(571) 447-5500

Drug Good Manufacturing Practices (GMP) Compliance Seminar

September 4, 5, 10, and 11, 2024 • Virtual Event

11am-4pm Eastern each day

The GMPs dictated in 21 CFR 210 have been in place for over a decade, but the FDA continues to issue numerous Warning Letters to the industry for a failure to comply with even the basic tenets of the regulation. In light of increased FDA oversight, a thorough review of industry rules for Good Manufacturing Practices (GMPS) is warranted.

In these unprecedented times, the pharmaceutical industry is playing an essential role for the U.S. consumer. Never before have more questions been raised regarding Good Manufacturing Practices (GMPs), so we are offering our Drug Good Manufacturing Practices (GMP) Compliance Seminar course virtually.

GMPs, dictated in 21 CFR 210, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Drugs, have been in place for over a decade. Even with the Food and Drug Administration’s (FDA) efforts to ensure consistent manufacturing to established product specifications, industry confusion with the basic tenets of the regulation result in numerous FDA observations and Warning Letters. A thorough understanding of 21 CFR 210, as well as other statutory requirements is critical for compliance and safety for the consumer, both of which are required for the success of a company.

EAS Consulting Group Drug GMP Seminar helps firms prepare for FDA enforcement by facilitating an understanding of compliance requirements for responsibilities of domestic and foreign firms who manufacture, label, pack or hold pharmaceuticals for sale in the United States, including those involved with the testing, quality control and distribution of drugs.

Instructed by two cGMP experts with 30+ years combined industry experience this intensive training program will help your firm stay on top of cGMP requirements.

Who Should Attend?

  • Individuals involved in management, regulatory affairs, and quality control/assurance in the manufacturing, labeling, packaging, storing and distribution of drugs.
  • Consultants, auditors, attorneys and others interested in learning about the requirements of the new drug GMPs and how they should be applied.

At the Drug GMP Seminar, You Will

  • Learn all of the requirements of 21 CFR 210 and other applicable statutory requirements.
  • Receive detailed practical guidance on how to apply these requirements at your facility.
  • Get coaching on how to prepare for an FDA inspection and avoid receiving a List of Objectionable Inspection Observations (Form FDA 483).
  • Be given an opportunity to demonstrate your understanding of GMPs in group work sessions.

Instructors

Shelly Blackwell

Shelly Blackwell

EAS Senior Director for Dietary Supplement and Tobacco Services

Shelly Blackwell brings over 22 years of quality and compliance experience in highly regulated environments to the EAS Consulting Group. After starting her career as a Microbiologist, she gained expert knowledge of a variety of domestic and international regulations while holding senior leadership positions in the dietary supplement, pharmaceutical, and medical device industries. These positions include 7 years as the Quality Assurance Director for GNC / Nutra Manufacturing and most recently leading the Quality Systems and Compliance Team at Bausch and Lomb in Greenville, SC.

Shelly’s accomplishments while leading Quality teams include developing supplier qualification programs, sourcing and implementing electronic QMS systems, implementing inspection readiness programs resulting in improved regulatory standing, risk-based quality system development, data integrity program development, and numerous successful continuous improvement initiatives. She has lead FDA and other regulatory inspections throughout her career and is also a lead auditor herself, auditing raw material suppliers and finished product manufacturers all over the world. Shelly holds certifications from the American Society of Quality and the Institute of Food Technology and has a Biology degree from James Madison University.

Jeb Hunter

Jeb Hunter

EAS Senior Regulatory Consultant

Jeb S. Hunter holds a BS in Microbiology from Clemson University and has spent his career in Quality, starting in a microbiology and chemistry laboratory setting and moving into auditing and managing Quality Management Systems. Jeb has experiences in the Pharmaceutical, Medical Device, Dietary Supplement, and Food/Tobacco industries. He is a highly capable team auditor and Lead Auditor across auditing platforms with audits conducted against a host of regulatory standards both domestic and international.

Registration

$749.00$849.00

All seminar registrations are per person.

Discounts

Federal and State Employees may be eligible for a 50% discount. Contact Jessica Lloyd for more details.

Two or more employees from the same firm will receive a 10% discount, auto applied in cart within the same transaction.

* Only one discount code per transaction

Cancellation Policy

EAS reserves the right to cancel the seminar if minimum participation has not been met two weeks prior to the start of the seminar. All registrations will be refunded in full.

Cancellations will be refunded minus a $95 processing fee up to two weeks prior to the start date of the seminar. After this date, no refunds will be given.

Terms and Conditions

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On-line Training

The EAS Consulting Group Dietary Supplement GMP Seminar will be conducted virtually through Zoom. A link will be provided to each participant. To ensure an understanding with the instructional material, live student attendance and active participation in discussions via webcam is required. At the conclusion of the training, students must complete a GMP exam with an acceptable score in order to receive their certificate of training. Each attendee will receive the entire presentation and a Pocket Guide in advance of the course.

Virtual Seminar Dates and Times

The virtual seminar will take place from 11:00am – 4:00pm eastern. Please verify your schedule prior to registration. Attendance at each seminar date is expected.

In-House Seminar

EAS will conduct this seminar for individual firms upon request. Bringing the seminar in-house at your facilities can be a cost-effective alternative to train your employees. It also allows the program to be tailored to your particular needs. Contact us for a price quote. (571) 447-5500.

For More Information or Questions

Contact Jessica Lloyd at (571) 447-5508 or trainings@easconsultinggroup.com