Hosted by the leader in the Federal Regulations and Guidelines Handbooks

GMP Publications, Inc.
&
The Auditing Group, Inc.

What You Will Learn:

• Status of Part 11 and Annex 11
• New requirements - FDA Perspective
• Major differences between the new interpretations and the old versions
• Risk-based validation justification details
• Leveraging vendor efforts, documentation and services
• The challenges in managing electronic records
• Recent FDA warning letters related to computer systems and e-records
• What inspectors will look for around IT compliance and electronic records
• Recommendations for compliance implementation
 

Good Validation Practice (GVP) - A Step by Step Approach Featuring In-Depth Presentations, Case-Studies & Workshops on:

Regulatory Expectations
Perspective from the FDA: 21 CFR Part 11 Compliance and Computer Validation
Determine Which Systems Need to be Validated
Software Validation Requirements for:
Spreadsheets
Production Equipment
Lab Equipment
Data Migration
User Requirement Specifications (URS)

*All courses include;

• Air and land transportation - Offer is good for US Citizens only. For attendees residing from outside the continental US, please add $1,000.00 USD.

• Hotel stay for 4 nights -

• All land transportation -

• Course Material Binders for each attendee with Certificate of completion

• Mini-Regulation Handbooks for each attendee specific to training course

“John has enjoyed over 26 years of hands-on technical and management level experience within the Pharmaceutical, Biotechnology, Medical Device, Petrochemical, Validation, and regulated industries world wide.

Serving within various business units within Quality Assurance / Regulatory Affairs, Training and Development, Manufacturing, Research, Engineering, Technical Mechanical Departments, etc.., John has assisted many companies in meeting and exceeding regulatory compliance, pertaining to ‘for-cause’ or ‘due-diligence’ initiatives. Assisting companies to achieve, resolve, remediate and exceed regulated industry requirements, mandates, ‘for-cause’ and ‘due-diligence’ priorities with the technique of promoting GxP standards and practices through interactive hands-on training.

John has extensive knowledge in industry standards; FDA, cGMP, GLP, ICH, OECD, GAMP, ISO, OECD, OSHA, HACCP, HIPPA, EPA and GCP regulations and thorough knowledge in the process of implementation of these standards.

John also enjoys speaking and engaging with and at many of the Industry professional associations, seminars, and trade shows world wide, conducted both on-site and off-site training seminars, and speaking engagements.”