Basic and update Training on Good Manufacturing Practices

June 26, 2013 - PRLog -- Why to attend:

FDA and equivalent international agencies require documented and certified knowledge of GMPs for all personnel working in GMP environments. Typically such knowledge is provided through initial GMP training for new and employees and through annual refresher training  for existing staff.  Lack of adequate training especially in the area of GMP knowledge is a key inspection issue as training plans should include basic and an-going GMP knowledge for everybody working in an FDA or international GMP environments. This includes all management levels and also IT staff and software developers. Typically trainees have many questions. This seminar will have the answers. During the seminar, the speaker will give an introduction on GMP and the requirements. After the seminar, an extensive list of application specific reference material like SOPs, checklists, templates and examples will be available for further practice that  help immediate and effective implementation.

Areas Covered in the Seminar:

* FDA and International GMP regulations
* Understanding the business benefit of GMPs
* Difference between GMP and non-GMP work
* GMP for drug substances and drug products
* Management and organizational requirements
* Requirements for building and facilities
* Requirements for equipment and computer systems
* Requirements for packaging and labeling
* Responsibilities of management, QA, and all employees
* Required standard operating procedures and how to efficiently use them
* Data generation and evaluation: raw data, intermediate and final results
* Records keeping: format, length of time, archiving and reprocessing
* Going through examples of most recent frequently found deviations
* Preparing for GMP inspections to avoid warning letters

And for easy and instant implementation:
download 10+ documents from special seminar website.
They include

* 120 pages primer: GLPs and GMPs
* SOP: Generation and Maintenance of SOPs
* SOP: Handling Deviations from Standard Operating Procedures
* SOP: Training for GMP Compliance  
* SOP: Facilities and Environmental Control
* SOP: Multinational GMP inspections - Preparation, Conduct, Follow-up
* SOP: Corrective and Preventive Actions
* Checklist: Good Manufacturing Practices
* 20+ GMP related FDA warning letters
* PowerPoint Presentation
* Script of the presentation
* All questions and answers from before, during and after the seminar


Date:  August 15, 2013
Time: 11.00 - 12.00 a.m. ET
Location: Online, worldwide

Who should attend
* (Bio)Pharmaceutical, Device and API Industry
* QA managers and personnel
* Analysts and lab managers
* Validation specialists
* Training departments
* documentation department
* Consultants


Weblink:  http://www.labcompliance.com/seminars/audio/319/default.aspx