Life is a Journey..how to make the best of it!

BayBiotech.NET A premarket notification from a manufacturer must include either a summary of the 510(k) safety and effectiveness information of the product upon which the substantial-equivalence determination is based or a statement that this information will be made available by the 510(k) applicant to any person within 30 days of a written request. As per FDA definition, these are the definition of Summary and Statements: Summaries are released by FDA regarding a 510(k) clearance when requested under the Freedom of Information (FOI) Act whereas Statements are used to arrange for this FOI request to be fulfilled by the 510(k) applicant. 510(k) Summaries: If a summary is included, it must be submitted with the 510(k) notification as per FDA guidelines. The summary must be complete and correct in order for FDA to complete its review of a 510(k) submission. FDA will accept summaries and amendments until it issues a determination of substantial equivalence. If a summary has be

BayBiotech.NET Protected Health Information or individually identifiable health information relates to the data about demographics, individual’s past, present or future physical or mental health or condition, provision of health care to the individual, or the past, present, or future payment for the provision of health care to the individual. Individually identifiable health information includes many common identifiers such as name, address, birth date and social security number. A covered entity (health plan, a health care clearinghouse, or a health care provider) must obtain the individual’s written authorization for any use or disclosure of protected health information that is not for treatment, payment or health care operations or otherwise permitted or required by the Privacy Rule. Principle of “Minimum Necessary” Use and Disclosure Principle of “Minimum Necessary” is the central aspect of the privacy rule. Under this principle, it is expected that a reasonable effort mu

Quality Assurance and Compliance: Requirements for Batch Production Records BayBiotech.NET

BayBiotech.NET Batch Production Record is an example of a GMP document and is designed to standardize the process and provides with lot-specific information. GMP Requirements for Batch Records are defined under following FDA regulations:  Master Batch Record 21 CFR 211.188  21 CFR 211.194—Laboratory Records  21 CFR 211.194—Review by the Quality Control Unit A batch production record must be established every time a batch is manufactured and must include the following: Requirements for Laboratory Operations •Establish and follow written procedures for laboratory operations •Use adequate laboratory facilities •Requirements for Laboratory control processes •Methods for testing and examination Requirements for Manufacturing Operations •Establish and follow written procedures for manufacturing operations •Ensure product specifications are consistent •Adequate sanitation principles •Prevent contamination •Appropriate disposition of rejected or unsuitable dietary supple

BayBiotech.NET Dear All, Happy 2010! I plan to focus on the main components of an informed consent in this blog. Enjoy! Informed consent (21 CFR 50.20, 21 CFR 50.25(a), and 21 CFR 50.25(b)) is a document prepared for the subjects who may be benefited from a clinical trial and provides the key facts about a clinical trial before deciding whether or not to participate. In order to help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided for them. Main component of an informed consent document are the key details about the study, such as its purpose, duration, required procedures, key contacts as well as risks and potential benefits associated with it. The participant then decides whether or not to sign the consent and participate in the study. Informed consent is not a contract, and the participant may withdraw

BayBiotech.NET Built environments both residential and non residential are subject to number of indoor air quality (IAQ) and Indoor environment (IE) problems that may cause acute symptoms, health risks or discomfort. A frequent IAQ and IE investigations can determine the occurrence of BRI and provide with healthier work environment. This is of utmost importance for Pharmaceutical/ Life Sciences industry where the product is directly subject to the human usage. Non residential buildings are more prone to BRI as there is a high volume of occupants coming from diverse geographical areas interact in an environment where the ventilation of the building is not directly under the occupants control. Health hazard evaluation teams from the National Institute of Occupational Safety and Health (NIOSH) conducts the investigation upon request and provides with strategies to avoid the recurrence of the problem. Some of the risk factors that may be used to evaluate biological contaminants as pot

BayBiotech.NET Scope: the policy applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research. This policy does not affect any state, local or foreign laws or regulations which may otherwise be applicable and which provide additional protections for human subjects. Exclusions:  Research conducted in educational settings, examples: research on education instructional strategies, on comparison among instructional techniques, curricula, or classroom management methods.  Research involving survey procedures, interview procedures or observation of public behavior, unless information is recorded in such a manner that human subjects can be identified.  Research involving the collection of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or