Cost Effective and Convenient - in your office or conference room
Getting it Right!
Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.
FDA expects pharmaceutical manufacturers to be in control of the environmental conditions within the manufacturing facility. Controlling the environmental condition is not only a regulatory requirement but also part of protecting and producing a quality product. This presentation will define what is meant by environment, what conditions are required and how such conditions may be dictated by the type of product being processed.
We will discuss how to obtain the desired environmental conditions, manage the conditions within the space, and what is required to ensure that the environmental conditions remain in a state of control. We will define standard environmental conditions to be maintained in manufacturing space based on published standards and compendial documents. A hypothetical biotech manufacturing facility will be used as an example to show the use of various conditions as they apply to various activities with the processing of a Biotech product.
We will describe various methods to monitor such conditions and where to monitor within the space. The frequency of the monitoring will be reviewed based on the criticality of the activity being performed in the space. We will emphasize how to collect the data and what to do with the data once collected. Trending, identifying alert and action levels will be defined and possible preventive and corrective actions will be reviewed.
Throughout the presentation we will review actual FDA 483 observation as they relate to environmental monitoring to emphasize the issues of most concern to the regulators. We will allow some time for Q&A at the conclusion of the seminar.
Environmental Monitoring: Getting It Right!
Part I - Controlling the manufacturing environment
- Identifying the regulatory requirements
- Defining the environment
- How to control the environment
Part II - Environmental monitoring and how to do it
- Using an example of a fictitious manufacturing facility, you will learn:
- The basic methods to monitor the environment
- Where to monitor within the space
- What variables you should monitor
- The frequency of monitoring
- What to look for to identify potential problems
Don’t like to order online? Call us at 714-289-1233
All registrations include handout materials. Once you’re registered, you will receive via e-mail (the e-mail address you provide in your registration) the presentation handout materials the day before the seminar.
We accept Visa, MasterCard, and American Express (AMEX). All prices are in US dollars.
Note: Our shopping cart is set to the highest security level. Please make sure that the address corresponds to the credit card holder. It may result in a declined order if the address doesn't match the address on file for the cardholder named on the credit card.
Please enter your billing information EXACTLY as it appears on your credit card statement.
|Get the Audio recording and presentation file
GMP131004E - audio recording and handout materials
Environmental Monitoring: Getting it Right!
Gamal Amer, Ph.D.
Gamal Amer, Ph. D. is Principal at Premier Compliance Services, Inc.; Management Consultants for compliance and manufacturing operations performance in the life sciences industry. He holds a Ph. D. in Chemical Engineering and has over two decades experience in the Pharmaceutical and related industries. He has held positions of increased responsibility with leading pharmaceutical, consumer product and engineering consulting firms over the years. His experience includes comprehensive process design in bulk pharmaceutical manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations.
Dr. Amer is a recognized expert in GMP compliance and validation. He has consulted for many of the leading pharmaceutical, biotechnology and medical device manufacturers. He has lectured extensively in the US, Europe, Asia and the Middle East, taught many courses, and authored many papers which were published in peer reviewed publication. He is a member of ISPE, PDA, ACS and AIChE.
Please forward this to your colleagues who may be interested.