifications that are under high demand. Please join our live webinar covering the ways that EXCiPACT adds value to suppliers and users of excipients. This webinar will cover how the EXCiPACT Scheme relates to GMP, GDP, GWP & PAM Standards, how suppliers can best prepare before audits, train their staff, what the audit will entail. We’ll also share some of the most common challenges and best practices to set your team up for success.
Objective
The objective of this webinar is to explain how EXCiPACT certification adds value to suppliers and users of excipients.
Agenda
- Introduction
- What is EXCiPACT?
- What are a Pharmaceutical Auxiliary Materials (PAM) Standards
- How does EXCiPACT apply to GMP, GDP, GWP & PAM
- Best practice to determine the GMP required for excipient suppliers
- The difference between a guide and a standard
- How EXCiPACT assures the quality of audits
- Who requires EXCiPACT Certification and which markets require it the most?
- How to use EXCiPACT Certificates & Audit Reports
- What does the Certification Process Include?
- What happens if there’s a non-conformance during the Stage 1 or Stage 2 Audit?
- What are the most common non-conformance items during an EXCiPACT Audit?
- How to best prepare for an EXCiPACT Audit?
- Pre-Audit, Training, Internal Audit, etc.
- Q&A
Target Audience: This webinar is aimed at Quality Assurance and Regulatory & Compliance Teams.
Language: English
Cost: No Charge
Can't make a live session? Register now and receive a complimentary recording after the live event.
Speakers:
Iain Moore
Senior Advisor, EXCiPACT
Iain Moore was project leader for the development and delivery of the EXCiPACT Certification Scheme, and stood as its first President, He is also chair of the EFfCI - The European Federation for Cosmetic Ingredients GMP Committee which oversees the EFfCI GMP Guide and standard for cosmetic Ingredients. Iain Moore was Global Head of Quality Assurance Croda Europe Ltd in the United Kingdom. He worked for Croda for 36 years, and for more than 25 years in various quality roles, including overseeing two UK regulatory inspections. He has contributed to the publication of European and US National Standards as well as many IPEC Europe - European Excipients Association Guides. And today he has taken on the role of Senior Advisor for EXCiPACT.
Jon Gawlak
Technical Manager/Senior Auditor, SGS North America
Over 30 years of Quality and Project Management Experience with over 25 years of Leadership Experience in the Pharmaceutical, Cosmetic, Personal Care, Food, and Medical Device Industry
Specialties: QA, QC, Supplier Qualification and Management, CMC, Quality Management, Project Management, Certification Auditing, Vendor Auditing, Internal Auditing, Analytical Testing, QC Laboratory Management
John Armstrong
Regional Sales Manager, Pharmaceuticals, SGS North America Inc.
John has over twenty years of experience in the healthcare industry holding senior leadership roles in commercial operations, sales and sales training with a focus on biopharmaceuticals, medical devices and OTC skin care products.
Currently, John is a Regional Sales Manager at SGS covering the Eastern USA for Pharmaceutical Products.
For further information, please contact:
Dominic James
Marketing Assistant
t: +1-862-339-6737