5 Hours Webinar : GMP’s in practice: quality systems, common sense compliance, and application

10:00 AM EDT | 07:00 AM PDT | 09:00 AM CDT Duration 300 Minute

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 5 Hrs Live Webinar

"Hear By Dr. Ginette Collazo — a 15 year veteran of helping drug, biologic and device firms reduce manufacturing errors"

12:30 Pm to 1:30 Pm Break


Description: This course covers all GMP 211 sub-parts including Part 11 and electronic batch records. Also, this course covers more than 30 elements of a modern quality system, it’s requirements, expectations, and examples. Each element is explored with applicable regulation from US FDA, Health Canada, European Union WHO and ICH (for multinationals). 
Design: Content based, experiential (real site specific examples), 483’s evaluation and Warning Letter discussions. Case studies. 

Why should you attend:

Recently, the FDA has issued an increasing number of warning letters citing inadequate employee GMP training.

Meanwhile, companies consistently claim their employees are trained and they can prove it by presenting stacks of sign-in sheets from training sessions. This is the training hoax —operators are told in just a few hours about the contents of hundreds of pages of SOPs.

As a result, these reportedly trained professionals can’t possibly have learned the material and have little recollection of procedures or knowledge of how to handle deviations, resulting in defects, recalls and other product problems that cost companies untold billions of dollars.

Unfortunately, GMP trainers are often expected to do just that — create a training course, get everyone’s signature on the training sign-in sheet and hope that people will work differently. For training to be truly effective, organizations must move from a training environment to a learning environment

Areas Covered

1.    Management and Supervision Responsibilities
2.    Quality Risk Management
3.    Knowledge Management and Organizational Learning
4.    Quality Management and Quality Systems
5.    Product and Process Monitoring
6.    Discrepancy Observation and Investigation
7.    Complaints
8.    Qualification and Validation
9.    Learning, Training and Performance
10.    Documents, Records and Recordkeeping
11.    Change Management
12.    Corrective Action and Preventive Action (CAPA)
13.    Materials and Packaging Components
14.    Vendors, Third Parties, and Outsourcing
15.    Sampling
16.    Equipment Cleaning
17.    Sanitation
18.    Facilities and Utility Systems
19.    Warehousing and Storage
20.    Distribution Practices
21.    Maintenance, Repair, and Calibration
22.    Materials Receiving
23.    Equipment
24.    Manufacturing and Packaging
25.    Identity Control
26.    Label Control
27.    Batch Release
28.    In-process Controls
29.    Clothing and Personal Hygiene

Who will Benefit

•    Compliance officers
•    Consultants/service providers
•    Engineering and design control teams
•    Executive management
•    Managers
•    Manufacturing directors and supervisors
•    Procedure writers
•    Pharmaceutical and cGMP auditors
•    QA/QC personnel
•    R&D staff
•    CAPA specialists
•    Training personnel
•    Instructional designers and technologists

Industries who can attend

This 5 Hrs online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

DR. Ginette M. Collazo

DR. Ginette M. Collazo has spent more than 15 years in technical training, organizational development and human reliability. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth and Medtronic, many more small and mid-sized drug and device companies. An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics.

Dr. Ginette M. Collazo obtained her PhD in Industrial/Organizational Psychology from the Interamerican University of Puerto Rico. Ginette has over 15 years of experience in the pharmaceutical industry with the Technical Training, Organizational Development and Human Reliability fields.

Currently she is the president of Ginette M. Collazo, Inc. a firm that works with organizations to improve productivity by helping them identify and implement innovative strategies that will warrant that business objectives and results are met and exceeded. GMC, Inc. specializes, also, in Human Error reduction allowing organizations to achieve savings and reduce/avoid unnecessary costs associated with people’s mistakes.

Ginette’s clients all over the world including Germany, Argentina, USA, Trinidad Tobago, Dominican Republic, Singapore, Europe, and more. She has been a guest speaker about these topics in several professional conferences including American Institute for Chemical Engineers Global conference, Center for Chemical and Process Safety, American Society for Quality, California State Lands Commission Prevention First 2010 conference, Interphex PR and NY, FDAnews, among others.

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