Regulatory cGMP Inspections Course Overview

GMP-compliance is a must for manufacturers of finished pharmaceutical products and active pharmaceutical ingredients (APIs) according to the different national legislations. The related GMP rules are typically valid for one country based upon the anchoring in the respective national laws. However, at the same time the GMP rules are more or less internationally harmonized such as e.g. the ICH Q7 Guidelines representing the “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” being adopted by the regulatory bodies of the European Union (EU), Japan and USA.

Webinar Includes : All the training handouts , certificate ,Q/A and 180 mins Live Webinar

Why Should You Attend

It has often been stated that “FDA inspects for compliance; European inspectors inspect for adequate science”. Yet GMPs have been enshrined into law for many countries and a drug/biologic/medical device manufacturer should have a reasonable expectation of all inspections being the same.

ICH Q7 was established by US / EU and Japan to harmonize inspections in their respective countries. This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.. After this event, you will be fully prepared for cGMP regulatory inspections in those countries.

Webinar Takeaway

US, EU, Japan GMP Requirements (Practical ICH Area Differences, Healthcare Authority Inspection Focus)

U.S., EU and Japan GMPs - Status of Harmonization& Future Trends

  • Current status of harmonization of GMP requirements
  • Future Trends

Where Inconsistencies Become a Problem: WHO, ICH, Countries

  • Discrepancies in global expectations
  • Alignment issues

Key Chapter Reviews

  • ICH GMP organization
  • Category reviews

Compliance with ICH Guidelines for GMPs

  • Understanding and Insight into Healthcare Authority expectations
  • How GMP requirements/inspections can differ with a single ICH Standard
  • How regulators (from 3 regions) will assess / enforce compliance with Q7

APIs

  • Auditing API facilities
  • Typical audit agenda
  • ICH Area differences

Finished Products

  • Auditing finished product facilities
  • Typical audit agenda
  • ICH Area differences

Excipients

Sterile products

Biologics

Clinical Packaging

Area GMP Inspections

  • Differences on how GMP inspections are conducted
  • Areas of GMP inspection focus by area
  • Modifying your self-inspection systems to customized area concerns

Outsourcing Management Regional Perspective on:

  • Contract manufacturing
  • Contract packaging.
  • 3rd Party Contract testing

Auditing Your Facilities for Global Considerations

  • Importance of pre-audits to regional GMP focus.
  • How to focus your internal audits to a US, EU and Japan compliance system.

Who Will Benefit

  • Manufacturing
  • Quality Control
  • Quality Assurance
  • Senior Management
  • Project Managers
  • Qualified Persons (QPs)
  • Regulatory Compliance
  • CMC Personnel
  • Packaging Experts
  • Auditors and Staff
  • IT Subject Matter Experts

Choose a Purchase Options

$499

Live Webinar - Single Participant + 90 days access

You get one log-in for the live 180-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email . On Demand Access for 90 days is Included

$795

Live Group Up to 5 Participants + 12 month access

You get 5 log-in for the live 180-minute webinar for all the participant, presentation materials and the opportunity to ask questions by phone and email. 12 month Recorded access is included

$599

Recorded Access - 12 month Access

You'll have 12 month group access to log-in for an archived recording of the entire 180-minute webinar, including the Q&A period . You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session


Faculty Kelly Thomas

Faculty Kelly Thomas


Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.  

Our Participants Testimonial


The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals