Auditing and Validation Services for FDA Regulated Industry

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Upcoming Webinars

GMP QMSs from the Auditor's Perspective - Basic 100
An 8-hour 1-day webinar discussing the basic GMPs required to satisfy the annual requirement for GMP Training. Click here for more details.

Introduction to the QMS from the Auditor's Perspective

This aggressive Webinar focuses on the QMS Requirements that Auditors expect and challenges for compliance. The course is a basic general overview of the various components, i.e.

  • cGMP Basics including 21 CFR Part 11
  • CAPA,
  • Non-Conformance
  • Out of Specifications / Out of Trending
  • Change Control
  • Deviations
  • Complaints
  • Risk Management
  • Audit Management
  • Good Documentation Practice
  • Product Recall and Traceability
  • Training
  • Vendor Qualifications
  • 21 CFR Part 11 Electronic Systems
  • ...more

All attendees will receive (one week prior):

$295.00 per seat. Discounts are available!

 

November 10 - 11, 2020

10:00am - 6:00pm EST

$995.00

GMPs for Pharmaceutical "GMPs from the Auditor's Perspective.
This 2-day 16 hour webinar focusing on Drug Industry GMP requirement. This basic course outlines the requirements and the real world GMPs with the Auditor's real world situations and observations. Applicability is critical with discussions on actual findings.
Includes additional relevent references to the ICH Q7 API GMPs which correlates othe US Federal Regulations.

GMP Boot Camp Novermber Drug and Device Webinar Conference

 All attendees will receive (one week prior):

Register for Webinar

Discounts available for multiple seats - Click Here for more information

November 13 - 14, 2020

10:00am - 6:00pm EST

$995.00

GMP for Medical Device - "GMPs from the Auditor's Perspective".
This 2-Day 16-hour webinar taught by Medical Device industry Subject Matter Experts, with focus on 21 CFR Part 820 Quality Systems Regulations for the Regulated industry.

The course focuses on the requirements to meet internal, agency and customer's expectations for compliance.

Includes corellations to ISO 13485 Quality Management System.

 

 

 GMP Boot Camp Novermber Drug and Device Webinar Conference

 All attendees will receive (one week prior):

Register for Webinar

Good Auditing Practice Practices and Concepts 101
This 8-hour webinar focuses on the basics of ‘how to’ conduct on-site audits supporting the regulated industry under Title 21. If you manufacturer Biopharmaceuticals, Medical Devices, Dietary Supplements or other regulated products or services, the concepts and techniques are a valuable way to prepare for your next audit, whether you are performing or undergoing an audit. Explores the Auditing process from the perspective of the Auditor and the Auditee.

Conducted by John Cuspilich, Sr. Auditor for The Auditing Group, a division of GXP Services and GMP Publications, the world’s leading supplier of the Federal Regulations.

 All attendees will receive (one week prior):

Register

 

$295.00

Dietary Supplement GMPs 101 - The 4 hour basic overview of the Dietary GMPs in accordance with 21 CFR Part 111. Includes the basic requirements under the Predicate Rules including 21 CFR Part 11 Electronic Records; Electronic Signatures.

 All attendees will receive (one week prior):

Register

 

$495.00

GMP QMSs from the Auditor's Perspective - Basic 100
An 8-hour 1-day webinar discussing the basic GMPs required to satisfy the annual requirement for GMP Training. This basic course works through each part of the regulations 21 CFR Part 210/211 Drug GMPs.
Includes a 2 hour basic GMP overview and 6 hours of Parts descriptions with samples of applicability.

 All attendees will receive (one week prior):

Register

Introduction to the QMS from the Auditor's Perspective

This aggressive Webinar focuses on the QMS Requirements that Auditors expect and challenges for compliance. The course is a basic general overview of the various components, i.e.

  • cGMP Basics including 21 CFR Part 11
  • CAPA,
  • Non-Conformance
  • Out of Specifications / Out of Trending
  • Change Control
  • Deviations
  • Complaints
  • Risk Management
  • Audit Management
  • Good Documentation Practice
  • Product Recall and Traceability
  • Training
  • Vendor Qualifications
  • 21 CFR Part 11 Electronic Systems
  • ...more

The objective is to ensure that Attendees understand the Auditor's rationale, notable observations and risks pertaining to QMS failures.

 All attendees will receive (one week prior):

Register
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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