Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here.

On-line Audio Seminar 154

Current Good Manufacturing Practices

Basic Intro, requirements and impact on your organization

Recorded

Complying with CGMP regulations can increase the cost of an operation up to 30%. Companies or employees either don't know exactly what CGMP really means, what procedures are required and how to implement CGMP regulations. Lack of GMP knowledge is also an inspection issue as training plans should include basic GMP knowledge for everybody working in an FDA or international GMP environment.

Frequent Questions related Good Manufacturing Practices are:

• What is cGMP?
• Who has to comply with cGMP regulations?
• What are the differences between FDA and international cGMP regulations?
• What is the differences between GMP and non-GMP work?
• What are the key cGMP requirements?
• What are the responsibilities of operators, supervisor, QA and management?
• Why do we need SOPs?
• How to document GMP data?
• How to prepare the organization and staff for a cGMP inspection?
• What are the most frequently found deviations and how can we avoid them?

How does the audio seminar help:

A good understanding of cGMP regulations and current FDA interpretations together with a good strategy for implementation not only can keep the costs under control but provides a high assurance that your company will pass FDA and other GMP inspections. Answers to the questions above will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will give an introduction on cGMP and the requirements. After the seminar, an extensive list of reference material like SOPs, checklists, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

• FDA and International GMP regulations
• Difference between GMP and non-GMP work
• Organizational requirements
• Requirements for building and facilities
• Requirements for equipment and computer systems
• Requirements for packaging and labeling
• Responsibilities: Management, QA, all employees
• Required standard operating procedures
• Data generation and evaluation: raw data, intermediate results, final results
• Records keeping: format, length of time, archiving and reprocessing
• Preparing for GMP inspections

And for easy and instant implementation:
download 10+ documents from dedicated seminar website

• 120 pages primer: Good Laboratory Practices and Current Good Manufacturing Practices: 120 pages primer
• Gap Analysis/Checklist: Good Manufacturing Practice Regulations
• Worksheet: Laboratory audits
• SOP: Generation and Maintenance of SOPs
• SOP: Handling Deviations from Standard Operating Procedures
• SOP: FDA inspections - Preparation, Conduct, Follow-up
• SOP: Training for GMP Compliance
• SOP: Building a GMP System for International Environments
• SOP: Facilities and Environmental Control
• SOP: Equipment Qualification
• SOP: Multinational GMP inspections - Preparation, Conduct, Follow-up
• SOP: Corrective and Preventive Actions
• FDA Inspection Manual; Drug Manufacturing
• SOP for EMEA GMP Inspections
• FDA Warning Letters and inspectional observations related to GMP
• Frequently asked questions and answers related to GMP
• 21 CFR Part 211: Good Manufacturing Practice Regulations for Finished Drugs
• All FDA cGMP Regulations (drugs, devices)
• FDA and ICH Guidance for APIs
• And more...

Who should attend?

• Everybody working in GMP environments
• QA managers and personnel
• IT managers and personnel
• Production and lab managers
• Packaging and labeling
• Manufacturing and shipping departments
• Validation specialists
• GMP Auditors
• Consultants
• Teachers

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web download 'Site' offer Multiple persons - single site Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site. Order includes all reference material.	US$ 349.-
Recorded seminar - CD Get the CD in your mail Order includes all reference material.	US$ 349.-
Special offer for Labcompliance Usersclub Members Recorded Seminar- CD or Web download. Order includes all reference material. for Usersclub information and registration, click here	US$ 249.-

About audio seminars

 

Online audio seminars are presented over the phone. During the live presentation attendees can:

1. Study the printed slide material
2. Watch the slides on a computer
3. Watch the slides on a video screen in a seminar room
4. Ask questions through email and web form

 

About Dr. Ludwig Huber

Dr. Ludwig Huber is the author of the Labcompliance Newsletter. He has been conducting over 100 web and audio or video based seminars since ten years. He is worldwide director for FDA compliance at Agilent Technologies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visits FDA in Rockville, VA, and participates in panel discussions with FDA professionals. For more information, click here.