Currently Being Offered:

April 16-18

Course Overview:

Guidelines introduced by FDA and the European Medicines Agency (EMA) represent a paradigm shift in the process validation approach. These guidance documents incorporate the “lifecycle” concept into the validation process. These guidelines are not based on conformance to a fixed set of protocols, but are designed using a risk-based approach that identifies and controls potential risks within the manufacturing process. These guidelines consider the validation as an exercise that is meant not only to achieve process understanding and consistency, but also to provide ongoing verification, which make sure that the process remains within its validated design space and consistently produces product that meets all specifications. Manufacturing processes for biopharmaceuticals must be designed to produce products that have consistent quality attributes. Manufacturing processes should be validated by applying a scientifically rigorous and well-documented exercise demonstrating that the process, and every equipment used in it, consistently performs as intended, and that the process, when operated within established limits, generates a product that routinely and reliably meets its required quality standards.

This three-day course introduces the basic concepts and principles of pharmaceutical process validation to professional scientists and engineers who are new to the field.

Additional Information:

Participants should arrive around 8:30, training begins at 9am and concludes around 5pm. A light continental-style breakfast, lunch and one-course dinner are provided each day.

For out of town guests, some nearby accommodations are below:

Residence Inn by Marriott Philadelphia Montgomeryville

Address: 1110 Bethlehem Pike, North Wales, PA 19454

Phone: (267) 468-0111

Hampton Inn & Suites Philadelphia Montgomeryville

Address: 121 Garden Golf Blvd, North Wales, PA 19454

Phone: (215) 412-8255

Courtyard by Marriott Philadelphia Montgomeryville

Address: 544 Dekalb Pike, North Wales, PA 19454

Phone: (215) 699-7247

Candlewood Suites Philadelphia-Willow Grove

Address: 250 Business Center Dr., Horsham, PA 19044

Phone: (888)-614-3125

FAQs

What's the refund policy?

For refund policy, please contact Lyn Kugel.